Category Archives: Cell Therapy

National Medical Commission prohibits use of stem cell therapy to treat patients with autism  Hindustan Times

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National Medical Commission prohibits use of stem cell therapy to treat patients with autism - Hindustan Times

Wang S, Sun J, Chen K, et al. Perspectives of tumor-infiltrating lymphocyte treatment in solid tumors. BMC Med. 2021;19(1):140.

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Singh AK, McGuirk JP. CAR T cells: continuation in a revolution of immunotherapy. Lancet Oncol. 2020;21(3):e16878. https://doi.org/10.1016/S1470-2045(19)30823-X.

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Zhang C, Liu J, Zhong JF, et al. Engineering CAR-T cells. Biomark Res. 2017;5:22. https://doi.org/10.1186/s40364-017-0102-y.

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Sadelain M, Brentjens R, Rivire I. The basic principles of chimeric antigen receptor design. Cancer Discov. 2013;3(4):38898. https://doi.org/10.1158/2159-8290.CD-12-0548.

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van der Stegen SJ, Hamieh M, Sadelain M. The pharmacology of second-generation chimeric antigen receptors. Nat Rev Drug Discov. 2015;14(7):499509. https://doi.org/10.1038/nrd4597.

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Roselli E, Boucher JC, Li G, et al. 4-1BB and optimized CD28 co-stimulation enhances function of human mono-specific and bi-specific third-generation CAR T cells. J Immunother Cancer. 2021;9(10). https://doi.org/10.1136/jitc-2021-003354.

Huang R, Li X, He Y, et al. Recent advances in CAR-T cell engineering. J Hematol Oncol. 2020;13(1):86. https://doi.org/10.1186/s13045-020-00910-5.

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Chmielewski M, Abken H. TRUCKs: the fourth generation of CARs. Expert Opin Biol Ther. 2015;15(8):114554. https://doi.org/10.1517/14712598.2015.1046430.

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Cho JH, Collins JJ, Wong WW. Universal chimeric antigen receptors for multiplexed and logical control of T cell responses. Cell. 2018;173(6):14261438.e11. https://doi.org/10.1016/j.cell.2018.03.038.

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Urbanska K, Lanitis E, Poussin M, et al. A universal strategy for adoptive immunotherapy of cancer through use of a novel T-cell antigen receptor. Cancer Res. 2012;72(7):184452. https://doi.org/10.1158/0008-5472.CAN-11-3890.

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Ma JS, Kim JY, Kazane SA, et al. Versatile strategy for controlling the specificity and activity of engineered T cells. Proc Natl Acad Sci U S A. 2016;113(4):E4508. https://doi.org/10.1073/pnas.1524193113.

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Xie YJ, Dougan M, Jailkhani N, et al. Nanobody-based CAR T cells that target the tumor microenvironment inhibit the growth of solid tumors in immunocompetent mice. Proc Natl Acad Sci U S A. 2019;116(16):762431. https://doi.org/10.1073/pnas.1817147116.

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Wei J, Han X, Bo J, et al. Target selection for CAR-T therapy. J Hematol Oncol. 2019;12(1):62. https://doi.org/10.1186/s13045-019-0758-x.

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Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017;130(16):18008. https://doi.org/10.1182/blood-2017-03-769620.

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Scheuermann RH, Racila E. CD19 antigen in leukemia and lymphoma diagnosis and immunotherapy. Leuk Lymphoma. 1995;18(5-6):38597. https://doi.org/10.3109/10428199509059636.

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Schuster SJ, Bishop MR, Tam CS, et al. Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. N Engl J Med. 2019;380(1):4556.

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Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet (London, England). 2020;396(10254):83952.

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Neelapu SS, Locke FL, Bartlett NL, et al. Axicabtagene Ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. N Engl J Med. 2017;377(26):253144.

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Locke FL, Miklos DB, Jacobson CA, et al. Axicabtagene Ciloleucel as second-line therapy for large B-cell lymphoma. N Engl J Med. 2022;386(7):64054. https://doi.org/10.1056/NEJMoa2116133.

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Neelapu SS, Dickinson M, Munoz J, et al. Axicabtagene ciloleucel as first-line therapy in high-risk large B-cell lymphoma: the phase 2 ZUMA-12 trial. Nat Med. 2022;28(4):73542. https://doi.org/10.1038/s41591-022-01731-4.

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Ghione P, Palomba ML, Patel A, et al. Comparative effectiveness of ZUMA-5 (axi-cel) vs SCHOLAR-5 external control in relapsed/refractory follicular lymphoma. Blood. 2022. https://doi.org/10.1182/blood.2021014375.

Jacobson CA, Chavez JC, Sehgal AR, et al. Axicabtagene ciloleucel in relapsed or refractory indolent non-Hodgkin lymphoma (ZUMA-5): a single-arm, multicentre, phase 2 trial. Lancet Oncol. 2022;23(1):91103. https://doi.org/10.1016/S1470-2045(21)00591-X.

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Grommes C, DeAngelis LM. Primary CNS lymphoma. J Clin Oncol. 2017;35(21):24108. https://doi.org/10.1200/JCO.2017.72.7602.

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Wang M, Munoz J, Goy A, et al. KTE-X19 CAR T-cell therapy in relapsed or refractory mantle-cell lymphoma. N Engl J Med. 2020;382(14):133142. https://doi.org/10.1056/NEJMoa1914347.

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Miles RR, Arnold S, Cairo MS. Risk factors and treatment of childhood and adolescent Burkitt lymphoma/leukaemia. Br J Haematol. 2012;156(6):73043. https://doi.org/10.1111/j.1365-2141.2011.09024.x.

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Russo-Carbolante EM, Picano-Castro V, Alves DC, et al. Integration pattern of HIV-1 based lentiviral vector carrying recombinant coagulation factor VIII in Sk-Hep and 293T cells. Biotechnol Lett. 2011;33(1):2331. https://doi.org/10.1007/s10529-010-0387-5.

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Tao J, Zhou X, Jiang Z. cGAS-cGAMP-STING: the three musketeers of cytosolic DNA sensing and signaling. IUBMB Life. 2016;68(11):85870. https://doi.org/10.1002/iub.1566.

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Gndara C, Affleck V, Stoll EA. Manufacture of third-generation lentivirus for preclinical use, with process development considerations for translation to good manufacturing practice. Hum Gene Ther Methods. 2018;29(1):115. https://doi.org/10.1089/hgtb.2017.098.

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Atianand MK, Fitzgerald KA. Molecular basis of DNA recognition in the immune system. J Immunol. 2013;190(5):19118. https://doi.org/10.4049/jimmunol.1203162.

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Michieletto D, Lusic M, Marenduzzo D, et al. Physical principles of retroviral integration in the human genome. Nat Commun. 2019;10(1):575. https://doi.org/10.1038/s41467-019-08333-8.

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Zhang J, Hu Y, Yang J, et al. Non-viral, specifically targeted CAR-T cells achieve high safety and efficacy in B-NHL. Nature. 2022. https://doi.org/10.1038/s41586-022-05140-y.

Doody GM, Justement LB, Delibrias CC, et al. A role in B cell activation for CD22 and the protein tyrosine phosphatase SHP. Science. 1995;269(5221):2424. https://doi.org/10.1126/science.7618087.

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Baird JH, Frank MJ, Craig J, et al. CD22-directed CAR T-cell therapy induces complete remissions in CD19-directed CAR-refractory large B-cell lymphoma. Blood. 2021;137(17):23215. https://doi.org/10.1182/blood.2020009432.

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Zhang WY, Wang Y, Guo YL, et al. Treatment of CD20-directed chimeric antigen receptor-modified T cells in patients with relapsed or refractory B-cell non-Hodgkin lymphoma: an early phase IIa trial report. Signal transduction and targeted. Therapy. 2016;1:16002.

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Du J, Zhang Y. Sequential anti-CD19, 22, and 20 autologous chimeric antigen receptor T-cell (CAR-T) treatments of a child with relapsed refractory Burkitt lymphoma: a case report and literature review. J Cancer Res Clin Oncol. 2020;146(6):157582. https://doi.org/10.1007/s00432-020-03198-7.

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Ranganathan R, Shou P, Ahn S, et al. CAR T cells targeting human immunoglobulin light chains eradicate mature B-cell malignancies while sparing a subset of Normal B cells. Clin Cancer Res. 2021;27(21):595160. https://doi.org/10.1158/1078-0432.CCR-20-2754.

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Zhang Y, Li J, Lou X, et al. A prospective investigation of bispecific CD19/22 CAR T cell therapy in patients with relapsed or refractory B cell non-Hodgkin lymphoma. Front Oncol. 2021;11:664421. https://doi.org/10.3389/fonc.2021.664421.

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Safarzadeh Kozani P, Safarzadeh Kozani P, Rahbarizadeh F. CAR-T cell therapy in T-cell malignancies: is success a low-hanging fruit? Stem Cell Res Ther. 2021;12(1):527. https://doi.org/10.1186/s13287-021-02595-0.

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Tumor buster - where will the CAR-T cell therapy missile go?

1. Gilead lands new cell therapy for Kite in $225M Arcellx deal, providing global scale for future J&J-Legend showdown  FierceBiotech
2. Gilead buys into multiple myeloma cell therapy with Arcellx deal  BioPharma Dive
3. Gilead Sciences Gets a Shot at Next-Gen Cell Therapy With $325M Arcellx Alliance  MedCity News
4. Kite and Arcellx Announce Strategic Collaboration to Co-develop and Co-commercialize Late-stage Clinical CART-ddBCMA in Multiple Myeloma  Gilead Sciences
5. Gilead Sciences' Kite, Arcellx to Develop, Commercialize Cell Therapy Treatment for Multiple Myeloma  Marketscreener.com
6. View Full Coverage on Google News

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Gilead lands new cell therapy for Kite in $225M Arcellx deal, providing global scale for future J&J-Legend showdown - FierceBiotech

What is chimeric antigen receptor (CAR)-T cell therapy?

CAR-T cell therapy is a kind of immunotherapy. It involves harnessing the power of a person's own immune system by engineering T cells to recognize and destroy cancer cells.

The FDA-approved conditions for CAR-T cell therapy include:

In order to be eligible for CAR-T cell therapy, typically you must have already received standard of care chemotherapies. Mayo Clinic doctors will evaluate you to understand how to best treat your disease and to understand if CAR-T cell therapy may be an option.

If you think you or a loved one is eligible for CAR-T cell therapy at one of Mayo Clinic's three locations, please call the phone number below to request an appointment at the location you are interested in seeking care at. Our appointment staff will work to find the specialist who can best address your questions and needs. Be sure to mention that you are interested in CAR-T cell therapy to ensure your request is routed correctly.

Mayo Clinic hematologists are happy to discuss possible referrals with doctors and allied health staff outside of Mayo Clinic. Your doctor needs to mention that you are interested in understanding whether CAR-T cell therapy may be appropriate for you. Patient appointments are scheduled Monday through Friday from 8 a.m. to 5 p.m. local time at each campus. Consultations with Mayo doctors are also available during these hours.

Minnesota: Have your doctor call the Hematology Department directly at 507-284-8707 to request an appointment for a consultation. Your doctor can also contact the Referring Provider Service (toll-free) at 800-533-1564.

Arizona: Have your doctor call the Hematology Department directly at 480-342-4800 to request an appointment for a consultation. Your doctor can also contact the Referring Provider Service (toll-free) at 866-629-6362.

Florida: Have your doctor call the Hematology Department directly at 904-956-3309 to request an appointment for a consultation. Your doctor can also contact the Referring Provider Service (toll-free) at 800-634-1417.

Mayo Clinic is typically able to offer you an appointment within one to two weeks with a provider who specializes in the type of cancer or medical condition you have. Once you have been evaluated by the necessary specialists and determined to be eligible for CAR-T cell therapy, Mayo Clinic will work with you to schedule treatment. The appointment time depends on several factors, including your condition, laboratory capacity and the number of people seeking this treatment.

CAR-T cell therapy is a newer type of cancer treatment that may be more expensive than other therapies. Not all insurance policies cover CAR-T cell therapy. The out-of-pocket cost for CAR-T cell therapy varies, depending on your insurance coverage for services at Mayo Clinic as well as for CAR-T cell therapy itself.

In order to determine if your insurance company will cover CAR-T cell therapy, please call your insurance company and ask the following two questions:

We will work with you and your health insurance company to determine if CAR-T cell therapy will be covered, if that is the recommended treatment. This includes any appeals process with the insurance company.

During your CAR-T cell therapy, you may not be able to do things you can normally do for yourself well or safely. A caregiver helps you get through this process. The caregiver provides physical and emotional support and, sometimes, acts as an advocate for you.

Some tasks a caregiver might do for you:

The caregiver also needs to be your cheerleader, someone to give you words of encouragement, keep you going, cheer you up, make you laugh and help you get through it all.

Once you have been identified as a candidate for CAR-T cell therapy, you may need to make several trips to Mayo Clinic to determine your eligibility for the therapy as well as to meet with a doctor to make a plan for your care.

Evaluation: For this initial evaluation, plan on staying near Mayo Clinic for up to five business days in order to complete needed tests.

Collection: Depending on the timing of insurance approval, the collection may occur as soon as the week following the completion of evaluation. The collection process will take a minimum of two days.

Processing: Most people return home during this phase.

Chemotherapy before infusion: From this point on, plan on being at Mayo Clinic for many weeks depending on your medical needs. During this time, you'll need to stay within 30 minutes of Mayo Clinic.

Infusion: The infusion of CAR-T cells typically takes 30 to 90 minutes. However, plan for the infusion visit to take up to six hours to allow for care before and after the infusion.

Care after infusion: You will be monitored closely for many weeks after the CAR-T cell infusion.

Initially, after your CAR-T cell therapy, you will have appointments with the Mayo Clinic team as frequently as every month. As your health improves and there are fewer signs of disease, the appointments will become less frequent. Anticipate at least annual visits to Mayo Clinic.

Because CAR-T cell therapy is a form of gene therapy, the FDA requires a 15-year monitoring.

We want to help make your travel to Mayo Clinic as easy as possible. We provide information and a variety of services to help.

Minnesota: Mayo Clinic's campus in Rochester, Minnesota, has free Concierge Services to help plan your stay, and fee-based Patient Travel Services.

At Mayo Clinic, the needs of the patient come first. The CAR-T Cell Therapy Program doctors and other specialists consult with their colleagues about your condition and recommend treatment options based on their experience and evidence-based medicine. Mayo Clinic's experts have treated people in the landmark clinical trial that led to FDA approval of this innovative therapy. This program is one of a very few such programs at select medical centers with experts trained and certified to manage CAR-T cell therapy as clinical practice.

Feb. 19, 2022

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CAR-T Cell Therapy Program - Frequently asked questions

Nine types of standard treatment are used:Surgery

Four types of surgery are used to treat lung cancer:

After the doctor removes all the cancer that can be seen at the time of the surgery, some patients may be given chemotherapy or radiation therapy after surgery to kill any cancer cells that are left. Treatment given after the surgery, to lower the risk that the cancer will come back, is called adjuvant therapy.

Radiation therapy is a cancer treatment that uses high-energy x-rays or other types of radiation to kill cancer cells or keep them from growing. There are two types of radiation therapy:

Stereotactic body radiation therapy is a type of external radiation therapy. Special equipment is used to place the patient in the same position for each radiation treatment. Once a day for several days, a radiation machine aims a larger than usual dose of radiation directly at the tumor. By having the patient in the same position for each treatment, there is less damage to nearby healthy tissue. This procedure is also called stereotactic external-beam radiation therapy and stereotaxic radiation therapy.

Stereotactic radiosurgery is a type of external radiation therapy used to treat lung cancer that has spread to the brain. A rigid head frame is attached to the skull to keep the head still during the radiation treatment. A machine aims a single large dose of radiation directly at the tumor in the brain. This procedure does not involve surgery. It is also called stereotaxic radiosurgery, radiosurgery, and radiation surgery.

For tumors in the airways, radiation is given directly to the tumor through an endoscope.

The way the radiation therapy is given depends on the type and stage of the cancer being treated.It also depends on where the cancer is found. External and internal radiation therapy are used to treat non-small cell lung cancer.

Chemotherapy is a cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. When chemotherapy is taken by mouth or injected into a vein or muscle, the drugs enter the bloodstream and can reach cancer cells throughout the body (systemic chemotherapy). When chemotherapy is placed directly into the cerebrospinal fluid, an organ, or a body cavity such as the abdomen, the drugs mainly affect cancer cells in those areas (regional chemotherapy).

The way the chemotherapy is given depends on the type and stage of the cancer being treated.

See Drugs Approved for Non-Small Cell Lung Cancer for more information.

Targeted therapy is a type of treatment that uses drugs or other substances to identify and attack specific cancer cells. Targeted therapies usually cause less harm to normal cells than chemotherapy or radiation therapy do. Monoclonal antibodies, tyrosine kinase inhibitors, and mammalian target of rapamycin (mTOR) inhibitors are three types of targeted therapy being used to treat advanced, metastatic, or recurrent non-small cell lung cancer.

Monoclonal antibodies

Monoclonal antibodies are immune system proteins made in the laboratory to treat many diseases, including cancer. As a cancer treatment, these antibodies can attach to a specific target on cancer cells or other cells that may help cancer cells grow. The antibodies are able to then kill the cancer cells, block their growth, or keep them from spreading. Monoclonal antibodies are given by infusion. They may be used alone or to carry drugs, toxins, or radioactive material directly to cancer cells.

There are different types of monoclonal antibody therapy:

Tyrosine kinase inhibitors

Tyrosine kinase inhibitors are small-molecule drugs that go through the cell membrane and work inside cancer cells to block signals that cancer cells need to grow and divide. Some tyrosine kinase inhibitors also have angiogenesis inhibitor effects.

There are different types of tyrosine kinase inhibitors:

Mammalian target of rapamycin (mTOR) inhibitors

mTOR inhibitors block a protein called mTOR, which may keep cancer cells from growing and prevent the growth of new blood vessels that tumors need to grow. Everolimus is a type of mTOR inhibitor.

See Drugs Approved for Non-Small Cell Lung Cancer for more information.

Immunotherapy is a treatment that uses the patient's immune system to fight cancer. Substances made by the body or made in a laboratory are used to boost, direct, or restore the body's natural defenses against cancer. This cancer treatment is a type of biologic therapy.

Immune checkpoint inhibitor therapy is a type of immunotherapy used to treat some patients with advanced non-small-cell lung cancer.

Types of immune checkpoint inhibitor therapy include:

See Drugs Approved for Non-Small Cell Lung Cancer for more information.

Laser therapy is a cancer treatment that uses a laser beam (a narrow beam of intense light) to kill cancer cells.

Photodynamic therapy (PDT) is a cancer treatment that uses a drug and a certain type of laser light to kill cancer cells. A drug that is not active until it is exposed to light is injected into a vein. The drug collects more in cancer cells than in normal cells. Fiberoptic tubes are then used to carry the laser light to the cancer cells, where the drug becomes active and kills the cells. Photodynamic therapy causes little damage to healthy tissue. It is used mainly to treat tumors on or just under the skin or in the lining of internal organs. When the tumor is in the airways, PDT is given directly to the tumor through an endoscope.

Cryosurgery is a treatment that uses an instrument to freeze and destroy abnormal tissue, such as carcinoma in situ. This type of treatment is also called cryotherapy. For tumors in the airways, cryosurgery is done through an endoscope.

Electrocautery is a treatment that uses a probe or needle heated by an electric current to destroy abnormal tissue. For tumors in the airways, electrocautery is done through an endoscope.

For some patients, taking part in a clinical trial may be the best treatment choice. Clinical trials are part of the cancer research process. Clinical trials are done to find out if new cancer treatments are safe and effective or better than the standard treatment.

Many of today's standard treatments for cancer are based on earlier clinical trials. Patients who take part in a clinical trial may receive the standard treatment or be among the first to receive a new treatment.

Patients who take part in clinical trials also help improve the way cancer will be treated in the future. Even when clinical trials do not lead to effective new treatments, they often answer important questions and help move research forward.

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Non-Small Cell Lung Cancer Treatment (PDQ)Patient Version

EdiGene Announces Completion of Last Patient Dosing in Phase I Clinical Trial of ET-01, its Investigational Gene-editing Hematopoietic Stem Cell Therapy for Transfusion Dependent -thalassemia  Business Wire

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EdiGene Announces Completion of Last Patient Dosing in Phase I Clinical Trial of ET-01, its Investigational Gene-editing Hematopoietic Stem Cell...

Radiation therapy uses high-energy rays or particles to kill cancer cells.

Depending on the stage of the non-small cell lung cancer (NSCLC) and other factors, radiation therapy might be used:

Different types of radiation therapy can be used to treat NSCLC. There are 2 main types:

External beam radiation therapy (EBRT) focuses radiation from outside the body onto the cancer. This is the type of radiation therapy most often used to treat NSCLC or its spread to other organs.

Treatment is much like getting an x-ray, but the radiation dose is stronger. The procedure itself is painless and each treatment lasts only a few minutes. Most often, radiation treatments to the lungs are given 5 days a week for 5 to 7 weeks, but this can vary based on the type of EBRT and the reason its being given.

Newer EBRT techniques have been shown to help doctors treat lung cancers more accurately while lowering the radiation exposure to nearby healthy tissues. These include:

Instead of giving a small dose of radiation each day for several weeks, SBRT uses very focused beams of high-dose radiation given in fewer (usually 1 to 5) treatments. Several beams are aimed at the tumor from different angles. To target the radiation precisely, you are put in a specially designed body frame for each treatment. This reduces the movement of the lung tumor during breathing.

A variation of IMRT is called volumetric modulated arc therapy (VMAT). It uses a machine that delivers radiation quickly as it rotates once around the body. This allows each treatment to be given over just a few minutes.

For more detailed descriptions of these procedures, see External Beam Radiation Therapy.

In people with NSCLC, brachytherapy is sometimes used to shrink tumors in the airway to relieve symptoms.

The doctor places a small source of radioactive material (often in the form of small pellets) directly into the cancer or into the airway next to the cancer. This is usually done through a bronchoscope, but it may also be done during surgery. The radiation travels only a short distance from the source, limiting the effects on surrounding healthy tissues. The radiation source is usually removed after a short time. Less often, small radioactive seeds are left in place permanently, and the radiation gets weaker over several weeks.

If you are going to get radiation therapy, its important to ask your doctor about the possible side effects so you know what to expect. Common side effects depend on where the radiation is aimed and can include:

Often these go away after treatment. When radiation is given with chemotherapy, the side effects may beworse.

Radiation therapy to the chest may damage your lungs and cause a cough, problems breathing, and shortness of breath. These usually improve after treatment is over, although sometimes they may not go away completely.

Your esophagus, which is in the middle of your chest, may be exposed to radiation, which could cause a sore throat and trouble swallowing during treatment. This might make it hard to eat anything other than soft foods or liquids for a while. This also often improves after treatment is finished.

Radiation therapy to large areas of the brain can sometimes cause memory loss, headaches, or trouble thinking. Usually these symptoms are minor compared with those caused by cancer that has spread to the brain, but they can affect your quality of life.

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Radiation Therapy for Non-Small Cell Lung Cancer

AvenCell to Present New Data from Lead Universal CAR T Cell Therapy Program at 64th American Society of Hematology Annual Meeting and Exposition  Business Wire

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AvenCell to Present New Data from Lead Universal CAR T Cell Therapy Program at 64th American Society of Hematology Annual Meeting and Exposition -...

Instil Bio's stock falls 35% after disclosing the cell therapy company paused enrollment in clinical trials  MarketWatch

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Instil Bio's stock falls 35% after disclosing the cell therapy company paused enrollment in clinical trials - MarketWatch

Creative Medical Technology Holdings Announces FDA Clearance of Investigational New Drug (IND) Application for AlloStem, a Novel Cell Therapy for the Treatment of Type 1 Diabetes  PR Newswire

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Creative Medical Technology Holdings Announces FDA Clearance of Investigational New Drug (IND) Application for AlloStem, a Novel Cell Therapy for the...