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CAR-T Cells for Lymphoma
Study Summary
This trial will test a new immunotherapy treatment for people with B cell malignancies that have failed other treatments. The trial will evaluate the safety and efficacy of the new treatment and the feasibility of manufacturing it.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer can be measured by scans or has affected my bone marrow.I have severe side effects from past treatments not caused by my disease.My kidney function is good, with creatinine clearance over 60 ml/min and serum Cr at or below 1.5 mg/dL.My liver tests are within normal limits or not concerning for my condition.I have not been on dialysis for kidney failure in the last 3 months.My recent brain MRI and spinal tap show no signs of cancer in my brain or spinal fluid.I have previously received CAR T-cell therapy from a donor.I have no other cancers except for certain skin cancers or specific low-grade lymphomas.I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.I do not agree to participate in long-term follow-up.I've had brain scans and spinal fluid tests showing no current brain involvement.I have not had CAR-T cell therapy targeting CD19 or CD20 in the last 100 days or have significant remaining CAR-T cells.I have not had a stem cell transplant in the last 100 days, do not have GVHD, and am not on immunosuppression.I have a serious autoimmune disease or need high doses of steroids to control it.I developed a severe form of lymphoma or leukemia after an organ transplant.My platelet count is above 50,000 without recent transfusions.You have a history of following your prescribed treatment plan.I have not received anti-CD20 antibody treatment in the last 4 weeks.My white blood cell count is healthy without recent strong medication.My liver is working well.I have an active HIV, Hepatitis B, or C infection.I am able to care for myself but may not be able to do active work.I haven't had chemotherapy other than for lymphodepletion in the last 14 days.My platelet count is above 50,000 without recent transfusions.I haven't had chemotherapy or high-dose steroids in the weeks before my CAR-T cell collection.I haven't received IV fluids in the last 24 hours.My cancer has spread to my brain or spinal cord.I am able to care for myself but may not be able to do active work.My white blood cell count is healthy without recent strong medication.You must have a certain number of CD3 cells in your blood.Requirements that all patients must meet to be eligible for the clinical trial.My kidneys are working well.I haven't taken oral chemotherapy or antibody treatments in the last 7 days.I haven't had anti-CD19 antibody treatment in the last 4 weeks.I am between 18 and 80 years old with B-cell non-Hodgkin Lymphoma that has come back or didn't respond to treatment.My heart and lungs are working well.You are likely to live for at least 12 more weeks.You are currently participating in another clinical trial for a different treatment or taking experimental medications.
- Group 1: 8/12 Day Production of CAR-T for NHL
- Group 2: 8/12 Day Production of CAR-T for CLL
- Group 3: 8/12 Flexible Manufacturing with Mandated Cryopreservation
- Group 4: 8/12 Day Production of CAR-T for Relapsed/Refractory Primary or Secondary CNS Lymphoma
- Group 5: Phase 2 - Efficacy of CAR-20/19-T cells in MCL
- Group 6: 12-Day Production of Car-T Cells for NHL
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any open positions for participants in this experiment?
"From the information available on clinicaltrials.gov, it appears that this study is looking for participants. The trial was first announced on May 18th, 2020 and updated most recently on July 1st, 2022."
Does this experimental treatment program have an age limit?
"According to the inclusion criteria, patients aged 18-80 are able to enroll in this trial. There are 609 clinical trials that cater to patients under 18 while 3983 serve those over 65."
How can I get involved in this clinical trial?
"Patients with leukemia, lymphocytic, chronic, b-cell and between the ages of 18 to 80 can be accepted into this study. A total of 65 patients are needed for enrolment."
What is the upper limit to how many people can join this experiment?
"Yes, the information on clinicaltrials.gov indicates that this clinical trial is presently looking for candidates. The clinical trial was initially posted on 5/18/2020 and was most recently edited on 7/1/2022. The clinical trial is admitting 65 patients across 1 sites"
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