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CAR-T Cell Therapy for Acute Lymphoblastic Leukemia
Study Summary
This trial is testing a new CAR T cell treatment for relapsed or refractory B-cell acute lymphoblastic leukemia.
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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- My total bilirubin level is 2.0 mg/dL or less, or 3.0 if I have Gilbert's disease or liver-involved leukemia.I haven't needed strong medication for an autoimmune disease or graft-versus-host disease in the last 6 months.I had a stem cell transplant within the last 100 days.I am not on long-term steroids or immune-weakening drugs, except for low-dose or inhaled steroids.I have a history of optic neuritis or other immune-related CNS conditions, including seizures.I have a bleeding disorder like von Willebrand's disease or hemophilia.My cancer shows active BAFF-R expression.My condition did not improve after at least 2 different treatments.It has been over 90 days since my last CD19-CAR T cell therapy.My leukemia has spread to my brain but I don't have symptoms.I had CD19-CAR T cell therapy over 90 days ago and less than 5% of those cells remain before my next procedure.I've had many blood transfusions and a bone marrow transplant, and may have too much iron in my liver.I may need a thorough liver check-up if recommended.I've had many transfusions and a bone marrow transplant, and may need a liver MRI for iron overload.My leukemia has spread to my brain but I don't have symptoms.I cannot receive or did not respond to previous CD19-targeted immunotherapy.I may need a thorough liver check-up if recommended.I have recovered from previous cancer treatments, except for hair loss.I meet all the required conditions.I have had venous occlusive disease or graft-versus-host disease.My cancer is confirmed as B-ALL or B-cell lymphoblastic lymphoma.I have had CD19-CAR T cell therapy before.I had mild skin or GI issues after a transplant, but they are now resolved.I have not had a stroke or brain bleed in the last 6 months.I have severe heart problems that limit my daily activities.My heart rhythm problem is not stable even with medication.I had cancer before, but it was either removed surgically, treated on the skin, or has been inactive for over 3 years.I do not have any uncontrolled serious illnesses.I have a history of HIV, hepatitis B, or hepatitis C.I am currently fighting an infection that needs antibiotics.I am not pregnant or breastfeeding.You are expected to live for at least 4 months.I am 18 years old or older.My cancer is confirmed as B-ALL or B-cell lymphoblastic lymphoma.I can take care of myself and do some daily activities.I have tried or cannot receive CD19-targeted immunotherapy.I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.My kidneys are functioning well, as shown by tests.I haven't taken immunosuppressant medications in the last 3 months.I am 18 years old or older.I can take care of myself and perform daily activities.My cancer shows active BAFF-R expression.I have recovered from previous cancer treatment side effects, except for hair loss.I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.My kidneys are working well, as shown by tests.My condition worsened after at least 2 treatments failed.
- Group 1: BAFFR-CAR T cells
- 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
Has the Food & Drug Administration sanctioned BAFFR-CAR T cells for clinical use?
"The safety of BAFFR-CAR T cells is rated a 1 on the scale due to it being in its initial testing phase with limited evidence supporting both effectiveness and security."
Are there any remaining vacancies in this clinical trial for participants?
"Per the information on clinicaltrials.gov, this research project is actively recruiting participants and was first launched on May 18th 2021 before being updated November 3rd 2022."
What is the capacity of this experiment?
"Affirmative. Clinicaltrials.gov shows that this examination is presently recruiting members, with the research having been first advertised on May 18 2021 and most recently modified November 3 2022. 24 participants are needed from a single medical facility for this investigation to proceed."
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