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CAR T-cell Therapy

CAR-T Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1

Recruiting

Led By Ibrahim Aldoss, MD

Research Sponsored by PeproMene Bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of active BAFF-R expression at the time of enrollment.

Relapsed/refractory disease after failure of ≥ 2 prior lines of therapy.

Must not have

Auto-immune disease or active GVHD within 6 months prior to protocol enrollment requiring systemic immunosuppressant therapy.

Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from t cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new CAR T cell treatment for relapsed or refractory B-cell acute lymphoblastic leukemia.

Who is the study for?

Adults over 18 with B-cell Acute Lymphoblastic Leukemia that's come back or hasn't responded after at least two treatments. They must have BAFF-R on their cancer cells, be in decent physical shape (ECOG ≤ 2), and not pregnant or breastfeeding. People who've had certain other cancers, immune diseases, severe heart problems, recent transplants, or are HIV/HCV positive can't join.

What is being tested?

The trial is testing a new therapy using T cells engineered to target BAFFR on leukemia cells for patients whose leukemia has returned or resisted treatment. It's an early-phase study to see how safe it is and what effects it might have.

What are the potential side effects?

Possible side effects include reactions related to the infusion of CAR-T cells, increased risk of infections due to immune system suppression, potential liver enzyme changes, and other organ-related inflammations as seen with similar therapies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer shows active BAFF-R expression.

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My condition did not improve after at least 2 different treatments.

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I had CD19-CAR T cell therapy over 90 days ago and less than 5% of those cells remain before my next procedure.

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I have recovered from previous cancer treatments, except for hair loss.

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I meet all the required conditions.

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I have had CD19-CAR T cell therapy before.

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I am 18 years old or older.

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My cancer is confirmed as B-ALL or B-cell lymphoblastic lymphoma.

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I can take care of myself and do some daily activities.

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I have tried or cannot receive CD19-targeted immunotherapy.

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My kidneys are functioning well, as shown by tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't needed strong medication for an autoimmune disease or graft-versus-host disease in the last 6 months.

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I had a stem cell transplant within the last 100 days.

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I have a history of optic neuritis or other immune-related CNS conditions, including seizures.

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I have a bleeding disorder like von Willebrand's disease or hemophilia.

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I have had venous occlusive disease or graft-versus-host disease.

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I have severe heart problems that limit my daily activities.

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I do not have any uncontrolled serious illnesses.

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I have a history of HIV, hepatitis B, or hepatitis C.

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I am currently fighting an infection that needs antibiotics.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from t cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from t cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from t cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years. for reporting.