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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
Total serum bilirubin ≤2.0 mg/dL (unless has Gilbert's disease or leukemia involvement of the liver, then ≤3.0)
Evidence of active BAFF-R expression 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

Study 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.Check my eligibility
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.See study design
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 total bilirubin level is 2.0 mg/dL or less, or 3.0 if I have Gilbert's disease or liver-involved leukemia.
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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 may need a thorough liver check-up if recommended.
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I've had many transfusions and a bone marrow transplant, and may need a liver MRI for iron overload.
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My leukemia has spread to my brain but I don't have symptoms.
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I cannot receive or did not respond to previous CD19-targeted immunotherapy.
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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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My cancer is confirmed as B-ALL or B-cell lymphoblastic lymphoma.
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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.
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I am 18 years old or older.
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I can take care of myself and perform daily activities.
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My cancer shows active BAFF-R expression.
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I have recovered from previous cancer treatment side effects, except for hair loss.
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I have no allergies or adverse reactions to leukapheresis, steroids, or tocilizumab.
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My kidneys are working well, as shown by tests.
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My condition worsened after at least 2 treatments failed.

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.
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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events
Secondary outcome measures
B cell frequency
Disease response
Minimal residual disease (MRD)
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: BAFFR-CAR T cellsExperimental Treatment1 Intervention
B-cell activating factor receptor-Chimeric antigen receptor T cells

Find a Location

Who is running the clinical trial?

PeproMene Bio, Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
City of Hope Medical CenterOTHER
561 Previous Clinical Trials
1,918,228 Total Patients Enrolled
Ibrahim Aldoss, MDPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials

Media Library

BAFFR-CAR T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04690595 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: BAFFR-CAR T cells
Acute Lymphoblastic Leukemia Clinical Trial 2023: BAFFR-CAR T cells Highlights & Side Effects. Trial Name: NCT04690595 — Phase 1
BAFFR-CAR T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04690595 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~11 spots leftby Nov 2026