Loading clinical trials...

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

BAFFR Targeting CAR-T Cells for the Treatment of Relapsed or Refractory B-cell ALL

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

NCT04690595•PeproMene Bio, Inc.

View on ClinicalTrials.gov

Summary

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Detailed Description

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Acute Lymphoblastic Leukemia that has come back (recurrent) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize BAFFR, a protein on the surface of cancer cells. These BAFFR-specific T cells may help the body's immune system identify and kill BAFFR+ cancer cells.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Documented informed consent of the participant and/or legally authorized representative.
•2. Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study PI approval.
•3. Age ≥ 18 years.
•4. ECOG ≤ 2.
•5. Life expectancy ≥ 16 weeks.
•6. Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma
•7. Relapsed/refractory disease after failure of ≥ 2 prior lines of therapy.
•8. Evidence of active BAFF-R expression at the time of enrollment.
•9. Recovered to ≤ Grade 1 from the acute toxic effects (except alopecia) of prior anti-cancer therapy.
•10. No known contraindications to leukapheresis, steroids or tocilizumab.
+21 more criteria

Exclusion Criteria

•1. Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment.
•2. Immunosuppressant medications within 1 months prior to protocol enrollment.
•3. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. Physiologic replacement of steroids (prednisone ≤ 7.5 mg /day or equivalent) is allowed
•4. Auto-immune disease or active GVHD within 4 months prior to protocol enrollment requiring systemic immunosuppressant therapy.
•5. Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification.
•6. Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within 2 weeks of enrollment.
•7. Any abnormal liver enzyme levels (as defined ≥ULN in ALT, AST, Bilirubin and Alkaline Phosphatase levels) at time of enrollment
•8. . Subjects with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, including seizure disorder.
•9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.
•10. Known bleeding disorders (e.g., von Willebrand's disease) or hemophilia.
+11 more criteria

Locations (1)

City of Hope Medical Center

Duarte, California, United States

Key Dates

Start Date

May 18, 2021

Primary Completion Date

November 18, 2026

Completion Date

November 18, 2027

Last Updated

February 11, 2026

Enrollment

ESTIMATED participants

Conditions

Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

Interventions

BAFFR-CAR T cells

BIOLOGICAL

CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma

NCT05054257

Relapsed or Refractory B-cell Acute Lymphoblastic LeukemiaNon-Hodgkin's Lymphoma Refractory+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions