Active — Not RecruitingPhase 1

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

United States24 participantsStarted 2021-05-18

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Documented informed consent of the participant and/or legally authorized representative.
✓. Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study PI approval.
✓. Age ≥ 18 years.
✓. ECOG ≤ 2.
✓. Life expectancy ≥ 16 weeks.
✓. Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma
✓. Relapsed/refractory disease after failure of ≥ 2 prior lines of therapy.
✓. Evidence of active BAFF-R expression at the time of enrollment.

✕. Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment.
✕. Immunosuppressant medications within 1 months prior to protocol enrollment.
✕. 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
✕. Auto-immune disease or active GVHD within 4 months prior to protocol enrollment requiring systemic immunosuppressant therapy.
✕. Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification.
✕. Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within 2 weeks of enrollment.
✕. Any abnormal liver enzyme levels (as defined ≥ULN in ALT, AST, Bilirubin and Alkaline Phosphatase levels) at time of enrollment
✕. . 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.

Incidence of adverse events

Timeframe: Up to 1 year post treatment

NCT IDNCT04690595

SponsorPeproMene Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-18

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Documented informed consent of the participant and/or legally authorized representative.
✓. Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with study PI approval.
✓. Age ≥ 18 years.
✓. ECOG ≤ 2.
✓. Life expectancy ≥ 16 weeks.
✓. Histologically confirmed B-ALL or B-cell lymphoblastic lymphoma
✓. Relapsed/refractory disease after failure of ≥ 2 prior lines of therapy.
✓. Evidence of active BAFF-R expression at the time of enrollment.

✕. Autologous/allogeneic stem cell transplant within 100 days at the time of enrollment.
✕. Immunosuppressant medications within 1 months prior to protocol enrollment.
✕. 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
✕. Auto-immune disease or active GVHD within 4 months prior to protocol enrollment requiring systemic immunosuppressant therapy.
✕. Class III/IV cardiovascular disability according to the New York Heart Association (NYHA) Classification.
✕. Subjects with clinically significant arrhythmia or arrhythmias not stable on medical management within 2 weeks of enrollment.
✕. Any abnormal liver enzyme levels (as defined ≥ULN in ALT, AST, Bilirubin and Alkaline Phosphatase levels) at time of enrollment
✕. . 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.