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NCT05370430 | RECRUITING | Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-NHL
Sponsor:

Pepromene Bio, Inc.

Brief Summary:

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

Condition or disease

Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma

Intervention/treatment

BAFFR-CAR T cells

Phase

PHASE1

Detailed Description:

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Non-Hodgkin's Lymphoma (B-NHL) 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 36 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
Actual Study Start Date : 2022-06-13
Estimated Primary Completion Date : 2027-07-13
Estimated Study Completion Date : 2028-06-13

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Informed Consent: Signed informed consent by the participant or legally authorized representative.
  • 2. Age \& Performance Status
    • * Age ≥ 18 years
    • * ECOG performance status ≤ 2
    • 3. Diagnosis \& Disease Criteria
      • * Histologically confirmed B-NHL, including LBCL, MCL, and FL/MZL subtypes meeting specified prior treatment conditions.
      • * BAFF-R expression on lymphoma cells required.
      • 4. Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
      • 5. Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \< 5% before leukapheresis.
      • 6. Organ Function \& Laboratory Criteria
        • * Hematologic: ANC ≥ 1000/μL, Platelets ≥ 75,000/μL (exceptions for BM involvement).
        • * Liver Function: Bilirubin ≤ 1.5x ULN (except Gilbert's), AST/ALT \< 3x ULN.
        • * Renal Function: CrCl ≥ 50 mL/min.
        • * Cardiac \& Pulmonary: LVEF ≥ 45%, QTcF ≤ 480 ms, O₂ saturation \> 91% on room air.
        • 7. Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).
        • 8. Reproductive Considerations
          • * Negative pregnancy test for females of childbearing potential.
          • * Use of effective contraception or abstinence through 3 months post-treatment.
          Exclusion Criteria
          • 1. Prior Therapies \& Transplants
            • * Prior allogeneic SCT.
            • * Autologous SCT \< 6 months before leukapheresis.
            • * Concurrent systemic steroids or chronic immunosuppressant use.
            • 2. Disease-Specific Exclusions
              • * Cardiac lymphoma involvement.
              • * Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).
              • 3. Medical Conditions
                • * Active autoimmune disease requiring immunosuppressants.
                • * Primary immunodeficiency.
                • * Cardiac conditions, including NYHA Class III/IV heart disease, arrhythmia, recent MI (≤ 6 months), stroke (≤ 6 months), or significant VTE (≤ 6 months).
                • * Neurologic conditions, including prior optic neuritis, CNS inflammatory diseases, or seizure disorders.
                • * History of malignancy, unless resected/treated with curative intent or in remission for ≥ 3 years.
                • * Uncontrolled systemic infections or active CNS lymphoma.
                • 4. Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
                • 5. Other Considerations
                  • * Investigator-determined safety concerns.
                  • * Potential noncompliance with study procedures.
BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-NHL

Location Details

NCT05370430

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope Medical Center

Duarte, California, United States, 91010

RECRUITING

United States, Minnesota

The University of Minnesota

Minneapolis, Minnesota, United States, 55455

RECRUITING

United States, North Carolina

Atrium Health Levine Cancer Institute - Morehead

Charlotte, North Carolina, United States, 28204

RECRUITING

United States, Washington

Providence Swedish Cancer Institute

Seattle, Washington, United States, 98104