BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
Purpose
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
- Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental B-cell activating factor receptor-Chimeric antigen receptor T cells [BAFFR-CAR T cells] |
BAFFR-CAR T cells in participants with r/r B-NHL |
|
Recruiting Locations
University of Kansas Hospital
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
More Details
- Status
- Recruiting
- Sponsor
- PeproMene Bio, Inc.
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.