NCT05370430 BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
| NCT ID | NCT05370430 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | PeproMene Bio, Inc. |
| Condition | Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2022-06-13 |
| Primary Completion | 2027-07-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2022-06-13 with a primary completion date of 2027-07-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility 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.
Contact & Investigator
Elizabeth Budde, MD
STUDY CHAIR
City of Hope Medical Center
Frequently Asked Questions
Who can join the NCT05370430 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05370430 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05370430 currently recruiting?
Yes, NCT05370430 is actively recruiting participants. Contact the research team at hazel.cheng@pepromenebio.com for enrollment information.
Where is the NCT05370430 trial being conducted?
This trial is being conducted at Duarte, United States, Stanford, United States, Kansas City, United States, Minneapolis, United States and 2 additional locations.
Who is sponsoring the NCT05370430 clinical trial?
NCT05370430 is sponsored by PeproMene Bio, Inc.. The principal investigator is Elizabeth Budde, MD at City of Hope Medical Center. The trial plans to enroll 36 participants.