NCT05370430 · PeproMene Bio, Inc.
BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
What this study is about
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
View original scientific description
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
Interventions
BIOLOGICAL
BAFFR-CAR T cells
First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL
Primary outcome measures
Incidence of adverse events
Time frame: Up to 1 year post treatment
Assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B-cell Non-Hodgkin's Lymphoma (B-NHL) and it's subtypes. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.
Maximum Tolerated Dose (MTD)
Time frame: The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.
Determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BAFFR-CAR T cells. The highest dose with ≤ 1/6 participants with DLT will be considered the MTD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Informed Consent: Signed informed consent by the participant or legally authorized representative.
- Age \& Performance Status:
- Age ≥ 18 years
- ECOG performance status ≤ 2
- 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.
- Measurable Disease: Tumor ≥1.5 cm on CT/PET scan or evidence of disease in blood, BM, GI, skin, or spleen.
- Prior CAR T-cell Therapy: Allowed if ≥ 3 months since last treatment and CD19 CAR-T persistence \< 5% before leukapheresis.
- 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.
- Infectious Disease Screening: Seronegative for HIV, active HBV, active HCV (or undetectable viral load if positive).
- 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.
- Disease-Specific Exclusions:
- Cardiac lymphoma involvement.
- Need for urgent therapy due to tumor-related complications (e.g., bowel obstruction).
- 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.
- Pregnancy \& Breastfeeding: Females who are pregnant or nursing.
- Other Considerations:
- Investigator-determined safety concerns.
- Potential noncompliance with study procedures.
Where
- Duarte, California
- Stanford, California
- Kansas City, Kansas
- Minneapolis, Minnesota
- Charlotte, North Carolina
- Seattle, Washington
Collaborators
City of Hope Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 20, 2025 · Source of record for eligibility and locations