Tests BAFFR-targeting CAR T cells in adults with returning B-cell lymphoma
Tests modified immune cells targeting BAFFR in adults with lymphoma that returned.
Plain-language title generated from the registry record
Registry title: BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL
Key facts
- Where
- Duarte, Kansas City, Minneapolis, Seattle, and Stanford, United StatesSee the 5 sites
- Phase
- Phase 1
Where in United States
- City of Hope Medical CenterDuarte, United StatesTaking people
- University of Kansas HospitalKansas City, United StatesTaking people
- University of MinnesotaMinneapolis, United StatesTaking people
- Providence Swedish Cancer InstituteSeattle, United StatesTaking people
- Stanford UniversityStanford, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- PeproMene Bio, Inc.
- Trial code
- NCT05370430
- Record updated
- 10 November 2026
- Original 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)Read full original descriptionShow less
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
Inclusion: 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: 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.