RecruitingPhase 1NCT05370430

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory 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)

Sponsor

PeproMene Bio, Inc.

Enrollment

36 participants

Start Date

Jun 13, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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.

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.

BIOLOGICALBAFFR-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

City of Hope Medical Center

Duarte, California, United States

Stanford University

Stanford, California, United States

University of Kansas Hospital

Kansas City, Kansas, United States

University of Minnesota

Minneapolis, Minnesota, United States

Atrium Health Levine Cancer Institute - Morehead

Charlotte, North Carolina, United States

Providence Swedish Cancer Institute

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT05370430