A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
PeproMene Bio, Inc.
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)
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 a…
Interventions
- 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
Locations (6)
- City of Hope Medical CenterDuarte, California
- Stanford UniversityStanford, California
- University of Kansas HospitalKansas City, Kansas
- University of MinnesotaMinneapolis, Minnesota
- Atrium Health Levine Cancer Institute - MoreheadCharlotte, North Carolina
- Providence Swedish Cancer InstituteSeattle, Washington