A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
RECRUITINGStanford University
Stanford, California, United States
RECRUITINGUniversity of Kansas Hospital
Kansas City, Kansas, United States
Incidence of adverse events
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.
Time frame: Up to 1 year post treatment
Maximum Tolerated Dose (MTD)
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.
Time frame: The DLT evaluation period is defined as 28 days following BAFFR CAR-T infusion.
Disease Response
Defined as achieving a best response of complete response or partial response per Lugano Criteria
Time frame: Up to 1 year post treatment
Minimal Residual Disease (MRD)
Negative MRD is defined by malignant cells \< 0.01% by flow cytometry or clonoSEQ.
Time frame: Up to 1 year post treatment
B Cell Quantification
Measured by flow cytometry
Time frame: Up to 1 year post treatment
Progression-free survival (PFS)
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate PFS.
Time frame: From CAR T cell infusion to the first observation of disease relapse/progression or death from any cause, whichever occurs first, assessed up to 15 years.
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University of Minnesota
Minneapolis, Minnesota, United States
RECRUITINGAtrium Health Levine Cancer Institute - Morehead
Charlotte, North Carolina, United States
RECRUITINGProvidence Swedish Cancer Institute
Seattle, Washington, United States
RECRUITINGOverall Survival (OS)
Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate OS.
Time frame: From the day of BAFFR-CAR T cell infusion to death from any cause assessed, up to 15 years.