OncoMatch/Clinical Trials/NCT06191887
B-Cell Activating Factor Receptor (BAFFR)-Based Chimeric Antigen Receptor T-Cells With Fludarabine and Cyclophosphamide Lymphodepletion for the Treatment of Relapsed or Refractory B-cell Hematologic Malignancies
Is NCT06191887 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Autologous BAFFR-targeting CAR T Cells and Bendamustine for b-cell non-hodgkin lymphoma.
Treatment: Autologous BAFFR-targeting CAR T Cells · Bendamustine · Cyclophosphamide · Fludarabine — This phase I trial tests safety, side effects and best dose of B-cell activating factor receptor (BAFFR)-based chimeric antigen receptor T-cells, with fludarabine and cyclophosphamide lymphodepletion, for the treatment of patients with B-cell hematologic malignancies that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). BAFFR-based chimeric antigen receptor T-cells is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving chemotherapy, such as fludarabine and cyclophosphamide, helps ill cancer cells in the body and helps prepare the body to receive the BAFFR based chimeric antigen receptor T-cells. Giving BAFFR based chimeric antigen receptor T-cells with fludarabine and cyclophosphamide for lymphodepletion may work better for the treatment of patients with relapsed or refractory B-cell hematologic malignancies.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: TNFRSF13C overexpression (Positive BAFFR test)
REGISTRATION: Positive BAFFR test
Required: CD19 expression (CD19+ B cell malignancies)
For CD19+ B cell malignancies
Allowed: BTK resistance mutation
Exception: Patients in stable disease (SD) or partial response (PR) with a known ibrutinib resistance mutation (BTK or phospholipase Cγ2) may be included even if on ibrutinib therapy for less than 6 months
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: BTK inhibitor (ibrutinib, acalabrutinib, zanubrutinib) — CLL/SLL
For CLL/SLL, patients must have received ≥ two prior lines of therapy, and/or ≥ 6 months of second line prior BTK inhibition (e.g. ibrutinib or other such as acalabrutinib or zanubrutinib) and must have failed to respond to venetoclax or be intolerant.
Must have received: antibody directed against CD20 — CLL/SLL, FL, MCL, MZL, LBCL, Richter's Transformation
including an antibody directed against CD20
Must have received: BTK inhibitor — MCL
For Mantle Cell Lymphoma, patients must have received ≥ two prior lines of therapy, including an antibody directed against CD20, and a BTK inhibitor.
Cannot have received: anti-BAFF-R therapy
PRE-REGISTRATION: Prior anti-BAFF-R therapies
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL (unless due to documented marrow involvement with disease); ANC ≥ 1500/mm^3 (unless due to documented marrow involvement with disease); Platelet count ≥100,000/mm^3 (unless due to documented marrow involvement with disease)
Kidney function
Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula
Liver function
Total bilirubin ≤ 1.5 x ULN (≤ 3.0 x ULN for Gilbert's Syndrome and direct bilirubin ≤ 1.5 x ULN); ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Cardiac function
Ejection fraction (EF) of ≥ 45%
Hemoglobin ≥ 9.0 g/dL (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration; Absolute neutrophil count (ANC) ≥ 1500/mm^3 (unless due to documented marrow involvement with disease) obtained ≤14 days prior to registration; Platelet count ≥100,000/mm^3 (unless due to documented marrow involvement with disease) obtained ≤ 14 days prior to registration; Total bilirubin ≤ 1.5 x ULN (Subjects with Gilbert's Syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) obtained ≤ 14 days prior to registration; Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) obtained ≤ 14 days prior to registration; Calculated creatinine clearance ≥45 ml/min using the Cockcroft-Gault formula obtained ≤ 14 days prior to registration; Patients must have an ejection fraction (EF) of ≥ 45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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