OncoMatch/Clinical Trials/NCT07369492
Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma
Is NCT07369492 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BAFF-R CAR-T cells for b-cell lymphoma.
Treatment: BAFF-R CAR-T cells — The purpose of this study is to evaluate the safety and tolerability of BAFF-R CAR-T Cells in Adult Subjects with CD19-Negative relapsed or refractory B-Cell Lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 negative (negative)
CD19-negative relapsed or refractory B-cell lymphoma
Required: TNFRSF13C overexpression
BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy — first-line
failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months
Must have received: systemic therapy — second-line
not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation)
Lab requirements
Blood counts
ANC ≥ 1 x 10^9/L; ALC ≥ 0.1 x 10^9/L; Platelets ≥ 50 x 10^9/L; Hemoglobin >80g/L
Kidney function
serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL/min/1.73 m²
Liver function
ALT ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included.
Cardiac function
Stable hemodynamics and LVEF ≥ 45% assessed by echocardiography or MUGA
Subjects with adequate organ functions prior to enrollment, meet the following laboratory values: Renal function: serum creatinine ≤ 1.5 × ULN or eGFR ≥ 60 mL/min/1.73 m²; Hepatic function: ALT ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included. Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation >95% on room air. Stable hemodynamics and LVEF ≥ 45% assessed by echocardiography or MUGA. Adequate bone-marrow reserve without blood transfusion as defined by: ANC ≥ 1 x 10^9/L; ALC ≥ 0.1 x 10^9/L; Platelets ≥ 50 x 10^9/L; Hemoglobin >80g/L.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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