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 (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT07369492 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received systemic therapy and systemic therapy.
Does this trial require CD19?
Yes, CD19 negative is a required biomarker for enrollment.
Does this trial require TNFRSF13C?
Yes, TNFRSF13C overexpression is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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