BAFF‑R CAR‑T treatment for adults with CD19‑negative relapsed or refractory B‑cell lymphoma

A Prospective, Open-label and Single-arm Study of BAFF-R CAR-T Cells in Adult Subjects With CD19-Negative Relapsed or Refractory B-Cell Lymphoma

This trial will see if BAFF‑R CAR‑T cells are safe and tolerable for adults whose B‑cell lymphoma has returned or not responded and is CD19‑negative.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Suzhou)
• Trial ID: NCT07369492 on ClinicalTrials.gov

What this trial studies

This is a prospective, open‑label, single‑arm Phase 1 dose‑escalation trial in adult patients with CD19‑negative relapsed or refractory B‑cell lymphoma whose tumors express BAFF‑R. Participants will receive autologous BAFF‑R CAR‑T cells across planned dose levels (1.0×10^6, 3.0×10^6, 9.0×10^6 CAR+ T cells/kg, with a specified maximum cell dose) to define safety and the maximum tolerated dose. Key objectives include safety, tolerability, determination of a recommended Phase II dose, and exploratory measures of efficacy, pharmacokinetics, and CAR‑T cell persistence. The trial is single‑centered at Suzhou Hongci Hematology Hospital with protocolized follow‑up for adverse events and response assessments.

Who should consider this trial

Good fit: Adults with CD19‑negative relapsed or refractory B‑cell lymphoma whose tumor cells express BAFF‑R, with ECOG ≤2, adequate organ function, expected survival of at least 3 months, and meeting the specified prior‑therapy criteria are ideal candidates.

Not a fit: Patients whose tumors do not express BAFF‑R, who are medically unfit, or who have very limited life expectancy are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option for patients with CD19‑negative B‑cell lymphoma who have few effective therapies.

How similar studies have performed: CD19‑directed CAR‑T therapies have demonstrated strong efficacy in B‑cell lymphoma, but BAFF‑R–targeted CAR‑T is a newer strategy with limited clinical data to date.

Eligibility criteria

Inclusion Criteria:

* 1\. Subjects voluntarily participate in clinical research and sign informed consent.
* 2\. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) 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; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation).
* 3\. Expected survival ≥ 3 months.
* 4\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry.
* 5\. ECOG score ≤ 2.
* 6\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values:
* Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m²
* Hepatic function: Serum alanine aminotransferase (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.
* 7\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA).
* 8\. Adequate bone-marrow reserve without blood transfusion as defined by:
* Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L.
* Absolute lymphocyte count (ALC) ≥ 0.1 x 10\^9/L.
* Platelets ≥ 50 x 10\^9/L.
* Hemoglobin \>80g/L.
* 9\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy.

Exclusion Criteria:

* 1\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months.
* 2\. Infectious disease(HIV, Active Tuberculosis ect.).
* 3\. Active infection: hepatitis B, hepatitis C.
* 4\. Abnormal vital signs or refuse to receive examination.
* 5\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment.
* 6\. History of severe hypersensitivity or known hypersensitivity to IL-2.
* 7\. Systemic or local severe infection requiring antimicrobial therapy.
* 8\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.

Where this trial is running

Suzhou

• Suzhou Hongci Hematology Hospital — Suzhou, China (Recruiting)

Study contacts

• Study coordinator: Xiao Ma

Conditions B-cell Lymphoma