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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Suzhou Hongci Hematology Hospital
  Suzhou, China Recruiting

Study contacts

• Study coordinator: Xiao Ma
• Email: colleenld2020@hotmail.com
• Phone: 0512-83837999

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Bendamustine vs standard lymphodepletion before CAR-T in LBCL

  This trial tests whether bendamustine can replace the standard bendamustine-free lymphodepletion before CAR-T therapy in adults with large B-cell lymphoma who have had prior treatment.

  Recruiting at 8 sites Phase 2 Swiss Cancer Institute · Aarau and 8 other locations · NCT07593482

• CD5 CAR T-cell therapy for relapsed or refractory T-cell lymphoma

  This trial tries CD5 CAR T-cell therapy, using either the patient's own cells or donor cells, and may bridge to stem-cell transplant for people 14–70 with relapsed or refractory T-cell lymphoma.

  Recruiting at 3 sites Phase 1/2 Beijing GoBroad Hospital · Beijing and 2 other locations · NCT07022964

• BCOR and ZC3H12 knockout CD19 CAR-T therapy for relapsed/refractory B‑cell lymphoma

  This will try an autologous CD19 CAR‑T treatment with two genes (BCOR and ZC3H12) turned off to see if it works better for adults whose B‑cell lymphoma has returned or not responded to prior treatments.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07009002

• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

  This trial tests whether the antibody drug glofitamab given with obinutuzumab can shrink or control mantle cell lymphoma that returned or didn't respond after CD19 CAR‑T therapy in adults.

  Recruiting at 11 sites Phase 2 National Cancer Institute (NCI) · Duarte, California and 10 other locations · NCT07003295

• Allogeneic CD19/BCMA CAR-T for relapsed or refractory B-cell and plasma cell cancers

  This study will test whether an off-the-shelf CAR-T product (RN1101) that targets CD19 and BCMA can help people with relapsed or refractory B-cell lymphomas and multiple myeloma.

  Recruiting Early Phase 1 Affiliated Hospital of Jiangsu University · Zhenjiang, Jiangsu · NCT06976437

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.