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RECRUITINGPhase 1INTERVENTIONAL

Safety and Efficacy Study of BAFF-R CAR-T Cells in Adult Subjects 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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. Subjects voluntarily participate in clinical research and sign willing to sign a consent form. - 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 your organs (liver, kidneys, etc.) are working well enough based on blood testss 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. - platelet count at least 50 x 10\^9/L. - Hemoglobin \>80g/L. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BIOLOGICAL

BAFF-R CAR-T cells

BAFF-R CAR-T cells, single intravenous infusion

Locations (1)

Suzhou Hongci Hematology Hospital
Suzhou, China