The aim of this study is to analyze the safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma and explore the Maximum Tolerated Dose (MTD).
The secondary objective of this study is to explore the efficacy of BAFF-R CAR-T in participants with relapsed/refractory BAFF-R-positive B-cell lymphoma.
The study also aims to explore the pharmacokinetic characteristics of BAFF-R CAR-T in vivo and the impact of BAFF-R CAR-T on lymphocyte subsets in vivo.
:Relapsed and refractory (R/R) mantle cell lymphoma (MCL):Histologically confirmed MCL;Relapsed or refractory after at least 2 lines of prior treatment (including anti-CD20 monoclonal antibody and Bruton's tyrosine kinase inhibitor [BTKi]).
:Relapsed and refractory (R/R) chronic lymphocytic leukemia (CLL):Histologically confirmed CLL;Patients who have received at least immunochemotherapy and are refractory to both BTK inhibitors and B-cell lymphoma 2 (BCL2) inhibitors.
:Relapsed and refractory (R/R) diffuse large B-cell lymphoma (DLBCL):Histologically confirmed DLBCL;Patients who have received anthracycline-based therapy and anti-CD20 monoclonal antibody therapy, and have undergone at least 2 lines of treatment in total; or patients who failed to achieve remission, progressed, or relapsed within 12 months after initial standard treatment.
:Relapsed and refractory (R/R) follicular lymphoma (FL):Histologically confirmed FL (Grade 1-3a);Patients who have received anti-CD20 monoclonal antibody-containing therapy and have undergone at least 2 lines of treatment in total; or patients who relapsed within 24 months after initial treatment.
Patients with a history of allergy to any component of the cellular product.
Patients with acute graft-versus-host disease (aGVHD) graded as Grade II-IV according to the Glucksberg criteria, or with severity graded as Grade B-D according to the IBMTR index; patients with acute or chronic graft-versus-host disease (cGVHD) requiring systemic treatment within 4 weeks prior to enrollment.
Participants who have received a live vaccine injection within 4 weeks prior to enrollment.
Patients with central nervous system (CNS) diseases unrelated to lymphoma central nervous system involvement (e.g., cerebral aneurysm, epilepsy, stroke, Alzheimer's disease, psychiatric disorders, etc.). Lymphoma central nervous system involvement or gastrointestinal tract involvement is not an exclusion criterion, but eligibility for enrollment shall be determined by the investigator.
Single group
BAFF-R CAR-T
DrugEligible participants should receive preconditioning 5 to 3 days prior to CAR-T cell infusion. The recommended preconditioning regimen is fludarabine (30 mg/m²/day for 3 days) and cyclophosphamide (300 mg/m²/day for 3 days) (Flu/Cy). Thirty minutes before the infusion, medications for preventing allergic reactions should be administered: 25 mg of promethazine hydrochloride or 12.5 mg of diphenhydramine, which can be given via intramuscular injection or oral administration. In Phase1 bispecific maintenance therapy will be divided into three dose groups, using a "3 + 3" dose escalation design. In Phase 2, the Maximum Tolerated Dose (MTD) identified in Phase 1 will be used, and the study will be expanded to enroll 20 participants.
Evaluation of the Safety of BAFF-R Chimeric Antigen Receptor T-Cell Injection (BAFF-R CAR-T) in Subjects with Relapsed and Refractory BAFF-R-Positive B-Cell Lymphoma, and Exploration of the Maximum Tolerated Dose (MTD)
The possible adverse reactions recorded in each item were evaluated. The highest dose at which fewer than 2 out of 6 subjects (i.e., \< 2/6) experience Dose-Limiting Toxicity (DLT) (with at least 6 subjects in this dose group having received BAFF-R CAR-T infusion and completed the DLT observation period).
Objective response rates (ORR)
Overall survival (OS)
Progression-free survival (PFS)
Complete remission rate (CRR)
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
Hebei Taihe Chunyu Biotechnology Co., Ltd
Collaborator
