About this trial
This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety and tolerability of SL1617 Injection in patients with relapsed or refractory B-cell lymphoma. SL1617 is an investigational in vivo CAR T-cell immunotherapy targeting CD19 and CD20, utilizing an engineered lentiviral vector to generate functional CAR-T cells in vivo without the need for ex vivo cell processing or lymphodepletion. Participants will receive a single intravenous infusion of SL1617 using a traditional 3+3 dose-escalation design. The planned starting dose is 1.0 × 10\^9 transducing units (TU), followed by dose levels of 3.0 × 10\^9 TU and 6.0 × 10\^9 TU. Dose escalation will be guided by the occurrence of dose-limiting toxicities (DLTs).
Eligibility criteria
Qualifiers
1. The subject voluntarily agrees to participate in the study, has signed the informed consent form, and is willing and able to comply with the scheduled visits, study treatment, laboratory tests, and other study procedures.
Lymphoma cells are confirmed to express CD19 and/or CD20 antigens by immunophenotyping or immunohistochemical examination.
Aggressive B-cell lymphomas, including large B-cell lymphoma (LBCL), Burkitt lymphoma (BL), and mantle cell lymphoma (MCL);
Indolent B-cell lymphomas, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma (LPL), and hairy cell leukemia (HCL).
Disqualifiers
1. The patient has severe cardiac dysfunction, or left ventricular ejection fraction (LVEF) <50%, or a history within the 12 months prior to enrollment of myocardial infarction, coronary angioplasty or coronary stent implantation, unstable angina, clinically significant arrhythmia, or other severe cardiovascular diseases.
Trial design
Treatments tested in this trial
- SL1617 Injection
Treatment groups
Sponsors and collaborators
Chinese PLA General Hospital
Lead sponsor
Hebei Senlang Biotechnology Inc., Ltd.
Collaborator