CELL INTELLIGENCE · 肿瘤细胞治疗研究

Inclusion Criteria:

* Subjects voluntarily participate in clinical research;
* Age ≥18 years old;
* Eastern Cooperative Oncology Group (ECOG) score 0-1;
* Histologically confirmed large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, histologically indolent lymphoma to diffuse large B-cell lymphoma; CD20 positive;
* At least one measurable tumor lesion according to the Lugano 2014.
* Expected survival ≥3 months;
* Clinical laboratory values in the screening period meet criteria.
* Effective contraception.

Exclusion Criteria:

* Prior antitumor therapy with insufficient washout period.
* Previous treatment with allogeneic cell and gene therapy (such as CAR-T); Except subjects with evidence that previous allogeneic cell and gene therapy products (such as CAR-positive T cells and CAR transgenes) in the subject have been below the lower limit of detection;
* Previously received allogeneic hematopoietic stem cell transplantation;
* Previously received gene therapy;
* Donor specific antibody (DSA) positive subjects will be excluded;
* Severe underlying diseases;
* Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C virus ribonucleic acid (HCV RNA) or human immunodeficiency virus antibody (HIV-Ab) positive;
* Presence of other serious pre-existing medical conditions that may limit patient participation in the study. Any condition that, in the investigator's judgment, will make the subject unsuitable for participation in this study.

主要终点：Dose-limiting toxicity (DLT) rate · DLT refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose. · Minimum 2 years after LUCAR-20SP infusion (Day 1)；Incidence, severity, and type of treatment-emergent adverse events (TEAEs) · An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment. · Minimum 2 years after LUCAR-20SP infusion (Day 1)；Recommended Phase 2 Dose (RP2D) regimen finding · RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design. · Minimum 2 years after LUCAR-20SP infusion (Day 1)；Pharmacokinetics in peripheral blood · CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. · Minimum 2 years after LUCAR-20SP infusion (Day 1)；Pharmacokinetics in bone marrow · CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion. · Minimum 2 years after LUCAR-20SP infusion (Day 1)
次要终点：Objective Response Rate (ORR) after administration；Time to Response (TTR) after administration；Duration of Remission (DoR) after administration；Progression-free Survival (PFS) after administration；Overall Survival (OS) after administration；Incidence of anti-LUCAR-20SP antibody

• Each subject will receive LUCAR-20SP cells · EXPERIMENTAL · Chimeric antigen receptor T cells LUCAR-20SP cells

This is a prospective, single-arm, open-label, exploratory clinical study of LUCAR-20SP in adult subjects with relapsed/refractory B-cell non-Hodgkin lymphoma.