A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
NCT06313957 · Phase 1 · Beijing, Beijing Municipality, China
- Condition
- Lymphoma
- Disease stage
- Stage I-IV
- Phase
- Phase 1
- Study type
- BIOLOGICAL
- Intervention
- LUCAR-20SP cells
- Age
- 18 Years to
- Gender
- All
- Sponsor
- Peking University Cancer Hospital & Institute
- Research institution
- Peking University Cancer Hospital & Institute
- Facility
- Beijing GoBroad Boren Hospital
- Research center
- Beijing GoBroad Boren Hospital
Summary
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.
Detailed description
This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor efficacy profiles of LUCAR-20SP, an allogenic CAR-T cell therapy in subjects with relapsed/refractory B-cell non-Hodgkin lymphoma. Patients who meet the eligibility criteria will receive LUCAR-20SP infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment and follow-up.
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.
Primary outcomes
Dose-limiting toxicity (DLT) rate; Incidence, severity, and type of treatment-emergent adverse events (TEAEs); Recommended Phase 2 Dose (RP2D) regimen finding
Secondary outcomes
Objective Response Rate (ORR) after administration; Time to Response (TTR) after administration; Duration of Remission (DoR) after administration