A Study of LUCAR-20SP in Subjects with Relapsed/refractory B-cell Non-Hodgkin Lymphoma
- Conditions
- Relapsed B-cell Non-Hodgkin LymphomaRefractory B-cell Non-Hodgkin Lymphoma
- Interventions
- Registration Number
- NCT06313957
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Each subject will receive LUCAR-20SP cells LUCAR-20SP cells Chimeric antigen receptor T cells LUCAR-20SP cells
- Primary Outcome Measures
Name Time Method Pharmacokinetics in bone marrow Minimum 2 years after LUCAR-20SP infusion (Day 1) CAR positive T cells levels in bone marrow after LUCAR-20SP infusion. CAR transgene levels in bone marrow after LUCAR-20SP infusion.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) Minimum 2 years after LUCAR-20SP infusion (Day 1) 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.
Recommended Phase 2 Dose (RP2D) regimen finding Minimum 2 years after LUCAR-20SP infusion (Day 1) RP2D established through accelerated titration design (ATD) and Bayesian Optimal Interval (BOIN) design.
Pharmacokinetics in peripheral blood Minimum 2 years after LUCAR-20SP infusion (Day 1) CAR transgene levels in peripheral blood after LUCAR-20SP infusion. CAR positive T cells levels in bone marrow after LUCAR-20SP infusion.
Dose-limiting toxicity (DLT) rate Minimum 2 years after LUCAR-20SP infusion (Day 1) 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.
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) after administration Minimum 2 years after LUCAR-20SP infusion (Day 1) ORR is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment via LUCAR-20SP cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per the Lugano Classification for Initial Evaluation, Staging, and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma (Lugano 2014)
Duration of Remission (DoR) after administration Minimum 2 years after LUCAR-20SP infusion (Day 1) DoR is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to Lugano 2014) of the responders (who achieve PR or better response).
Overall Survival (OS) after administration Minimum 2 years after LUCAR-20SP infusion (Day 1)] OS is defined as the time from the date of first infusion of LUCAR-20SP to death of the subject.
Progression-free Survival (PFS) after administration Minimum 2 years after LUCAR-20SP infusion (Day 1)] PFS is defined as the time from the date of first infusion of the LUCAR-20SP to the first documented disease progression (according to Lugano 2014) or death (due to any cause), whichever occurs first.
Incidence of anti-LUCAR-20SP antibody Minimum 2 years after LUCAR-20SP infusion (Day 1) The incidence of anti-LUCAR-20SP antibody in patients who received LUCAR-20SP infusion.
Time to Response (TTR) after administration Minimum 2 years after LUCAR-20SP infusion (Day 1) TTR is defined as the time from the date of first infusion of LUCAR-20SP to the date of the first response evaluation of the subject who has met all criteria for PR or better.
Trial Locations
- Locations (3)
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Beijing GoBroad Boren Hospital
🇨🇳Beijing, Beijing, China
Peking University Cancer Hospital & Institute
🇨🇳Beijing, Beijing, China
Henan Cancer Hospital🇨🇳Zhengzhou, ChinaKeshu ZhouContact13674902391drzhouks77@163.com