A Study of LUCAR-20SP in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LUCAR-20SP cells.
- Who it may be relevant to
- Registry conditions: Relapsed B-cell Non-Hodgkin Lymphoma, Refractory B-cell Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LUCAR-20SP, an Allogenic Chimeric Antigen Receptor(CAR)-T Cell Therapy Targeting CD20 in Subjects With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Overview
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.
Interventions
- Biological LUCAR-20SP cells
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Primary outcome measures
- Dose-limiting toxicity (DLT) rate [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Incidence, severity, and type of treatment-emergent adverse events (TEAEs) [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Recommended Phase 2 Dose (RP2D) regimen finding [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Pharmacokinetics in peripheral blood [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Pharmacokinetics in bone marrow [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Secondary outcome measures (6)
- Objective Response Rate (ORR) after administration [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Time to Response (TTR) after administration [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Duration of Remission (DoR) after administration [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
- Progression-free Survival (PFS) after administration [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]]
- Overall Survival (OS) after administration [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]]
- Incidence of anti-LUCAR-20SP antibody [Time frame: Minimum 2 years after LUCAR-20SP infusion (Day 1)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Beijing GoBroad Boren Hospital — Beijing
- Peking University Cancer Hospital & Institute — Beijing
- Henan Cancer Hospital — Zhengzhou
Identifiers
NCT: NCT06313957 · LB2302-0001