Clinical trial
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
Name
LB2302-0001
Description
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.
Trial arms
Trial start
2024-03-01
Estimated PCD
2026-09-01
Trial end
2028-09-01
Status
Recruiting
Phase
Early phase I
Treatment
LUCAR-20SP cells
Prior to infusion of the LUCAR-20SP, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Arms:
Each subject will receive LUCAR-20SP cells
Size
42
Primary endpoint
Dose-limiting toxicity (DLT) rate
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in peripheral blood
Minimum 2 years after LUCAR-20SP infusion (Day 1)
Pharmacokinetics in bone marrow
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}
Updated at
2024-03-15
1 organization
1 product
1 indication
Organization
Peking University Cancer Hospital & InstituteProduct
LUCAR-20SPIndication
B-cell non-Hodgkin lymphoma