A Study of LUCAR-20SP in Subjects with Relapsed/refractory B-cell Non-Hodgkin Lymphoma

Peking University Cancer Hospital & Institute

Status and phase

Enrolling

Phase 1

Conditions

Relapsed B-cell Non-Hodgkin Lymphoma

Refractory B-cell Non-Hodgkin Lymphoma

Treatments

Biological: LUCAR-20SP cells

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06313957

LB2302-0001

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.