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

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.

Eligibility

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.

Conditions3

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