The Safety and Efficacy of BRL-201 in the Treatment of r/r B Lymphocyte Non-Hodgkin Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBioray Laboratories

About this trial

This is a multi-center, single-arm, open-label clinical study, and the sample size is set to 12-18 subjects.

Eligibility criteria

Qualifiers

Willing to participate in this clinical study and sign an informed consent form;

Age ≥ 18 years old;

Estimated survival time ≥ 3 months;

Presence of at least one measurable lesion as assessed according to Lugano Classification 2014 for response assessment in lymphomas (i.e., the cross-sectional images obtained by CT show that the long diameter of lymph node lesions is > 15 mm or the long diameter of extranodal lesions is > 10 mm, and FDG-PET scan results are positive). Lesions, for which radiotherapy was provided, can be regarded as measurable lesions only if there is an unequivocal progression after radiotherapy;

Disqualifiers

Pregnant or lactating women;

Subjects who previously received allogeneic cell therapies, including allogeneic stem cell transplant;

Subjects who previously received anti-CD19 targeted therapy, except those who receive BRL-201 and are eligible to receive reinfusion in this study;

Prior treatment with any CAR-T cell product or other genetically modified T cell therapies;

Trial design

Treatments tested in this trial

  • CD19-targeted non-viral PD1 site-specific integrated CAR-T cell injection

Treatment groups

18 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bioray Laboratories

Lead sponsor

Chinese Academy of Medical Sciences

Collaborator

Zhejiang University

Collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Collaborator