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

Locations

3
Wuhan Union Hospital WuhanHubei, China
Tianjin Institute of Hematology TianjinTianjin Municipality, China
The First Affiliated Hospital of Zhejiang University HangzhouZhejiang, China

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