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
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