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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

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

    Drug

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

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

The number and severity of dose-limiting toxicity (DLT) events

Time frame
Within 28 Days After BRL-201 Infusion
2

AEs

The total number, incidence, and severity of AEs

Time frame
Up to 24 Months After BRL-201 Infusion
3

RP2D

The recommended phase 2 dose

Time frame
Within 28 Days After BRL-201 Infusion

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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