An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed or Refractory (R/R) LBCL

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥18 years old;

• Sign on the informed consent;

• Subjects must have histologically confirmed Large B-cell Lymphoma;

• Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy including autologous hematopoietic stem cell transplantation(auto-HSCT);

• Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;

• Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;

• Adequate organ function;

• Adequate vascular access for leukapheresis procedure;

• Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;

⁃ Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;

⁃ Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.

Locations
Other Locations
China
Tianjin Cancer Hospital
RECRUITING
Tianjin
Contact Information
Primary
Relma-cel Medical
JWCAR029Medical@jwtherapeutics.com
+86 21 50464201
Time Frame
Start Date: 2024-08-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Relma-cel
Efficacy, safety and PK of Relma-cel will be evaluated in 1 x 10\^8 CAR+T cells dose level
Related Therapeutic Areas
Sponsors
Leads: Shanghai Ming Ju Biotechnology Co., Ltd.

This content was sourced from clinicaltrials.gov

Similar Clinical Trials