NCT06655519

An Exploratory Study of RD140 Injection in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

An Exploratory Study of Fully Human Anti-B-Cell Maturation Antigen (BCMA)/G Protein-coupled Receptor, Class C Group 5 Member (GPRC5D) Chimeric Antigen Receptor T Cells (RD140) in Patients With Relapsed/Refractory Multiple Myeloma or Plasma Cell Leukemia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Peking University People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, open clinical study, divided into two phases of dose escalation and dose expansion, to observe the safety and efficacy of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma or plasmacytic leukemia.

Detailed description

This study is divided into two stages: dose escalation and dose extension. The "3+3" dose escalation design was adopted in the dose escalation stage, and three dose escalation dose groups of 1.0×10\^5 CART(Chimeric Antigen Receptor T Cell) cells/kg, 3.0×10\^5 CART cells/kg and 6.0×10\^5 CART cells/kg were preset. Each dose group level included 3-6 subjects with a single dose. The objective is to preliminarily observe the safety and tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of RD140 injection at different doses in patients with relapsed/refractory multiple myeloma (RRMM) or plasma cell leukemia, and provide evidence for dose expansion phase. In the dose expansion phase, 1 to 2 dose groups were selected for expansion based on the dose escalation phase, and 3 to 6 subjects were included in each extended dose group to further evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of RD140 injection in the treatment of RRMM or plasma cell leukemia.

Conditions

• Relapsed/Refractory Multiple Myeloma
• Plasma Cell Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T（RD140 injection）	This study is divided into two stages: dose escalation and dose extension. The dose escalation stage sampled the "3+3" dose-escalation design, and set up three dose-increasing dose groups of 1.0×10\^5 CART cells/kg, 3.0×10\^5 CART cells/kg and 6.0×10\^5 CART cells/kg, and subjects will receive a single infusion of RD140. Each dose group level will include 3-6 subjects. In the dose expansion stage, 1\~2 dose groups were selected for expansion and 3\~6 subjects were included in each extended dose group, and the target dose was administered once.

Timeline

• Start date: 2024-10-25
• Primary completion: 2028-07-05
• Completion: 2041-07-05
• First posted: 2024-10-23
• Last updated: 2024-10-23