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.
Age 18 to 75 years old, male or female;
Diagnosed as Multiple Myeloma (MM) according to the international standard for multiple myeloma (IMWG), or diagnosed as primary plasma cell leukemia;
Subjects have had at least 3 prior lines of therapy including at least one proteasome inhibitor (PI), one immunomodulatory agent (IMiD), and one anti-CD38 monoclonal antibody, or subjects who were refractory to the above treatments.
Disease progression must be documented during or within 12 months following the most recent anti-tumor treatment (the progression for subjects whose last line treatment was CAR-T therapy was not limited to 12 months post-treatment);
Subjects who are known to have Graft-Versus-host disease (GVHD) or need long-term immunosuppressive therapy;
Subjects have received an autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks before leukapheresis or have a previous history of two times of auto-HSCT or previous history of an allogeneic hematopoietic stem cell transplantation (allo-HSCT);
Received targeted plasma cell therapy within 3 months before leukapheresis, or previous cell therapy products can still be detected in peripheral blood.
Monoclonal antibody for multiple myeloma or plasma cell leukemia within 21 days, or;
Single group
CAR-T（RD140 injection）
Biological/VaccineThis 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.
Adverse Events
Type and incidence of adverse events (AEs)
Overall response rate (ORR)
Proportion of subjects who achieved sCR, CR, VGPR, and PR after receiving study therapy
Duration of Response (DOR)
Time from first response to disease progression or death from any cause
Progression-free Survival (PFS)
Time from RD140 infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first
Overall Survival (OS)
Time from RD140 infusion to time of death due to any cause
Immunogenicity
Presence of human anti-CAR antibodies, and titer of confirmed positive antibody in peripheral blood
replication competent lentivirus (RCL)
The incidence of replication competent lentivirus
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