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

NCT06655519 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-23

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Jin Lu · Peking University People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-25
Primary Completion
2028-07-05
Completion
2041-07-05

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06655519 on ClinicalTrials.gov