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Exploratory Clinical Trial of DQ1001 in Relapsed or Refractory Multiple Myeloma (RRMM)

NCT07622862 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-06-03

No results posted yet for this study

Summary

This is a prospective, single-arm, open-label, early exploratory clinical study designed to evaluate the safety, tolerability, and efficacy of the DQ1001 cell product in patients with relapsed or refractory multiple myeloma. All participants will receive intravenous infusions of DQ1001. The study consists of two phases: dose escalation and dose expansion. Following identification of an optimal dose during the dose-escalation phase, the cohort receiving that dose will be expanded to include a total of 12 participants-including those enrolled during dose escalation-to further assess the safety, tolerability, and efficacy of DQ1001.

Conditions

  • Multiple Myeloma Refractory
  • Multiple Myeloma Progression

Interventions

BIOLOGICAL

Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D

Patients received fludarabine and cyclophosphamide lymphodepleting preconditioning for three consecutive days-from day -5 (D-5) to day -3 (D-3)-prior to intravenous infusion of DQ1001.

Sponsors & Collaborators

  • Zhongshan Hospital (Xiamen), Fudan University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-09-30
Completion
2028-08-31

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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 NCT07622862 on ClinicalTrials.gov