Exploratory Clinical Trial of DQ1001 in Relapsed or Refractory Multiple Myeloma (RRMM)
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhongshan Hospital (Xiamen), Fudan University
About this trial
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.
Eligibility criteria
Qualifiers
Voluntary signing of the Informed Consent Form (ICF) prior to undergoing any study-related procedures.
Age at the time of ICF signing is between 18 and 70 years inclusive.
Prior receipt of at least three lines of therapy;
Documented progressive disease (PD) during the most recent therapy or within two months after its completion, or documented failure to achieve at least minimal response (MR) within two months after the most recent therapy.
Disqualifiers
Central nervous system (CNS) metastases, leptomeningeal disease, or metastatic CNS compression; or a prior history of CNS disorders, including but not limited to epilepsy, hemiplegia, aphasia, stroke, severe traumatic brain injury, dementia, or Parkinson's disease.
Prior treatment with CAR-T therapy or drugs targeting BCMA or GPRC5D.
Active or moderate-to-severe chronic graft-versus-host disease (GVHD) within four weeks prior to signing the informed consent form (ICF), or systemic GVHD-directed therapy within four weeks before the first infusion.
Any investigational drug or systemic antitumor therapy administered within 28 days (or five half-lives of the drug, whichever is deemed more appropriate by the investigator) prior to the first infusion.
Trial design
Treatments tested in this trial
- Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D
Treatment groups
16 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov