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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D
Biological/VaccinePatients 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.
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: DQ1001 Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose-limiting Toxicity (DLT)
DLT refers to drug-related toxicities that occur during treatment, the severity of which is clinically unacceptable, thereby restricting further dose escalation. All adverse events are assessed and graded by the investigator according to the NCI-CTCAE version 6.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded per the ASTCT criteria, and acute graft-versus-host disease (aGVHD) per the MAGIC criteria.
Time frame
Within 28 days after the infusion of DQ10012
Number of Participants with Adverse Events (AEs) by Severity
An adverse event is any untoward medical occurrence in a clinical study participant that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0. Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are graded per the ASTCT criteria, and acute graft-versus-host disease (aGVHD) per the MAGIC criteria.
Time frame
Up to 2 years3
Establish recommended Phase 2 dose (RP2D)
Time frame
Up to 2 yearsSecondary outcomes
1
efficacy endpoint: Overall response rate (ORR)
Time frame
Assessment at months 1, 2, 3, 6, 9, 12, 18, and 242
efficacy endpoint: Duration of Response (DoR)
Time frame
Assessment at months 1, 2, 3, 6, 9, 12, 18, and 243
efficacy endpoint: MRD negativity rate
Time frame
Assessment at months 1, 2, 3, 6, 9, 12, 18, and 244
efficacy endpoint: Time to response (TTR)
Time frame
Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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