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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
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.
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 DQ1001
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 years
Establish recommended Phase 2 dose (RP2D)
Time frame: Up to 2 years
efficacy endpoint: Overall response rate (ORR)
Time frame: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24
efficacy endpoint: Duration of Response (DoR)
Time frame: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24
efficacy endpoint: MRD negativity rate
Time frame: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24
efficacy endpoint: Time to response (TTR)
Time frame: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24
efficacy endpoint: progression-free survival (PFS)
Time frame: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24
Efficacy endpoint: Overall survival (OS)
Time frame: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24
Concentration of CAR-T cells after Infusion (PK)
Flow cytometry is used to determine the percentage and absolute count of CAR-T cells in peripheral blood, and polymerase chain reaction (PCR) is used to measure CAR copy numbers.
Time frame: Up to 2 years
Lymphocyte Subsets and Concentration of Cytokine after Infusion (PD)
Assessment of lymphocyte subsets (CD3+ T cells, CD4+ cells, CD8+ cells, etc.), CAR-T-related cytokines (IL-6, IL-8, IL-10, IL-2R, TNF-α, IFN-γ, IL-1β, ferritin, C-reactive protein, etc.), as well as CAR-T cell subset analysis and exhaustion markers.
Time frame: Up to 2 years
Anti-DQ1001 antibodies in peripheral blood
Time frame: Up to 2 years
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