Exploratory Clinical Trial of DQ1001 in Relapsed or Refractory Multiple Myeloma (RRMM) (NCT07622862) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Exploratory Clinical Trial of DQ1001 in Relapsed or Refractory Multiple Myeloma (RRMM)
16 participantsStarted 2026-06
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Diagnosis of relapsed or refractory multiple myeloma (MM), per IMWG criteria:
. Tumor cells in bone marrow or peripheral blood are BCMA/GPRC5D-positive by flow cytometry; or tumor tissue is BCMA/GPRC5D-positive by immunohistochemistry.
. Presence of measurable disease at screening, defined as any one of the following:
. ECOG performance status score of 0-2.
. Expected survival ≥12 weeks.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Dose-limiting Toxicity (DLT)
Timeframe: Within 28 days after the infusion of DQ1001
2
Number of Participants with Adverse Events (AEs) by Severity
Timeframe: Up to 2 years
3
Establish recommended Phase 2 dose (RP2D)
Timeframe: Up to 2 years
Trial details
NCT IDNCT07622862
SponsorZhongshan Hospital (Xiamen), Fudan University
. Men with reproductive potential and women of childbearing potential must agree to use effective contraception from the time of ICF signing through two years after the last dose of study drug. Women of childbearing potential include premenopausal women and women within two years of menopause. A negative serum pregnancy test is required at screening for women of childbearing potential.
Exclusion criteria
. 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.
. Extensive radiotherapy administered within 28 days prior to signing the ICF; localized palliative radiotherapy to non-target lesions is permitted if administered within 14 days prior to signing the ICF or anticipated during the study period.
. Major surgical procedure performed within 28 days prior to signing the ICF, or planned major surgery during the study period.
. Positive hepatitis B surface antigen (HBsAg) at screening; or negative HBsAg but positive hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody and HCV RNA; positive human immunodeficiency virus (HIV) antibody; positive cytomegalovirus (CMV) DNA; or positive for both treponemal and non-treponemal antibodies for syphilis.
. Known hypersensitivity to any component of the study drugs, including but not limited to lymphodepleting agents (e.g., tocilizumab, cyclophosphamide, fludarabine) or contrast agents used for imaging studies.