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Multiple Myeloma RefractoryPhase 1NCT07622862

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

A Phase 1 study testing Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D in people with Multiple Myeloma Refractory and Multiple Myeloma Progression, run by Zhongshan Hospital (Xiamen), Fudan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
No sites listed yet
Study dates
Jun 2026to Aug 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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.
  • Tumor cells in bone marrow or peripheral blood are BCMA/GPRC5D-positive by flow cytometry; or tumor tissue is BCMA/GPRC5D-positive by immunohistochemistry.
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  • Presence of measurable disease at screening, defined as any one of the following:
  • For IgG-type MM: serum monoclonal M-protein ≥10 g/L; for IgA-, IgD-, IgE-, or IgM-type MM: serum monoclonal M-protein ≥5 g/L; or
  • Urinary M-protein ≥200 mg/24 h; or
  • Light-chain MM: involved serum free light chain (FLC) ≥100 mg/L and abnormal serum FLC κ/λ ratio (<0.26 or >1.65).
  • ECOG performance status score of 0-2.
  • Expected survival ≥12 weeks.
  • 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.
  • For patients who previously underwent hematopoietic stem cell transplantation: no active graft-versus-host disease (GVHD), and systemic immunosuppressants discontinued for at least four weeks.
  • Adequate major organ function, defined as follows:
  • Hematologic: absolute neutrophil count (ANC) ≥1.0 × 10⁹/L; hemoglobin ≥70 g/L; platelet count ≥50 × 10⁹/L; lymphocyte count >0.2 × 10⁹/L;
  • Coagulation: fibrinogen ≥1.0 g/L; activated partial thromboplastin time (APTT) ≤1.5 × upper limit of normal (ULN); prothrombin time (PT) ≤1.5 × ULN;
  • Hepatic: total bilirubin ≤2 × ULN (≤3 × ULN in patients with Gilbert syndrome); aspartate aminotransferase (AST) ≤3 × ULN; alanine aminotransferase (ALT) ≤3 × ULN;
  • Cardiopulmonary: left ventricular ejection fraction ≥50%; peripheral capillary oxygen saturation ≥92% without supplemental oxygen, or ≥95% with supplemental oxygen;
  • Renal: estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m² (calculated using the CKD-EPI equation).
  • Investigator judgment that the participant is able to comply with protocol requirements and complete treatment and follow-up.

Who cannot join

  • 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.
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  • 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.
  • Severe respiratory disease (including but not limited to severe or very severe chronic obstructive pulmonary disease, interstitial lung disease); or significant cardiovascular history (including but not limited to coronary artery bypass grafting or percutaneous coronary intervention within six months prior to signing the ICF, myocardial infarction, New York Heart Association [NYHA] Class III-IV congestive heart failure, unstable angina, corrected QT interval (QTcF) > 480 ms, personal or familial history of long or short QT syndrome, uncontrolled severe arrhythmia or hypertension requiring pharmacologic management).
  • Any comorbidity or other condition judged by the investigator to potentially compromise adherence to the study protocol or render the participant unsuitable for participation in this study.
  • Pregnant or lactating women, or women planning pregnancy or unwilling to use highly effective, reliable contraception during the study and for two years following completion of study treatment.
  • Uncontrolled active infection (excluding those viral infections listed above), including but not limited to serious bacterial, fungal, or other viral infections deemed by the investigator to increase the risk associated with study treatment.
  • Receipt of a live attenuated viral vaccine within one month prior to signing the ICF.
  • History of immunodeficiency disorder or active autoimmune disease (patients with stable autoimmune disease at enrollment who have not required systemic immunosuppressive therapy for ≥6 months are exempted).
  • Diagnosis of any malignancy other than multiple myeloma within the past two years prior to screening, except for: malignancies treated with curative intent and without evidence of active disease for ≥2 years prior to enrollment; adequately treated non-melanoma skin cancer with no current evidence of disease; or carcinoma in situ treated with curative intent.

About this study

Official title: An Early Exploratory Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Efficacy of DQ1001-a Universal Allogeneic CAR-T Cell Infusion Targeting Both BCMA and GPRC5D-in Patients With Relapsed or Refractory Multiple Myeloma (RRMM).

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.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5DBiological

    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.

Study groups in NCT07622862
Study groupRoleWhat they receive
DQ1001 Treatment GroupExperimentalNot described
Receives: Biological: Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Within 28 days after the infusion of DQ1001

  2. 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.

    Measured: Up to 2 years

  3. Establish recommended Phase 2 dose (RP2D)

    Measured: Up to 2 years

Secondary outcomes (9)

  1. efficacy endpoint: Overall response rate (ORR)

    Measured: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24

  2. efficacy endpoint: Duration of Response (DoR)

    Measured: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24

  3. efficacy endpoint: MRD negativity rate

    Measured: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24

  4. efficacy endpoint: Time to response (TTR)

    Measured: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24

  5. efficacy endpoint: progression-free survival (PFS)

    Measured: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24

  6. Efficacy endpoint: Overall survival (OS)

    Measured: Assessment at months 1, 2, 3, 6, 9, 12, 18, and 24

  7. 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.

    Measured: Up to 2 years

  8. 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.

    Measured: Up to 2 years

  9. Anti-DQ1001 antibodies in peripheral blood

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionSep 2027 (estimated)
  4. Study completionAug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07622862
Sponsor's protocol ID
DQ1001-IIT-001
Status last verified
May 2026
First submitted
23 May 2026
Last updated
3 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Allogeneic, off-the-shelf CAR-T cell injection targeting BCMA and GPRC5D in people with Multiple Myeloma Refractory and Multiple Myeloma Progression, run by Zhongshan Hospital (Xiamen), Fudan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Dose-limiting Toxicity (DLT) (time frame: Within 28 days after the infusion of DQ1001). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07622862.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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