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Relapsed/Refractory Multiple MyelomaPhase 1/2NCT07760454

A Clinical Study of CT0596 CAR-T in Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing CT0596 in people with Relapsed/Refractory Multiple Myeloma, run by UCARsgen Biotech Limited at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a Phase I/II, single-arm, open-label, multicenter clinical trial in patients with relapsed/refractory multiple myeloma (R/R MM). The study aims to evaluate the safety, tolerability, efficacy, cellular kinetics, and immunogenicity of CT0596. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
CT0596
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
2 sitesChina
Study dates
3 Sep 2026to 30 Apr 2031
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily participate in the trial; fully understand and sign the informed consent form (ICF); willing and able to comply with all trial procedures.
  • Age ≥ 18 years, male or female.
  • Patients with relapsed/refractory multiple myeloma (R/R MM) who have received at least 3 prior lines of therapy, including at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and at least one anti-CD38 monoclonal antibody.
  • Relapsed/refractory disease defined per IMWG 2016 response criteria,.
  • Must have measurable disease:
  • Life expectancy ≥ 12 weeks.
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  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Must have Adequate organ function
  • Female participants of childbearing potential must have a negative pregnancy test at screening and prior to lymphodepletion, and must agree to use highly effective contraception for at least 1 year after CT0596 infusion, and absolutely refrain from oocyte donation. Male participants with active sexual life with WOCBP must agree to use highly effective contraception for at least 1 year after infusion and absolutely refrain from sperm donation。

Who cannot join

  • Pregnant or lactating women.
  • Positive for HIV, syphilis, active hepatitis B (HBV-DNA above LLoD), or active hepatitis C (positive for both HCV antibody and HCV-RNA).
  • Presence of any uncontrolled active infection, including but not limited to active tuberculosis (per investigator), active CMV and/or EBV infection, etc.
  • Toxicity from prior therapy not recovered to ≤ Grade 1 per Common Terminology Criteria for Adverse Events(CTCAE) V5.0 (except alopecia and other events deemed tolerable by the investigator).
  • Prior BCMA-targeted therapy (refer to the protocol for exceptions).
  • Prior allogeneic stem cell transplantation; or autologous SCT within 3 months prior to signing ICF; or planned Hematopoietic Stem Cell Transplantation(HSCT) during the trial.
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  • Received disease-directed therapy within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.
  • Received any cell therapy within 6 months prior to ICF; or prior CAR-T with best response < PR.
  • Received systemic corticosteroids equivalent to > 15 mg/day of prednisone within 7 days prior to lymphodepletion (excluding topical use).
  • Received live-attenuated, inactivated, or RNA vaccines within 4 weeks prior to lymphodepletion.
  • Major surgery within 2 weeks prior to lymphodepletion, or planned major surgery during trial or within 4 weeks after treatment (excluding local anesthesia surgeries).
  • Allergy or intolerance to lymphodepletion agents, tocilizumab, or any component of infusion (e.g., DMSO); or history of severe allergy such as anaphylactic shock.
  • Diagnosed with secondary plasma cell leukemia, solitary extramedullary plasmacytoma, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at screening.
  • Severe cardiac diseases within 6 months prior to screening.
  • Severe pulmonary disease that may jeopardize the patient's life per investigator.
  • Inability to tolerate an adequate lymphodepletion regimen.
  • Secondary primary malignancy requiring treatment or not in complete remission within 2 years prior to screening, except for successfully treated non-metastatic basal/squamous cell skin carcinoma, non-metastatic prostate cancer, carcinoma in situ (breast/cervix), non-muscle-invasive bladder cancer, or low-grade thyroid cancer.
  • Known symptomatic central nervous system (CNS) disease or suspected CNS metastasis.
  • Patients assessed by the investigator as unable or unwilling to comply with protocol requirements, or otherwise unsuitable for participation.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Juan Du contact

021-58752345

juan_du@live.com

Chengcheng Fu contact

0512-65223637

fuzhengzheng@suda.edu.cn

China2 sites, 2 recruiting

  • Renji Hospital,Shanghai Jiao Tong University School Of Medicine

    Shanghai

    Juan Du, 021-58752345, juan_du@live.com

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

    Chengcheng Fu, 0512-65223637, fuzhengzheng@suda.edu.cn

    Not yet recruiting

Other trials in China

About this study

Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Efficacy, and Cellular Kinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma

This is a Phase I/II, single-arm, open-label, multicenter clinical trial in patients with relapsed/refractory multiple myeloma (R/R MM). The study aims to evaluate the safety, tolerability, efficacy, cellular kinetics, and immunogenicity of CT0596.

Read the detailed description

Phase I employs a BOIN design for dose escalation to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D). Phase II will further confirm the clinical efficacy of CT0596 at the RP2D in R/R MM, with the primary efficacy endpoint being the overall response rate (ORR) at Week 12 post-infusion, assessed by an Independent Review Committee (IRC) per International Myeloma Working Group(IMWG) 2016 criteria.

Being tested
CT0596
Medical subject headings
Multiple Myeloma

What participants receive

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

  • CT0596Drug

    CAR-T cells

Study groups in NCT07760454
Study groupRoleWhat they receive
CAR-T cellsExperimentalchimeric antigen receptor T cells
Receives: Drug: CT0596

What is being measured

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

  1. Phase I:Adverse Events (AE) after CT0596 infusion

    An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria.

    Measured: 24months after CT0596 infusion

  2. Phase I:Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)

    Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion.

    Measured: 28 days after CT0596 infusion

  3. Phase II:Overall response rate (ORR)

    Overall response rate (ORR) at Week 12 post-infusion, assessed by an Independent Review Committee (IRC) per IMWG 2016 criteria.

    Measured: Week 12 after CT0596 infusion

Secondary outcomes (11)

  1. Overall response rate (ORR) as assessed by IRC and investigator

    Overall response rate (ORR) defined as proportion of patients achieving partial response or better based on International Myeloma Working Group defined response criteria by IRC and investigator.

    Measured: 24 months after CT0596 infusion

  2. Complete response/stringent complete response (CR/sCR) rate

    Rate of complete response/stringent complete response (CR/sCR) defined as proportion of patients achieving CR or better based on IMWG defined response criteria.

    Measured: 24 months after CT0596 infusion

  3. Rate of very good partial response (VGPR) and above

    the proportion of patients achieving very good partial response, complete response or stringent complete response per IMWG response criteria.

    Measured: 24 months after CT0596 infusion

  4. Duration of response (DOR)

    DOR is defined as the time from first achieving Partial Response (PR) or better to confirmed disease progression or death from any cause.

    Measured: 24 months after CT0596 infusion

  5. Minimal residual disease (MRD) negative rate

    MRD negative rate is defined as the proportion of patients achieve a MRD negative by NGF(Next Generation Flow) at a sensitivity of 10-5.

    Measured: 24 months after CT0596 infusion

  6. Time to response (TTR)

    TTR defined as the time from the date of infusion to the date of initial assessment of PR or better according to IMWG2016 criteria.

    Measured: 24 months after CT0596 infusion

  7. Progression-free survival (PFS)

    PFS defined as the time from the date of infusion of the subject to the first assessment of confirmed disease progression or death from any cause according to IMWG2016 criteria, whichever occurs first.

    Measured: 24 months after CT0596 infusion

  8. Overall survival (OS)

    OS defined as the time from the date of infusion of the subject to death from any cause.

    Measured: after CT0596 infusion

  9. Pharmacokinetic parameters of CT0596, including CAR copy number, peak value, AUC (area under the curve), in vivo persistence, etc

    Time to peak expansion, peak expansion, area under the curve (AUC) and duration in plasma after infusion of CT0596 cells.

    Measured: 24 months after CT0596 infusion

  10. Cytokines in the peripheral blood

    Serum concentrations of interleukin (IL)-6 after CT0596 infusion.

    Measured: up to 24 months after CT0596 infusion

  11. Immunogenicity (anti-drug antibodies)

    Serum concentrations of anti-drug antibodies after CT0596 infusion

    Measured: up to 24 months after CT0596 infusion

Timeline

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

  1. First posted12 Aug 2026
  2. Study start3 Sep 2026
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion30 Apr 2031 (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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07760454
Sponsor's protocol ID
CT0596-MM-03
Status last verified
Sep 2026
First submitted
2 Aug 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CT0596 in people with Relapsed/Refractory Multiple Myeloma, run by UCARsgen Biotech Limited at 2 sites in China.

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 9 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Juan Du (021-58752345, juan_du@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I:Adverse Events (AE) after CT0596 infusion (time frame: 24months after CT0596 infusion). 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 NCT07760454.

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 17 Sep 2026.

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