ClinicalTrials.gg
RecruitingNCT07760454Updated Sep 17, 2026

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

A Phase 1/2 interventional study of CT0596 in Relapsed/Refractory Multiple Myeloma, sponsored by UCARsgen Biotech Limited. Recruiting at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by UCARsgen Biotech Limited · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 447 studies in Multiple Myeloma with a site in China — 237 open to participants now, 274 under way, 47 of them phase 3. Multiple Myeloma · China.

Planned enrollment
149th of 405
68 · median 40
Started
2026
with 52 others
Phase 1/2
65 of 447
43 open now
Primary completion
2030-12
later than 261 of 273 live
Registered
436th of 447
by date

Among the 447 studies in Multiple Myeloma with a site in China, this one is the 149th largest by planned enrollment of the 405 interventional ones that give a count, is one of 53 that started in 2026, is one of 65 in phase 1/2, reaches primary completion later than 261 of the 273 other live ones, and was the 436th registered.

Multiple Myeloma

3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

237 of the 447 studies in Multiple Myeloma with a site in China are open now. Recruiting first, the newest first:

231 more — sign in →

All 237 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 584 Multiple Myeloma studies recruiting now, 429 (73%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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02

Study 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 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.

03

Conditions studied

  • Relapsed/Refractory Multiple Myeloma

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Voluntarily participate in the trial; fully understand and sign the form (ICF); willing and able to comply with all trial procedures.
  • Age ≥ 18 years, male or female.
  • Patients with multiple myeloma (R/R MM) who have received at least 3 , 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 :
  • ≥ 12 weeks.
  • (ECOG) performance status of 0-1.
  • Must have Adequate organ function
  • Female participants of must have a negative pregnancy test at screening and prior to lymphodepletion, and must agree to use highly effective 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。

Exclusion criteria

Exclusion Criteria:

  • Pregnant or lactating women.
  • Positive for , syphilis, active (HBV-DNA above LLoD), or active (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 (CTCAE) V5.0 (except alopecia and other events deemed tolerable by the investigator).
  • Prior BCMA-targeted therapy (refer to the protocol for exceptions).
  • Prior stem cell transplantation; or autologous SCT within 3 months prior to signing ICF; or planned Hematopoietic Stem Cell Transplantation(HSCT) during the trial.
  • 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 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 requiring treatment or not in complete remission within 2 years prior to screening, except for successfully treated non- 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 .
  • Patients assessed by the investigator as unable or unwilling to comply with protocol requirements, or otherwise unsuitable for participation.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    CAR-T cells

    chimeric antigen receptor T cells

    Drug: CT0596

Interventions

  • DrugCT0596

    CAR-T cells

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Week 12 after CT0596 infusion

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 24 months after CT0596 infusion

  10. Cytokines in the peripheral blood

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

    Time frame: up to 24 months after CT0596 infusion

  11. Immunogenicity (anti-drug antibodies)

    Serum concentrations of anti-drug antibodies after CT0596 infusion

    Time frame: up to 24 months after CT0596 infusion

07

Study locations

1 of 2 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2030, 51 months after the start.

Of 103 non-industry phase 1/2 interventional studies under Multiple Myeloma, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 46 and three quarters within 94. This study's planned 51 months is below that.

Counting every sponsor, half of 201 studies reached it within 65 months; a quarter within 44 and three quarters within 92.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 2, 2026
First posted
Aug 12, 2026
StartActual
Sep 3, 2026
Primary completionEst.
Dec 31, 2030
CompletionEst.
Apr 30, 2031
Last update
Sep 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07760454
Lead sponsor
UCARsgen Biotech Limited
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Sep 3, 2026
Primary completion
Dec 31, 2030 (estimated)
Completion
Apr 30, 2031 (estimated)
Last update
Sep 17, 2026

Study contacts

Juan Du
Contact
juan_du@live.com
021-58752345
Chengcheng Fu
Contact
fuzhengzheng@suda.edu.cn
0512-65223637

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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