Not Yet RecruitingPhase 1/2

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

China68 participantsStarted 2026-09-01

Plain-language 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.

Who can participate

Age range

18 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: * 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. * 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。 Exclusion Criteria: * 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, et…

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

Phase I:Adverse Events (AE) after CT0596 infusion

Timeframe: 24months after CT0596 infusion

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

Timeframe: 28 days after CT0596 infusion

Phase II:Overall response rate (ORR)

Timeframe: Week 12 after CT0596 infusion

Trial details

NCT IDNCT07760454

SponsorUCARsgen Biotech Limited

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-12-31

Contact for this trial

Juan Du

021-58752345 juan_du@live.com

View on ClinicalTrials.gov More Relapsed/Refractory Multiple Myeloma trials

Who can participate

Age range

18 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.