NCT07760454RecruitingPhase 1
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
UCARsgen Biotech Limited4 sites in 1 country68 target enrollmentStarted: September 3, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 68
- Locations
- 4
- Primary Endpoint
- Phase I:Adverse Events (AE) after CT0596 infusion
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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-
- •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, 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.
- •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.
Arms & Interventions
CAR-T cells
Experimental
chimeric antigen receptor T cells
Intervention: CT0596 (Drug)
Outcomes
Primary Outcomes
Phase I:Adverse Events (AE) after CT0596 infusion
Time Frame: 24months after CT0596 infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria.
Phase I:Maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D)
Time Frame: 28 days after CT0596 infusion
Evaluate Dose limited toxicity and recommended dosage range after CT0596 infusion.
Phase II:Overall response rate (ORR)
Time Frame: Week 12 after CT0596 infusion
Overall response rate (ORR) at Week 12 post-infusion, assessed by an Independent Review Committee (IRC) per IMWG 2016 criteria.
Secondary Outcomes
- Overall survival (OS)(after CT0596 infusion)
- Overall response rate (ORR) as assessed by IRC and investigator(24 months after CT0596 infusion)
- Complete response/stringent complete response (CR/sCR) rate(24 months after CT0596 infusion)
- Rate of very good partial response (VGPR) and above(24 months after CT0596 infusion)
- Duration of response (DOR)(24 months after CT0596 infusion)
- Minimal residual disease (MRD) negative rate(24 months after CT0596 infusion)
- Time to response (TTR)(24 months after CT0596 infusion)
- Progression-free survival (PFS)(24 months after CT0596 infusion)
- Pharmacokinetic parameters of CT0596, including CAR copy number, peak value, AUC (area under the curve), in vivo persistence, etc(24 months after CT0596 infusion)
- Cytokines in the peripheral blood(up to 24 months after CT0596 infusion)
- Immunogenicity (anti-drug antibodies)(up to 24 months after CT0596 infusion)
Investigators
Study Sites (4)
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