NCT07760454

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
57mo left

Started Sep 2026

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2031

Last Updated

August 12, 2026

Status Verified

July 1, 2026

Enrollment Period

4.3 years

First QC Date

August 2, 2026

Last Update Submit

August 9, 2026

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

  • 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.

    24months after CT0596 infusion

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

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

    28 days after CT0596 infusion

  • 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.

    Week 12 after CT0596 infusion

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (1)

CAR-T cells

EXPERIMENTAL

chimeric antigen receptor T cells

Drug: CT0596

Interventions

CT0596DRUG

CAR-T cells

CAR-T cells

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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。

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Renji Hospital,Shanghai Jiao Tong University School Of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

Juan Du

CONTACT

021-58752345juan_du@live.com

Chengcheng Fu

CONTACT

0512-65223637fuzhengzheng@suda.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2026

First Posted

August 12, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

April 30, 2031

Last Updated

August 12, 2026

Record last verified: 2026-07

Locations

CN(2)