Actively Recruiting
A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-10-01
24
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Soochow University
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and cellular metabolic behavior of CT0596 CAR-T cell injection in patients with relapsed or refractory multiple myeloma and plasma cell leukemia. This early phase 1 clinical trial aims to understand how this investigational treatment affects these conditions, which are forms of blood cancer that have returned or not responded to prior therapies. The study is sponsored by The First Affiliated Hospital of Soochow University and focuses on patients who have had multiple prior treatments. Participants receive an infusion of CT0596 chimeric antigen receptor T (CAR-T) cells, a type of immune cell therapy designed to target cancer cells. This treatment is administered during the study period, and participants are closely monitored for adverse effects and how their disease responds. The study includes long-term follow-up to assess safety and treatment impact over time, with careful tracking of the dose range and biological activity of the CAR-T cells. Throughout the trial, participants undergo regular assessments including monitoring for side effects, measuring disease response, and evaluating survival outcomes over 12 months after infusion. Researchers collect blood samples to study cytokine levels and CAR copy numbers, and track overall and progression-free survival rates. Participants agree to follow-up visits and evaluations for up to 15 years to support comprehensive safety and efficacy monitoring.
CONDITIONS
Brief Title
A Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/ Refractory Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign informed consent and agree to long-term follow-up for up to 15 years
- Age 18 years or older
- Patients with relapsed/refractory multiple myeloma who have had at least 3 prior therapy lines including a proteasome inhibitor and an immunomodulator; patients with relapsed/refractory plasma cell leukemia must have had at least 1 prior therapy line
- Patients must have progressive disease following or during their last treatment
- Patients must have measurable disease by defined parameters
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
- Female patients of childbearing potential must have a negative pregnancy test prior to lymphodepletion and agree to use reliable contraception for 1 year after treatment; male patients must agree to use reliable contraception for 1 year after treatment
You will not qualify if you...
- Pregnant or lactating women
- Significant conditions, lab abnormalities, or psychiatric illness that would impair treatment tolerance or study assessments
- Positive for HIV, active hepatitis B or C infection; treated hepatitis with undetectable viral load allowed
- Uncontrolled active infections including active tuberculosis
- Toxicities from prior treatment not resolved to grade 1 or lower except alopecia
- Previous allogeneic stem cell transplant; autologous transplant within 12 weeks prior to consent
- Treatment for disease within 14 days before consent
- Cell therapy within 28 days before consent
- Systemic glucocorticoids above 15 mg/day prednisone equivalent within 7 days before consent (except topical steroids)
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks before consent
- Allergic or intolerant to lymphodepletion, tocilizumab, DMSO, or history of serious allergies
- Secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Cardiac conditions within 6 months prior to screening
- Need for supplemental oxygen to maintain saturation above 92% or COPD with FEV1 below 50%
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Second primary malignancies requiring treatment within past 2 years or not in remission (exceptions apply)
- Symptomatic central nervous system disease or suspected CNS metastases
- Major surgery within 2 weeks before consent or planned during study or within 4 weeks after treatment (excluding local anesthesia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months after CT0596 infusion
Participants receive an infusion of CT0596 CAR-T cells as the investigational treatment for their condition.
Regular visits to monitor safety and treatment response during the 12 months after infusion
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
C
Chengcheng Fu, Ph D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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