Actively Recruiting
A Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/ Refractory Plasma Cell Leukemia
Led by The First Affiliated Hospital of Soochow University · Updated on 2025-10-01
24
Participants Needed
1
Research Sites
127 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
A Clinical Study to Explore the Safety, Efficacy, and Cellular Metabolic Dynamics of CT0596 CAR-T Cell Injection in Patients With Relapsed/Refractory Multiple Myeloma and Plasma Cell Leukemia.
CONDITIONS
Official 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 the informed consent form and agree to adhere to the trial schedule including long-term follow-up for up to 15 years
- Age 18 years or older
- Patients with relapsed/refractory multiple myeloma who have received at least 3 prior lines of therapy including at least 1 proteasome inhibitor and 1 immunomodulator; patients with relapsed/refractory plasma cell leukemia must have received at least 1 prior line of therapy
- Patients must have progressive disease following or during their last treatment
- Patients must have measurable disease based on at least one parameter
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Female patients of childbearing potential must have a negative pregnancy test before treatment and agree to use effective contraception for 1 year after treatment; male patients must agree to use effective contraception for 1 year after treatment if sexually active with females of childbearing potential
You will not qualify if you...
- Pregnant or breastfeeding women
- Significant conditions, laboratory abnormalities, or psychiatric illnesses that would interfere with treatment or study participation
- Positive for HIV, active hepatitis B or C infection (treated hepatitis B or C allowed if viral load is undetectable)
- Any uncontrolled active infection including active tuberculosis
- Toxicities from prior treatments not recovered to grade 1 or less (except alopecia and tolerable events)
- Previous allogeneic stem cell transplantation or autologous stem cell transplantation within 12 weeks prior to consent
- Treatment for the disease within 14 days before consent
- Received cell therapy within 28 days before consent
- Use of systemic glucocorticoids equivalent to more than 15 mg/day prednisone within 7 days prior to consent (except topical use)
- Vaccination with live attenuated, inactivated, or RNA vaccines within 4 weeks prior to consent
- Allergies or intolerance to lymphodepletion, tocilizumab, DMSO, or history of serious allergic reactions
- Secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis at screening
- Certain cardiac conditions within 6 months prior to screening
- Need for supplemental oxygen to maintain saturation above 92% or COPD with FEV1 less than 50%
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Second primary malignancies requiring treatment within past 2 years or not in remission (some 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
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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
CONTACT
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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