Actively Recruiting
a Study of CT0596 in Relapsed/Refractory Multiple Myeloma and Relapsed/Refractory Plasma Cell Leukemia
Led by Shanghai Changzheng Hospital · Updated on 2024-12-12
24
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
S
Shanghai Changzheng Hospital
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-arm, open-label, exploratory dose-escalation and dose-finding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with R/R MM and PCL.RRMM and RRpPCL
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...
- Age 18 years or older
- Have relapsed or refractory multiple myeloma with at least 3 prior therapy lines including a proteasome inhibitor and immunomodulator, or relapsed/refractory plasma cell leukemia with at least 1 prior therapy
- Progressive disease after or during last treatment
- Measurable disease by defined parameters
- Expected survival longer than 12 weeks
- ECOG performance status of 0 or 1
- Female participants of childbearing potential must have a negative pregnancy test and use reliable contraception for 1 year after treatment
- Male participants must use reliable contraception for 1 year after treatment if sexually active with females of childbearing potential
- Willing and able to sign informed consent and comply with trial visits and long-term follow-up for up to 15 years
You will not qualify if you...
- Pregnant or lactating women
- Significant conditions or psychiatric illness that may interfere with treatment or assessments
- Active HIV, hepatitis B or C infections (unless treated and undetectable viral load)
- Uncontrolled active infections including tuberculosis
- Toxicities from previous treatments not resolved to grade 1 or less except alopecia
- Previous allogeneic stem cell transplant or recent autologous transplant within 12 weeks
- Treatment for disease within 14 days before consent
- Cell therapy within 28 days before consent
- Use of systemic glucocorticoids equivalent to >15 mg/day prednisone within 7 days before consent except topical use
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks before consent
- Allergies to lymphodepletion, tocilizumab, CT0596 components, or history of severe allergies
- Diagnosed with Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Recent cardiac conditions within 6 months
- Need for supplemental oxygen or severe COPD
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Recent or active second primary malignancies requiring treatment
- Symptomatic central nervous system disease or metastases
- Major surgery within 2 weeks before consent or planned during study or within 4 weeks after treatment except local anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Juan Du, 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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