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 Relapsed/Refractory Plasma Cell Leukemia
Led by Shanghai Changzheng Hospital · Updated on 2024-12-12
24
Participants Needed
1
Research Sites
51 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
Researchers are evaluating the safety, effectiveness, and behavior of CT0596 cells, a type of chimeric antigen receptor T cell therapy, in patients with relapsed or refractory multiple myeloma and plasma cell leukemia. This early-phase, open-label trial explores different dose levels to find the best balance between safety and treatment impact in these patients who have undergone previous therapies. Participants will receive an infusion of CT0596 cells, with doses adjusted according to safety and pharmacokinetic data using a stepwise method. The study includes a dose-limiting toxicity (DLT) assessment period of 28 days after infusion to evaluate immediate side effects. Dose escalation or reduction may occur, and some patients may be replaced if they cannot be evaluated for DLTs. Follow-up continues for safety and treatment effects beyond this period. During the trial, participants will undergo regular evaluations to monitor adverse events, treatment response, and the behavior of the infused cells in their bodies. These assessments include measuring response rates, survival, and cellular persistence up to 12 months post-infusion. Patients are expected to adhere to visit schedules and may be followed for up to 15 years to track long-term outcomes and safety.
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...
- Participants must voluntarily sign the informed consent form and agree to follow the study visit schedule and long-term follow-up up to 15 years
- Age 18 years or older
- Diagnosed with relapsed or refractory multiple myeloma having received at least 3 prior therapies including a proteasome inhibitor and an immunomodulator, or relapsed or refractory plasma cell leukemia having received at least 1 prior therapy
- Progressive disease following or during the last treatment
- Measurable disease based on defined parameters
- Expected survival greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Female participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception for 1 year after treatment; male participants must agree to use effective contraception for 1 year after treatment
You will not qualify if you...
- Pregnant or breastfeeding women
- Significant medical, laboratory, or psychiatric conditions that impair treatment tolerance or study participation
- Positive for HIV, active hepatitis B or C infection; treated hepatitis with undetectable viral load allowed
- Uncontrolled active infections including active tuberculosis
- Unresolved toxicities from previous treatments above grade 1 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
- Systemic glucocorticoids above 15 mg/day prednisone equivalent within 7 days before consent, except topical use
- Vaccination with live, inactivated, or RNA vaccines within 4 weeks before consent
- Allergies or intolerance to lymphodepletion, tocilizumab, DMSO, or history of severe allergies
- Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis
- Recent cardiac conditions within 6 months prior to screening
- Need for supplemental oxygen or severe COPD
- Active autoimmune diseases requiring long-term immunosuppressive therapy
- Recent or active second primary malignancies except certain treated non-metastatic skin or prostate cancers
- Symptomatic central nervous system disease or suspected CNS metastases
- Major surgery within 2 weeks before consent or planned during the 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days starting from the day of CT0596 infusion
Participants receive infusion of CT0596 CAR-T cells and undergo dose escalation or reduction based on safety and tolerability.
Multiple visits during the first 28 days for dose-limiting toxicity assessment
Duration - Up to 12 months after infusion
Participants are monitored for safety, efficacy, and pharmacokinetics up to 12 months after CT0596 infusion.
Regular visits for safety and efficacy assessments during 12 months
Trial Site Locations
Total: 1 location
1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Juan Du, 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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