Actively Recruiting
A Clinical Study to Explore the Safety, Efficacy, and Pharmacokinetics of CT0596 CAR-T Cell Injection in Patients With Plasma Cell Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-01
27
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
Sponsors
I
Institute of Hematology & Blood Diseases Hospital, China
Lead Sponsor
C
CARsgen Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are exploring the use of CT0596 cells, a type of CAR-T cell therapy, in patients with plasma cell leukemia (PCL). This early phase 1, single-arm, open-label trial aims to evaluate the safety, effectiveness, and behavior of these cells in the body. The study includes a dose-escalation and dose-finding process to determine the appropriate dose based on safety and pharmacokinetic data. Participants will receive infusions of CT0596 CAR-T cells. The trial may adjust doses up or down or expand the dose range during the study according to patient responses and tolerability. This approach follows the i3+3 principle to carefully monitor and manage dosing throughout the trial. During the study, participants will be closely monitored for adverse events and treatment effects for up to 12 months after infusion. Researchers will assess response rates, duration of response, progression-free survival, and overall survival, among other outcomes. Long-term follow-up for up to 15 years is also planned to observe safety and treatment persistence. Regular evaluations include blood tests, cytokine monitoring, and cellular measurements to understand the therapy's impact.
CONDITIONS
Brief Title
A Study of CT0596 in Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign the informed consent form and agree to long-term follow-up for up to 15 years.
- Age 18 years or older.
- Diagnosis of plasma cell leukemia after inductive treatment or relapsed/refractory primary plasma cell leukemia.
- Measurable disease present.
- Expected survival greater than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Good organ function.
- Female patients of childbearing potential must have a negative pregnancy test before lymphodepletion and agree to use effective contraception for 1 year after treatment; egg donation is prohibited for 1 year.
- Male patients who are sexually active with females of childbearing potential must use reliable contraception for 1 year after treatment; sperm donation is prohibited for 1 year.
You will not qualify if you...
- Pregnant or breastfeeding women.
- Patients with active HIV, hepatitis B or C infection (treated hepatitis allowed if viral load is undetectable).
- Uncontrolled active infections including active tuberculosis.
- Unresolved toxicities from previous treatments above Grade 1, except alopecia or tolerable events.
- Significant medical, laboratory, or psychiatric conditions that impair treatment tolerance or study participation.
- Previous allogeneic stem cell transplant or autologous stem cell transplant within 12 weeks before consent.
- Treatment for the disease within 14 days or five half-lives before preconditioning.
- Cell therapy received within 28 days before consent.
- Use of 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.
- Major surgery within 2 weeks before consent or planned during study or within 4 weeks after treatment (except local anesthesia).
- Allergies to lymphodepletion, tocilizumab, DMSO, or history of serious allergies like anaphylaxis.
- Diagnosis of secondary plasma cell leukemia, Waldenstr�f6m macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis.
- Cardiac conditions within 6 months prior to screening.
- Need for supplemental oxygen or severe COPD.
- Active autoimmune diseases requiring long-term immunosuppression.
- Recent or active second primary malignancies requiring treatment within 2 years, except certain treated skin or prostate cancers.
- Symptomatic or suspected central nervous system disease or metastases.
- Inability or unwillingness to comply with protocol or deemed unsuitable by investigators.
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 - Up to 12 months after infusion
Participants receive an infusion of CT0596 CAR-T cells and are monitored for safety, efficacy, and pharmacokinetics.
Multiple visits for assessments during and after infusion
Duration - Up to 15 years
Participants are followed for safety and long-term outcomes after treatment.
Periodic visits for long-term monitoring
Trial Site Locations
Total: 1 location
1
Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
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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