Actively Recruiting
A Study of CT0596 in Plasma Cell Leukemia
Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-08-01
27
Participants Needed
1
Research Sites
131 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
This study is a single-arm, open-label, exploratory dose-escalation and dosefinding clinical trial to evaluate the safety, efficacy, cellular pharmacokinetics and pharmacodynamics of CT0596 cells in patients with PCL.
CONDITIONS
Official Title
A Study of CT0596 in Plasma Cell Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign informed consent and commit to long-term follow-up for up to 15 years.
- Age 18 years or older.
- Diagnosed with plasma cell leukemia after induction treatment or relapsed/refractory primary plasma cell leukemia.
- Must have measurable disease.
- Expected survival longer than 12 weeks.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Good organ function.
- Women 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.
- Men must agree to use effective contraception for 1 year after treatment and are prohibited from sperm donation for 1 year.
You will not qualify if you...
- Pregnant or lactating women.
- Patients positive for HIV, or with active hepatitis B or C infections; treated hepatitis allowed if virus undetectable.
- Patients with uncontrolled active infections including active tuberculosis.
- Toxicities from previous treatments not recovered to Grade 1 or less, except alopecia and tolerable events.
- Significant medical conditions, lab abnormalities, or psychiatric illness that impair treatment tolerance or study participation.
- Previous allogeneic stem cell transplant or autologous transplant within 12 weeks before consent.
- Treatment for the disease within 14 days or five half-lives before preconditioning.
- Received cell therapy within 28 days before consent.
- Systemic glucocorticoids over 15 mg/day prednisone equivalent within 7 days before consent (topical exceptions).
- Vaccination with live attenuated, 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 (local anesthesia excepted).
- Allergies or intolerances to lymphodepletion, tocilizumab, DMSO, or history of serious allergies like anaphylaxis.
- Secondary plasma cell leukemia, Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis.
- Certain cardiac conditions within 6 months before screening.
- Need for supplemental oxygen or severe chronic obstructive pulmonary disease.
- Active autoimmune diseases requiring long-term immunosuppression.
- Second primary malignancies requiring recent treatment or not in remission, with some exceptions.
- Symptomatic central nervous system disease or suspected CNS metastases.
- Unable or unwilling to comply with protocol or unsuitable as judged by investigators.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here