Actively Recruiting
A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy
Led by Affiliated Hospital of Nantong University · Updated on 2025-01-03
9
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
A
Affiliated Hospital of Nantong University
Lead Sponsor
S
Shanghai First Song Biotechnology Co., LTD
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.
CONDITIONS
Official Title
A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and less than 70 years
- Willing and able to voluntarily participate and complete all study procedures with signed informed consent
- Relapsed or refractory disease after standard treatments, including stem cell transplantation, not suitable for other options
- Specific disease criteria for relapsed/refractory B-cell acute lymphoblastic leukemia, Ph+ B-cell ALL, non-Hodgkin lymphoma, and Hodgkin lymphoma as defined in the protocol
- Indications for enrollment in anti-CD19, anti-CD20/30, or anti-CD30 CAR T-cell cohorts based on disease subtype and marker expression
- ECOG performance status of 2 or less
- Expected survival of at least 12 weeks
- Adequate venous access for apheresis without contraindications
- Laboratory values meeting specified thresholds for blood counts, liver and kidney function
- Ejection fraction 45% or higher with no significant heart or oxygenation issues
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- CNS abnormalities with clinically significant neurological changes or active CNS lymphoma not adequately treated
- Active central nervous system diseases such as epilepsy, cerebrovascular events, dementia, or autoimmune diseases involving CNS
- History or current presence of other malignancies
- Significant uncontrolled cardiac disease or arrhythmias
- Uncontrolled infections requiring IV antibiotics (except uncomplicated UTIs or pharyngitis)
- Positive for hepatitis B or C, syphilis, or HIV infection
- Presence of indwelling or drainage catheters, except specialized central venous access devices
- Recent use of specific medications including clofarabine, cladribine, live vaccines, donor lymphocyte infusion, immunosuppressive or immunostimulatory drugs, recent chemotherapy, growth factors, radiation, corticosteroids above physiological doses, or targeted therapies within defined windows
- Active graft-versus-host disease grade 2 or higher requiring systemic steroids beyond physiological doses
- History of autoimmune diseases causing organ injury or requiring systemic immunosuppression within 2 years
- Recent significant cardiac events within 12 months
- Genetic syndromes associated with bone marrow failure
- Recent symptomatic deep vein thrombosis or pulmonary embolism requiring anticoagulation
- Use of other investigational products within 30 days
- Pregnant or breastfeeding women and those unwilling to use birth control during and 12 months after treatment
- Any medical condition or activities interfering with safety or efficacy assessments
- Unlikely to complete protocol procedures or comply with study requirements according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
Actively Recruiting
Research Team
H
Hong Liu, MD
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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