Actively Recruiting
Anti-CD19-CAR-T Cells in Subjects With Relapsed/Refractory B Cell Malignancies
Led by Shanghai First Song Biotechnology Co., LTD · Updated on 2025-02-28
9
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
Sponsors
S
Shanghai First Song Biotechnology Co., LTD
Lead Sponsor
T
The First Affiliated Hospital of Anhui Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-center, single-arm, open-label, exploratory study to determine the safety, tolerability, feasibility, and preliminary anti-tumor activity of anti-CD19-CAR-T cells in subjects with relapsed/refractory (r/r) B-cell malignancies. This study plans to enroll patients with relapsed/refractory CD19-positive B-cell malignancies, who will receive a single infusion of anti-CD19-CAR-T cells after screening, PBMC collection, and lymphodepleting chemotherapy.
CONDITIONS
Official Title
Anti-CD19-CAR-T Cells in Subjects With Relapsed/Refractory B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent or have a parent/guardian provide consent for minors
- Age between 14 and 70 years
- Relapsed or refractory CD19-positive B-cell malignancy after standard treatment and ineligible for other options like second stem cell transplant
- Specific definitions of relapsed/refractory B-cell acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma (NHL) as detailed in protocol
- Bone marrow with 5% or more lymphoblasts at screening
- Eligible subtypes of relapsed/refractory NHL including DLBCL-NOS, PMBCL, transformed follicular lymphoma, mantle cell lymphoma, high-grade B-cell lymphoma, and CLL/SLL
- ECOG performance status 2 or less
- Life expectancy of at least 12 weeks
- Adequate venous access for apheresis and no contraindications to blood cell separation
- Specific laboratory criteria for neutrophils, hemoglobin, platelets, lymphocytes, liver function, and kidney function at screening
- Cardiac ejection fraction of 45% or higher with no significant ECG abnormalities
- Baseline oxygen saturation above 92% on room air
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Central nervous system involvement with significant neurological changes (CNS-2 with symptoms or CNS-3)
- CNS lymphoma not effectively treated or active CNS diseases such as epilepsy or dementia
- Any malignancies other than CD19-positive malignancies
- Significant heart disease or uncontrolled arrhythmias
- Uncontrolled infections requiring intravenous antibiotics
- Presence of hepatitis B, hepatitis C, syphilis, or HIV infection
- Use of indwelling or drainage catheters except certain central venous devices
- Prior use of CD19-targeted therapies or specific drugs and therapies as detailed in protocol within defined timeframes
- Grade 2 or higher graft-versus-host disease requiring systemic corticosteroids
- Recent autoimmune diseases requiring immunosuppression
- Recent serious cardiac events within 12 months
- Genetic syndromes causing bone marrow failure
- Recent deep vein thrombosis or pulmonary embolism requiring anticoagulation
- History or current other malignant tumors except certain controlled or non-invasive types
- Use of other investigational drugs within 30 days
- Pregnant or breastfeeding women, or those planning pregnancy
- Unwillingness to use contraception during and after treatment
- Any medical history that may interfere with safety or evaluation
- Likely inability to complete study visits or procedures
- Previous use of any CAR-T or gene-modified T cell therapies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230022
Actively Recruiting
Research Team
L
Long
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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