Actively Recruiting
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults
Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2026-03-13
18
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a single arm, open label, dose exploring clinical trial to evaluate the safety, efficacy, cellular metabolic dynamics, and pharmacodynamics of ct1190b cells in relapsed / refractory B-cell acute lymphoblastic leukemia.
CONDITIONS
Official Title
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Kinetics of Universal Car-t Cell Injection in CD19 and / or CD20 Positive Relapsed / Refractory B-cell Acute Lymphoblastic Leukemia in Adolescents, Children and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Aged between 12 and 75 years inclusive
- Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia by morphology, immunology, or molecular science
- Meet specified remission or relapse conditions including failure to achieve remission after induction chemotherapy or relapse timing criteria
- For Philadelphia chromosome-positive patients, received at least two tyrosine kinase inhibitors without remission or relapse (with specified exceptions)
- Positive for CD19 and/or CD20 in bone marrow or peripheral blood
- Bone marrow or peripheral blood blast cells proportion of 5% or more
- Estimated survival longer than 12 weeks
- Meet specified laboratory test results including creatinine clearance, liver enzymes, bilirubin, coagulation tests, oxygen saturation, and heart ejection fraction
- Male participants who have active sex with women of reproductive potential agree to use effective contraception for 1 year post-treatment and agree not to donate sperm within 1 year after treatment
You will not qualify if you...
- Pregnant or lactating women
- Infection with HIV, syphilis, active hepatitis B or C virus
- Uncontrolled active infection including active tuberculosis
- Active systemic autoimmune disease
- Presence of solitary extramedullary lesions
- History of neurological diseases including epilepsy, intracranial hemorrhage, brain injury, cerebellar disease, memory impairment, spinal cord compression, or suspected active CNS metastasis
- Genetic bone marrow failure syndromes (e.g., Fanconi anemia, Kostmann syndrome, Shwachman syndrome), except Down syndrome
- Previous relapse after CD19/CD20 targeted treatment deemed unlikely to benefit
- Stem cell transplantation within 12 weeks prior to consent
- Donor lymphocyte infusion within 6 weeks prior
- Recent treatments before cell infusion including chemotherapy within 7 days, hydroxyurea or tyrosine kinase inhibitors within 3 days, radiotherapy within 1 week (longer for lung and CNS), CNS prophylactic therapy within 1 week, T-cell lysis antibodies within 8 weeks, monoclonal antibodies or ADC within 4 weeks, systemic glucocorticoids equivalent to >15 mg prednisone within 3 days, polyethylene glycol asparaginase within 4 weeks
- Vaccination with live attenuated, inactivated, or RNA vaccines within 4 weeks prior
- Allergies or intolerance to study drugs or infusion components including serious allergy history
- Significant cardiac diseases including NYHA class III/IV heart failure, uncontrolled arrhythmias, severe non-ischemic cardiomyopathy, or other concerning heart diseases
- Serious lung disease judged life-threatening
- Second primary malignant tumors requiring treatment or not fully resolved within 2 years, except certain low malignancy tumors
- Major surgery within 2 weeks prior or planned during study or within 4 weeks after treatment (excluding minor surgeries)
- History of organ transplantation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Actively Recruiting
Research Team
H
Heng Mei, M.D., Ph.D
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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