CAR-T therapy for treating B-cell leukemia in the central nervous system
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
PHASE1 · Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · NCT03064269
This study is testing a new CAR-T therapy to see if it can help young people with B-cell leukemia in the central nervous system fight the cancer more effectively.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 10 Years to 60 Years |
| Sex | All |
| Sponsor | Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd (industry) |
| Drugs / interventions | CAR-T, Chimeric antigen receptor |
| Locations | 1 site (Suzhou) |
| Trial ID | NCT03064269 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Chimeric Antigen Receptor T cells (CAR-T) specifically targeting CD19 in patients with central nervous system B-cell acute lymphocytic leukemia. The trial aims to determine how well these engineered T cells can combat leukemia cells that have infiltrated the central nervous system. Participants will be monitored for both the effectiveness of the treatment and any potential side effects. The study is designed for patients aged 10 to 60 who meet specific health criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 10 to 60 with CD19 positive central nervous system B-cell acute lymphocytic leukemia.
Not a fit: Patients with active infections, certain viral infections, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with a challenging form of leukemia that affects the central nervous system.
How similar studies have performed: Other studies using CAR-T therapy for hematological malignancies have shown promising results, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia 2. ALT/ AST 《 3x normal 3. Creatinine 《 3x normal 4. Age:10-60. 5. Signed informed consent Exclusion Criteria: 1. Active hepatitis B , hepatitis C or HIV infection 2. Uncontrolled active infection 3. Pregnancy or breast-feeding women 4. Survival less than four weeks
Where this trial is running
Suzhou
- The First Affiliated Hospital of Soochow University — Suzhou, China (RECRUITING)
Study contacts
- Principal investigator: Sheng-Li Xue, Ph.D — The First Affiliated Hospital of Soochow University
- Study coordinator: Sheng-Li Xue, MD
- Email: slxue@suda.edu.cn
- Phone: 86-13328008851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: B-cell Acute Lymphocytic Leukemia, CNS B cell acute lymphocytic leukemia