CAR-T cell therapy for relapsed/refractory CD19+ acute lymphoblastic leukemia
Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
This study is testing if a new version of CAR-T cell therapy can help people with tough-to-treat CD19+ acute lymphoblastic leukemia feel better compared to the standard treatment.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 6 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, CAR-T |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT03275493 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of CD19 CAR-T cells in patients with relapsed or refractory CD19+ acute lymphoblastic leukemia. Participants are randomly assigned to receive either standard CD19 CAR-T cells or CD19 CAR-T cells enhanced with CRS suppression technology. The study aims to determine which treatment approach provides better outcomes for patients. It is conducted at a single center and includes both Phase 1 and Phase 2 assessments.
Who should consider this trial
Good fit: Ideal candidates are patients aged 6 to 65 with relapsed or refractory CD19+ acute lymphoblastic leukemia who are ineligible for allo-HSCT.
Not a fit: Patients with uncontrolled infections, active hepatitis, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and quality of life for patients with difficult-to-treat leukemia.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 6 to 65 2. Voluntary informed consent is given 3. Expected survival ≥12 weeks 4. Relapsed or refractory CD19+ acute leukemia, ineligible for allo-HSCT,or relapse after auto-HSCT 5. Organ function: (1)Left ventricular ejection fractions≥ 0.6 by echocardiography (2)ALT ≤3 times of ULN, or bilirubin \<2.0 mg/dl (3)Creatinine \< 2 mg/dl and less than 2.5 × normal for age (4)Prothrombin time and activated partial thromboplastin time \< 2 times of ULN (5)Arterial oxygen saturation\> 92% 6. Karnofsky score ≥ 60 ; 7. No history of combined chemotherapy in the recent 1 month and no immunotherapy in the recent 3 months; Exclusion Criteria: 1. Uncontrolled active infections 2. Active hepatitis B or hepatitis C infection 3. HIV infection 4. History of myocardio infarction in the past 6 months, or history of severe arrhythmia 5. Congenital immunodeficiency 6. Pregnant or lactating women 7. History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis 8. Previous treatment with any gene therapy products
Where this trial is running
Suzhou, Jiangsu
- The first affiliated hospital of soochow university — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xiaowen Tang, PhD — The First Affiliated Hospital of Soochow University
- Study coordinator: Xiaowen Tang, PhD
- Email: tangxiaowen@suda.edu.cn
- Phone: 8651267781525
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.