Using CD19 CAR-T cells and feeder T cells to treat leukemia
CD19 Chimeric Antigen Receptors and CD19 Positive Feeder T Cells as a Leukemia Consolidation Treatment
This study is testing a new treatment using special immune cells to see if it helps people with leukemia stay in remission longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd Industry-sponsored |
| Drugs / interventions | chemotherapy, immunotherapy, CAR-T, Chimeric Antigen Receptor, cyclophosphamide, fludarabine |
| Locations | 3 sites (Suzhou, Jiangsu and 2 other locations) |
| Trial ID | NCT05381662 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a novel treatment combining CD19 chimeric antigen receptor (CAR-T) T cells with CD19 positive feeder T cells for patients with acute lymphoblastic leukemia who are in remission. Participants are divided into two groups: one receiving the treatment without any pretreatment and the other receiving cyclophosphamide and fludarabine prior to the CAR-T cell infusion. The study aims to determine the effectiveness of this approach in consolidating remission in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with CD19 positive acute lymphoblastic leukemia in remission and adequate organ function.
Not a fit: Patients with uncontrolled infections, active hepatitis, or significant cardiovascular issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve remission rates and overall outcomes for patients with acute lymphoblastic leukemia.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age 18 to 65 2. Voluntary informed consent is given 3. Expected survival ≥12 weeks 4. Relieve CD19+ acute leukemia 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 and 2 other locations
- The first affiliated hospital of soochow university — Suzhou, Jiangsu, China (Recruiting)
- The first affiliated hospital of soochow university — Suzhou, Jiangsu, China (Recruiting)
- The First Affiliated Hospital of Soochow University — Suzhou, China (Recruiting)
Study contacts
- Study coordinator: Depei Wu, Ph.D
- 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.