CD19 CAR-T therapy for treating acute lymphoblastic leukemia
Evaluation of Safety and Efficacy of CD19 CAR-T Consolidation Therapy for Acute Lymphoblastic Leukemia Concomitant With Infusion of CD19+T Cells as Feeding Cells
This study is testing a new CAR-T therapy combined with special T cells to see if it can help people with a specific type of leukemia feel better and stay healthy longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT03984968 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of CD19 CAR-T therapy combined with feeding T cells (FTCs) as a consolidation treatment for patients with de novo Philadelphia chromosome positive CD19+ B-ALL. The study involves several phases, including screening, lymphocyte apheresis, and chemotherapy, followed by multiple cycles of CAR-T infusion. The FTCs are designed to stimulate the expansion and persistence of the CAR-T cells in the body. The trial aims to determine the optimal dosing of FTCs while ensuring patient safety and efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates include patients with Philadelphia chromosome positive acute B-lymphoblastic leukemia who are not eligible for allogeneic stem cell transplantation.
Not a fit: Patients with mutations on the abl gene or those resistant to TKI medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve treatment outcomes for patients with acute lymphoblastic leukemia.
How similar studies have performed: Other studies have shown promise with CAR-T therapies in similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ph+ acute B-lymphoblastic leukemia patients * continuously taking TKI medications * no chance to receive allogeneic hematopoietic stem cell transplantation * no severe complications * ECOG score less than 3 Exclusion Criteria: * Detection of mutations on abl gene * resistance to TKI medications
Where this trial is running
Suzhou, Jiangsu
- The First Affliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Sheng-Li Xue, M.D.
- Email: slxue@suda.edu.cn
- Phone: +86 512 67781139
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.