Targeted T Cell Therapy for B-Cell Acute Lymphoblastic Leukemia
Pilot Study of the Efficacy and Safety of Cluster of Differentiation Antigen 19 (CD19) /Cluster of Differentiation Antigen 22 (CD22) CART in the Treatment of Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia.
This study is testing a new type of immune therapy that uses specially engineered T cells to see if it can help people aged 6 to 65 with hard-to-treat B-cell acute lymphoblastic leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 6 Years to 65 Years |
| Sex | All |
| Sponsor | Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd Industry-sponsored |
| Drugs / interventions | CART, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Suzhou) |
| Trial ID | NCT03614858 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of chimeric antigen receptor engineered T cell immunotherapy targeting CD19 and CD22 in patients with relapsed or refractory B-cell acute lymphoblastic leukemia. Patients aged 6 to 65 years will receive infusions of CART cells specifically designed to attack CD19 and CD22 positive leukemia cells. The study aims to enroll 20 patients and will assess their response to the treatment over time. It is an open-label, single-center study that combines both Phase 1 and Phase 2 methodologies.
Who should consider this trial
Good fit: Ideal candidates are male or female patients aged 6-65 with CD19+/CD22+ relapsed or refractory B-cell acute lymphoblastic leukemia.
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 therapy could provide a new treatment option for patients with a poor prognosis due to relapsed or refractory B-cell acute lymphoblastic leukemia.
How similar studies have performed: Other studies utilizing CAR T-cell therapies have shown promising results in treating similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients with CD19+/CD22+ relapsed/refractory B-cell acute lymphoblastic leukemia who have a dismal prognosis (estimated survival from several months to \<2 year). The study will enroll 20 evaluable patients as follows: * Age 6-65 years. * Left ventricular ejection fractions≥ 0.5 by echocardiography. * Creatinine \< 1.6 mg/dL. * Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal. * Bilirubin \<2.0 mg/dL. * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: * Pregnant or lactating women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Class III/IV cardiovascular disability according to the New York Heart Association Classification. * HIV infection. * Patients with history of seizure * Active central nervous system leukemia
Where this trial is running
Suzhou
- The First Affiliated Hospital of Soochow University — Suzhou, China (Recruiting)
Study contacts
- Principal investigator: Xiaowen Tang, Ph.D. — The First Affiliated Hospital of Soochow University
- Study coordinator: Xiaowen Tang, Ph.D.
- Email: tangxiaowen@suda.edu.cn
- Phone: (0086)51267781856
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.