Targeted T Cell Therapy for Acute Myeloid Leukemia
Pilot Study of the Efficacy and Safety of CD19 Targeted Chimeric Antigen Receptor Engineered T Cell in the Treatment of Relapsed or Refractory CD19 Positive Acute Myeloid Leukemia (AML)
This study is testing a new type of immune therapy called CART-19 to see if it can help people with a specific kind of leukemia that hasn't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (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, Jiangsu) |
| Trial ID | NCT03896854 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of CART-19, a chimeric antigen receptor engineered T cell immunotherapy, in patients with CD19 positive relapsed or refractory acute myeloid leukemia. Participants will receive infusions of CART cells specifically designed to target CD19, with the aim of improving treatment outcomes. The study is conducted at a single center and includes both phase 1 and phase 2 assessments to gather comprehensive data on the therapy's performance.
Who should consider this trial
Good fit: Ideal candidates are male or female patients aged 6-65 with CD19 positive relapsed or refractory acute myeloid leukemia.
Not a fit: Patients with uncontrolled infections, active hepatitis, or significant cardiovascular issues may not benefit from this therapy.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat acute myeloid leukemia.
How similar studies have performed: Other studies using CAR T cell therapies have shown promising results in similar conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia * 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, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, 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.