Treatment for FLT3 Positive Acute Myeloid Leukemia using CAR T-cell Therapy
Pilot Study of the Safety and Efficacy of Anti-FLT3 Chimeric Antigen Receptor Engineered T-Cells in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia (AML)
This study is testing a new CAR T-cell therapy to see if it can help people aged 16-65 with FLT3 positive acute myeloid leukemia that hasn't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 5 (estimated) |
| Ages | 16 Years to 65 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Drugs / interventions | CART, chimeric antigen receptor, immunotherapy, CAR T |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT05023707 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of anti-FLT3 chimeric antigen receptor (CAR) T-cell immunotherapy in patients with FLT3 positive relapsed or refractory acute myeloid leukemia (AML). Participants aged 16-65 will receive infusions of engineered T-cells designed to target the FLT3 protein. The study is conducted in phases 1 and 2, focusing on assessing both the therapeutic effects and potential side effects of this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16-65 with FLT3 positive relapsed or refractory acute myeloid leukemia.
Not a fit: Patients who are pregnant, have uncontrolled infections, 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 difficult-to-treat FLT3 positive AML.
How similar studies have performed: Other studies using CAR T-cell therapy for various cancers have shown promising results, indicating potential success for this approach in AML as well.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * FLT3 positive relapsed/refractory acute myeloid leukemia * Age 16-65 years. * Left ventricular ejection fractions ≥ 0.5 by echocardiography * Creatinine \< 1.5x upper limit of normal. * Aspartate aminotransferase/aspartate aminotransferase ≤ 2.5x upper limit of normal * Total bilirubin ≤ 1.5x upper limit of normal * Karnofsky performance status ≥ 60 * Expected survival time ≥ 3 months (according to investigator's judgement) Exclusion Criteria: * Patients are pregnant or lactating * Uncontrolled active infection * Grade III/IV cardiovascular disability according to the New York Heart * Association Classification * Active hepatitis B or hepatitis C infection * Patients with HIV infection * Patients with a history of seizure * Patients with other contraindications considered unsuitable for participation in this study (according to investigator's judgement)
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: xwtang1020@163.com
- 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.