CAR-T therapy for treating acute myeloid leukemia with specific genetic markers
Giving CAR-T CD19 Transgenic T Cells for Acute Myeloid Leukemia Patients (AML) With t 8:21 and CD19 Expression
This study is testing a new CAR-T therapy for people with tough-to-treat acute myeloid leukemia who have certain genetic markers to see if it can help them when other treatments have failed.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sheba Medical Center Government |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine, CAR-T, Chimeric antigen receptor |
| Locations | 1 site (Ramat Gan) |
| Trial ID | NCT04257175 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of CAR-T CD19 engineered T cells for patients with recurrent acute myeloid leukemia (AML) who have not responded to standard treatments. The study focuses on patients with specific genetic characteristics, such as t(8;21) and CD19 expression, to assess the efficacy of this innovative therapy. Participants will receive CAR-T CD19 treatment after exhausting other approved therapies, including chemotherapy and FLT3 inhibitors. The goal is to determine the safety and effectiveness of this approach in a challenging patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with recurrent AML who have not responded to previous therapies and have specific genetic markers.
Not a fit: Patients with active infections, severe heart disease, or those currently enrolled in other studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat acute myeloid leukemia.
How similar studies have performed: While CAR-T therapies have shown success in treating other types of leukemia, this specific application for AML is relatively novel and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with recurrent acute myeloid leukemia (AML) including those after bone marrow transplantation or not responding to previous therapy, who have exhausted other approved relevant therapies such as chemotherapy protocols that are ineffective and with high toxicity, or FLT3 inhibitors in patients with FLT3 . Exclusion Criteria: * Heart disease including severe heart failure (NYHA III-IV), recent MI or CABG surgery (in previous six months), severe ventricular rhythm abnormalities, non ischemic heart disease, LVEF less than 45% * Active involvement of CNS * Active infection * Pregnancy or lactation * Graft versus host disease III-IV grade - Stroke or seizure in the last six months before treatment * A positive result for the HIV infection (serum) * Active hepatitis infection * Life-threatening allergies to cyclophosphamide or fludarabine * No informed consent signed by candidate * Candidate enrolled in other study
Where this trial is running
Ramat Gan
- Chaim Sheba Medical Center — Ramat Gan, Israel (Recruiting)
Study contacts
- Study coordinator: Arnon Nagler, MD
- Email: Arnon.Nagler@sheba.health.gov.il
- Phone: +972-3-530 5830
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.