Genetically Modified T-cell Immunotherapy in Treating Patients With Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
Phase I Study of Cellular Immunotherapy Using T Cells Lentivirally Transduced to Express a CD123-Specific, Hinge-Optimized, CD28-Costimulatory Chimeric Antigen Receptor and a Truncated EGFR for Patients With CD123+ Relapsed/Refractory Acute Myeloid Leukemia and Persistent/Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
Doctors at the City of Hope Medical Center seek to enroll patients in a clinical trial to treat the following cancers:
- Adult Acute Myeloid Leukemia in Remission
- Acute Biphenotypic Leukemia
- Early Relapse of Acute Myeloid Leukemia
- Late Relapse of Acute Myeloid Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Secondary Acute Myeloid Leukemia
- Blastic Plasmacytoid Dendritic Cell Neoplasm
- Acute Myeloid Leukemia
- Adult Acute Lymphoblastic Leukemia
- Interleukin-3 Receptor Subunit Alpha Positive
- Minimal Residual Disease
- Refractory Acute Myeloid Leukemia
- Untreated Adult Acute Myeloid Leukemia
The investigatory treatment, a gene-modified immunotherapy, can treat the listed cancers by withdrawing immune T-cells from the patient and, utilizing gene editing, the white blood cells will be trained to target their cancer cells. Then the modified T-cells will be infused to the patient after a course of chemotherapy. If their disease has not responded after 28 days, they can receive a second infusion of the T-cells. Follow-up to track the progress of the tumors through lab assessments, MRI, and physical assessments will be required for ~6 weeks, and less frequent follow up will be required for up to 15 years.
- Be 12 years of age and older
- Be diagnosed with one of the eligible cancers, with DNA tests to confirm subtype required
- Have a life expectancy of at least 16 weeks at time of enrollment
- Agree to contraception for at least 6 months after the immunotherapy
- Be HIV negative
THE STUDY INVOLVES:
- Prescreening tests to confirm eligibility of the patient to participate.
- Have blood drawn, immune cells separated and blood cells returned (leukapheresis)
- After lab modification time, the patient will be admitted to the hospital and receive chemotherapy over 3 to 5 days.
- A few days later, the gene-edited immune cells will be infused and drugs to help promote their growth injected.
- Recovery in the hospital.
- A second infusion at 28 weeks if no disease response.
- After completion of study treatment, patients are followed up at 24 hours, then every 2 days for up to 14 days, every week for 1 month, every month for 1 year and then yearly for 15 years.
LOCATIONS AND CONTACTS:
The study site is at the City of Hope Medical Center in Duarte, California. Map.
Contact: Lihua E. Budde | 800-826-4673 | [email protected]
The National Cancer Institute (NCI)
Or go online: