Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

January 28, 2015

Primary Completion Date

November 30, 2021

Study Completion Date

November 29, 2021

Conditions
Acute Lymphoblastic LeukemiaComplete Hematologic Remission (CHR)Persistent/Recurrent Minimal Residual Disease (MRD)
Interventions
OTHER

Autologous NK cells infusions

"Each patient will receive repeated intravenous (IV) infusions of escalating doses of expanded autologous NK cells.~The initial dose will be 1 x 106/kg of recipient body weight (BW), followed by half log increments of the dose level for each infusion, to a maximum of 1 x 108/kg of recipient BW or until they experience any toxicity, for a maximum of 5 infusions. The minimum interval between each infusion will be 28 days. No conditioning therapies will be administered before the infusion of the expanded NK cells. Patients may receive TKI maintenance."

Trial Locations (6)

Unknown

ISS/AIFA, Roma

Ospedale S. Eugenio, Roma

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli, Roma

"Università degli Studi Sapienza - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia", Roma

Università degli Studi - Policlinico di Tor Vergata, Roma

"Università Degli Studi Di Roma Sapienza - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia", Roma

All Listed Sponsors
lead

Gruppo Italiano Malattie EMatologiche dell'Adulto

OTHER

NCT02185781 - Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL) | Biotech Hunter | Biotech Hunter