Study of CAR T-cell Therapy in Acute Myeloid Leukemia and Multiple Myeloma

Phase 1/2 Terminated 8 enrolled AGC Biologics S.p.A. Horizon 2020 - European Commission · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this first-in-man Phase I-IIa study is to evaluate the safety and antitumor activity of autologous CD44v6 CAR T-cells in patients with acute myeloid leukemia (AML) and multiple myeloma (MM).

Timeline

Start: 2019-08-27
Primary completion: 2021-06-18
Completion: 2021-06-18

Outcome

Outcome not reported

Stopped: “Inability to close the study in a clinically relevant time frame”

Publications

Stornaiuolo A, Valentinis B, Sirini C, Scavullo C, Asperti C, Zhou D, Martinez De La Torre Y, Corna S, Casucci M, Porcellini S, Traversari C. Characterization and Functional Analysis of CD44v6.CAR T Cells Endowed with a New Low-Affinity Nerve Growth Factor Receptor-Based Spacer. Hum Gene Ther. 2021 Jul;32(13-14):744-760. doi: 10.1089/hum.2020.216. Epub 2021 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MLM-CAR44.1 T-cells	Cell therapy	500000 cells/kg	Intravenous
Subject	MLM-CAR44.1 T-cells	Cell therapy	1e+06 cells/kg	Intravenous
Subject	MLM-CAR44.1 T-cells	Cell therapy	2e+06 cells/kg	Intravenous
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	—
Background	Fludarabine	Small molecule	30 mg/m2	—