A Controlled Multi-Arm Phase 1 Umbrella Study Evaluating the Safety and Feasibility of T-Cell Receptor Engineered Donor T-Cells Targeting HA1 (TSC-100) or HA2 (TSC-101) in HLA-A0201 Positive Patients Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

TScan Therapeutics, Inc.

Summary

This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD

Description

A multi-center, non-randomized, controlled, multi-arm, Phase 1 interventional, open label, biologic assignment-based umbrella study is planned to evaluate the feasibility, safety, and preliminary efficacy of repeated dose regimen of TSC-100 and TSC-101 (TSC-100 and TSC-101 is a genetically engineered, donor-derived T cell targeting HA-1 and HA-2 respectively) in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MUD, or MMUD. The primary objective of this study is to investigate the safety of single and repeated dosing of TSC-100 and TSC-101 in HLA A\*02:01 positive pat…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Male or female aged ≥ 18 years at the time of signing the informed consent. * Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit. * Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * Male Participants: * A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention…

Interventions

Drug
SOC + TSC-100
HA-1 positive
Drug
SOC + TSC-101
HA-2 positive or HA-1 negative
Other
Control
SOC alone

Locations (15)

City of Hope
Duarte, California
Yale
New Haven, Connecticut
Memorial Healthcare System
Hollywood, Florida
Northside Hospital
Atlanta, Georgia
John Hopkins University
Baltimore, Maryland
Mass General Hospital
Boston, Massachusetts