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

Status: Recruiting
Location: See all (15) locations...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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 and refrain from donating sperm during this period.

• Female Participants:

• A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:

• Not a woman of childbearing potential (WOCBP) OR

• A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.

• Preparing to undergo allogeneic HCT for either of the following:

• AML

• MDS

• ALL

• Participants in the treatment arms must express HLA-A\*0201. Participants in the control arm may express any HLA type.

• Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.

• Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.

• Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor inclusion criteria.

• Considered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.

• Considered to be clinically indicated for RIC at the discretion of the treating investigator.

• Considered to be clinically indicated for peripheral blood stem cell transplantation at the discretion of the treating investigator.

• Organ function parameters for transplant eligibility are met per institutional standards.

• Capable of giving signed informed consent - which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

• Participants must provide consent for mandatory study procedures including bone marrow biopsy and blood sampling for research analyses in the ICF.

• Participants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational Tcell infusion.

⁃ Donor Inclusion Criteria :

• Male or female aged ≥ 18 years at the time of signing the informed consent.

• Able to undergo peripheral blood stem cell (PBSC) collection and up to 2 rounds of leukapheresis (for TSC-100 or TSC101 manufacturing for treatment arms only, and f for stem cell collection for both treatment arms and the control arm).

• Donors matched to TSC-100 participants should be HA-1-/- (negative) and/or negative for all HLA-A\*02 alleles

• Donors matched to TSC-101 participants should be negative for all HLA-A\*02 alleles

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Locations
United States
California
City of Hope
RECRUITING
Duarte
Connecticut
Yale
RECRUITING
New Haven
Florida
Memorial Healthcare System
RECRUITING
Hollywood
Georgia
Northside Hospital
RECRUITING
Atlanta
Massachusetts
Mass General Hospital
RECRUITING
Boston
Maryland
John Hopkins University
RECRUITING
Baltimore
Michigan
Karmanos Cancer Institute
RECRUITING
Detroit
North Carolina
University North Carolina
RECRUITING
Chapel Hill
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
New York
Columbia University
RECRUITING
New York
Mount Sinai
RECRUITING
New York
Pennsylvania
UPenn
RECRUITING
Philadelphia
Texas
Baylor University Medical Center
RECRUITING
Dallas
MD Anderson
RECRUITING
Houston
Wisconsin
Froedert and Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Jim Murray
medicalaffairs@tscan.com
8573999500
Time Frame
Start Date: 2022-11-01
Estimated Completion Date: 2026-06
Participants
Target number of participants: 75
Treatments
Experimental: TSC-100 Treatment Arm
HA-1 positive patients
Experimental: TSC 101 Treatment Arm
HA-1 negative and HA-2 positive patients
Active_comparator: Standard of Care or Control arm
Sponsors
Leads: TScan Therapeutics, Inc.

This content was sourced from clinicaltrials.gov