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RecruitingPhase 1NCT05473910

A Phase 1/3 Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)

A Phase 1/3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)

Sponsor

TScan Therapeutics, Inc.

Enrollment

310 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

AMLMDS

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two experimental cancer vaccines (TSC-100 and TSC-101) to see if they can prevent relapse after an allogeneic stem cell transplant (receiving stem cells from a donor) in patients with leukemia (AML or ALL) or a pre-leukemia condition called MDS. **You may be eligible if...** - You are 18 or older and have been diagnosed with AML (acute myeloid leukemia), ALL (acute lymphoblastic leukemia), or MDS (myelodysplastic syndrome) - You are planning to undergo an allogeneic stem cell transplant (from a donor) - You carry specific genetic markers (HLA-A*0201 and HA-1 or HA-2 positive genotype) that are needed for the vaccines to work **You may NOT be eligible if...** - You do not carry the required genetic markers for the vaccine - You have uncontrolled active infections - You have significant organ damage that would make transplant too risky - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSOC + TSC-101

HA-2 positive or HA-1 negative

OTHERControl

SOC alone

DRUGSOC + TSC-100

HA-1 positive

Locations(21)

City of Hope

Duarte, California, United States

University of Colorado - Anschutz Cancer Center

Aurora, Colorado, United States

SCRI - Colorado Blood Cancer Institute

Denver, Colorado, United States

Yale

New Haven, Connecticut, United States

Memorial Cancer Institute

Hollywood, Florida, United States

Moffitt Cancer Institute

Tampa, Florida, United States

Northside Hospital

Atlanta, Georgia, United States

Johns Hopkins University

Baltimore, Maryland, United States

Mass General Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute - Hematology/Oncology

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Columbia University

New York, New York, United States

Mount Sinai

New York, New York, United States

University North Carolina

Chapel Hill, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

SCRI - TriStar Bone Marrow Transplant

Nashville, Tennessee, United States

St. David's South Austin Medical Center

Austin, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

MD Anderson

Houston, Texas, United States

Froedert and Medical College of Wisconsin

Milwaukee, Wisconsin, United States

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NCT05473910

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