A Study of TSC-100 and TSC-101 in AML, ALL and MDS in Patients Undergoing Allogeneic Peripheral Blood Stem Transplantation

Part of paid clinical trials in Duarte, California.

Sponsor
TScan Therapeutics, Inc.
Study ID
NCT05473910
Phase
PHASE1
Status
Recruiting
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Conditions

  • ALL, Adult
  • AML
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SOC + TSC-100 — DRUG
    HA-1 positive
  • SOC + TSC-101 — DRUG
    HA-2 positive or HA-1 negative
  • Control — OTHER
    SOC alone

Study Details

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

Key Dates

Start date
Nov 1, 2022
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
75 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Occurrence of dose limiting toxicities [ Time Frame: two years ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Monzr M Al Malki, MD
YaleNew HavenConnecticut06510
Iris Isufi, MD
Memorial Healthcare SystemHollywoodFlorida33021
Hugo Fernandez, MD
Northside HospitalAtlantaGeorgia30342
Melholm Sohl, MD
John Hopkins UniversityBaltimoreMaryland21287
Tania Jain, MD
Mass General HospitalBostonMassachusetts02114
Yi-Bin Chen, MD
Karmanos Cancer InstituteDetroitMichigan48201
Joseph Uberti, MD
Hackensack University Medical CenterHackensackNew Jersey07601
Hyung Suh, MD
Columbia UniversityNew YorkNew York10027
Ran Reshef, MD
Mount SinaiNew YorkNew York10029-6696
Alla Keyzner, MD
University North CarolinaChapel HillNorth Carolina27599
Anson Snow, MD
UPennPhiladelphiaPennsylvania19104
Saar Gill, MD
Baylor University Medical CenterDallasTexas75246
Luis Pineiro, MD
MD AndersonHoustonTexas77030
Uday Popat, MD
Froedert and Medical College of WisconsinMilwaukeeWisconsin53226
Sameem Abedin, MD

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City of Hope· Duarte, CAYale· New Haven, CTMemorial Healthcare System· Hollywood, FLNorthside Hospital· Atlanta, GAJohn Hopkins University· Baltimore, MDMass General Hospital· Boston, MA

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