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

Part of paid clinical trials in Duarte, California.

Sponsor
TScan Therapeutics, Inc.
Study ID
NCT05473910
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

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

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

First listed
Jul 26, 2022
Start date
Nov 1, 2022
Status verified
Jul 2026
Primary completion
Jun 1, 2026
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Treatment Arm (TSC-100)
    HA-1 positive patients
  • Experimental: Treatment Arm (TSC-101)
    HA-1 negative and HA-2 positive patients
  • Active Comparator: Control Arm (Standard of Care)
    Other: Control SOC alone

Primary Outcome Measure

Occurrence of dose limiting toxicities [ Time Frame: 2 years ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Monzr Al Malki, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado - Anschutz Cancer CenterAuroraColorado80045
Mathew Angelos, MD (PRINCIPAL_INVESTIGATOR)
SCRI - Colorado Blood Cancer InstituteDenverColorado80218
Marcello Rotta, MD (PRINCIPAL_INVESTIGATOR)
YaleNew HavenConnecticut06510
Lohith Gowda, MD (PRINCIPAL_INVESTIGATOR)
Memorial Cancer InstituteHollywoodFlorida33021
Hugo Fernandez, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer InstituteTampaFlorida33612
Nelli Bejanyan, MD (PRINCIPAL_INVESTIGATOR)
Northside HospitalAtlantaGeorgia30342
Melhem M Solh, MD (PRINCIPAL_INVESTIGATOR)
Johns Hopkins UniversityBaltimoreMaryland21287
Tania Jain, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute - Hematology/OncologyBostonMassachusetts02215
Mahasweta Gooptu, MD (PRINCIPAL_INVESTIGATOR)
Mass General HospitalBostonMassachusetts02114
Yi-Bin Chen, MD (PRINCIPAL_INVESTIGATOR)
Karmanos Cancer InstituteDetroitMichigan48201
Joseph Uberti, MD
Hackensack University Medical CenterHackensackNew Jersey07601
Michele Donato, MD
Columbia UniversityNew YorkNew York10027
Ran Reshef, MD
Mount SinaiNew YorkNew York10029-6696
Alla Keyzner, MD (PRINCIPAL_INVESTIGATOR)
University North CarolinaChapel HillNorth Carolina27599
Anson Snow, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Saar Gill, MD (PRINCIPAL_INVESTIGATOR)
SCRI - TriStar Bone Marrow TransplantNashvilleTennessee37203
Jeremy Pantin, MD (PRINCIPAL_INVESTIGATOR)
St. David's South Austin Medical CenterAustinTexas76704
Uttam Rao, MD (PRINCIPAL_INVESTIGATOR)
Baylor University Medical CenterDallasTexas75246
Luis Pineiro, MD (PRINCIPAL_INVESTIGATOR)
MD AndersonHoustonTexas77030
Uday Popat, MD (PRINCIPAL_INVESTIGATOR)
Froedert and Medical College of WisconsinMilwaukeeWisconsin53226
Sameem Abedin, MD
Sameem Abedin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAUniversity of Colorado - Anschutz Cancer Center· Aurora, COSCRI - Colorado Blood Cancer Institute· Denver, COYale· New Haven, CTMemorial Cancer Institute· Hollywood, FLMoffitt Cancer Institute· Tampa, FL

Related Studies