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ACTIVE NOT RECRUITING
NCT05973487
PHASE1

A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors

Sponsor: TScan Therapeutics, Inc.

View on ClinicalTrials.gov

Summary

TScan Therapeutics is developing cellular therapies across multiple solid tumors in which autologous participant-derived engeneered T cells are engineered to express a T cell receptor that recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA) molecules. This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in participants with locally advanced, metastatic solid tumors disease.

Official title: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants With Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

840

Start Date

2024-05-06

Completion Date

2026-12-30

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

TSC-204-A0201

Escalating doses of TSC-204-A0201 as a monotherapy

BIOLOGICAL

TSC-204-C0702

Escalating doses of TSC-204-C0702 as a monotherapy

BIOLOGICAL

TSC-200-A0201

Escalating doses of TSC-200-A0201 as a monotherapy

BIOLOGICAL

TSC-204-A0201 + TSC-204-C0702

Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702

BIOLOGICAL

TSC-204-A0201 + TSC-200-A0201

Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201

BIOLOGICAL

TSC-204-C0702 + TSC-200-A0201

Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201

BIOLOGICAL

TSC-204-A0201 + TSC-203-A0201

Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201

BIOLOGICAL

TSC-204-C0702 + TSC-203-A0201

Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201

BIOLOGICAL

TSC-200-A0201 + TSC-203-A0201

Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201

BIOLOGICAL

TSC-203-A0201

Escalating doses of TSC-203-A0201 as a monotherapy

BIOLOGICAL

TSC-204-A0101

Escalating doses of TSC-204-A0101 as a monotherapy

BIOLOGICAL

TSC-201-B0702

Escalating doses of TSC-201-B0702 as a monotherapy

BIOLOGICAL

TSC-204-A0201 + TSC-204-A0101

Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101

BIOLOGICAL

TSC-204-A0201 + TSC-201-B0702

Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702

BIOLOGICAL

TSC-204-C0702 + TSC-204-A0101

Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101

BIOLOGICAL

TSC-204-C0702 + TSC-201-B0702

Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702

BIOLOGICAL

TSC-200-A0201 + TSC-204-A0101

Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101

BIOLOGICAL

TSC-200-A0201 + TSC-201-B0702

Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702

BIOLOGICAL

TSC-203-A0201 + TSC-204-A0101

Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101

BIOLOGICAL

TSC-203-A0201 + TSC-201-B0702

Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702

BIOLOGICAL

TSC-202-A0201

Escalating doses of TSC-202-A0201 as a monotherapy

BIOLOGICAL

TSC-204-A0201 + TSC-202-A0201

Escalating doses of TSC-204-A0201 in combination with TSC-202-A0201

BIOLOGICAL

TSC-204-C0702 + TSC-202-A0201

Escalating doses of TSC-204-C0702 in combination with TSC-202-A0201

BIOLOGICAL

TSC-200-A0201 + TSC-202-A0201

Escalating doses of TSC-200-A0201 in combination with TSC-202-A0201

BIOLOGICAL

TSC-203-A0201 + TSC-202-A0201

Escalating doses of TSC-203-A0201 in combination with TSC-202-A0201

BIOLOGICAL

TSC-204-A0101 + TSC-202-A0201

Escalating doses of TSC-204-A0101 in combination with TSC-202-A0201

BIOLOGICAL

TSC-201-B0702 + TSC-202-A0201

Escalating doses of TSC-201-B0702 in combination with TSC-202-A0201

Locations (21)

HonorHealth Research and Innovation Institute

Scottsdale, Arizona, United States

University of California San Diego

San Diego, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Memorial Healthcare System

Hollywood, Florida, United States

University of Miami, Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Orlando Health

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

Norton Cancer Institute

Louisville, Kentucky, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, United States

Columbia University Herbert Irving Comprehensive Cancer Center

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Oncology Hematology Care

Cincinnati, Ohio, United States

The Cleveland Clinic

Cleveland, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

Allegheny Hospitals Network

Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States