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Clinical Trial Finder

Search Results

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Must be at least 18 years. 2. Locally advanced (unresectable) or metastatic solid tumor for which there are no available curative treatment options, after failure of the standard of care systemic therapies for that particular indication. 3. Solid tumors, including but not limited to non-nasopharyngeal head and neck cancer, non-small cell lung cancer, cutaneous melanoma, cervical cancer, ovarian cancer, anal cancer and genital cancers. Other tumor types may be permitted if approved by TScan. 4. Participants must express one of the following HLA types, as assessed by a qualified genomics assay in screening study TSCAN-003: HLA-B*07:02, HLA-A*01:01, HLA-C*07:02 and/or HLA-A*02:01. 5. Tumor must express one or more of the following: MAGE-A1, MAGE-A4, MAGE-C2, PRAME and HPV16 assessed in the last 8 months in screening study TSCAN-003 (NCT05812027). 6. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening. 7. Participants must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative. 8. At least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. 9. Adequate bone marrow and organ function.

Exclusion Criteria:

1. Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI. 2. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, cardiac arrhythmia requiring antiarrhythmic or procedure, or other clinically significant cardiac disease within 12 months of enrollment. 3. Have a history of ASTCT Grade 4 CRS, Grade 3 or greater ICANS, or Grade 3 or greater IECHS. Participants with a history of lower grade CRS, ICANS, or IECHS may be eligible, pending review and approval by the Medical Monitor. 4. History of stroke or transient ischemic attack (TIA) within 6 months of enrollment. 5. Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7 days of enrollment. 6. History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte. 7. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis. 8. Concurrent receipt of another anti-cancer therapy. Have a history of acute mental status changes of unknown etiology within 6 months prior to enrollment, or any neurological or neurodegenerative disorder (e.g., Parkinson disease, Huntington disease, uncontrolled seizure disorder) that may increase the risk for or confound the assessment of neurotoxicity. 9. Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management. 10. Tumors that have HLA LOH using a central lab clinical trial assay of HLAs addressed by the monotherapy and/or T-Plex combination TCR-Ts in the protocol and have no available TCR-T options for intact HLAs in the participant's tumor. 11. Participants who regularly require supplemental oxygen.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05973487
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

TScan Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Dawn Pinchasik, MD
Principal Investigator Affiliation TScan Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Head and Neck Cancer, Cervical Cancer, Non-small Cell Carcinoma, Melanoma, Ovarian Cancer, Anogenital Cancers, HPV - Anogenital Human Papilloma Virus Infection, HPV-Related Cervical Carcinoma, HPV-Related Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Malignancy, HPV-Related Adenocarcinoma, HPV Positive Oropharyngeal Squamous Cell Carcinoma, HPV-Related Adenosquamous Carcinoma, HPV-Associated Vaginal Adenocarcinoma, HPV-Related Endocervical Adenocarcinoma, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Verrucous Carcinoma, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV Positive Rectal Squamous Cell Carcinoma
Additional Details

Participants will be screened in a separate screening study, TSCAN-003 (NCT05812027), to assess their HLA type, tumor-associated antigen (TAA) expression and loss of heterozygosity (LOH) status. The results of these tests will be used to determine initial eligibility in this study. Depending on the genetic type, participants will be assigned to one of the following study groups: Monotherapy:

  • - COHORT A: TSC-204-A0201 targeting MAGE-A1 on HLA-A*02:01.
  • - COHORT B: TSC-204-C0702 targeting MAGE-A1 on HLA-C*07:02.
  • - COHORT C: TSC-200-A0201 targeting HPV16 E7 on HLA-A*02:01.
  • - COHORT D: TSC-203-A0201 targeting PRAME on HLA-A*02:01.
  • - COHORT E: TSC-204-A0101 targeting MAGE-A1 on HLA-A*01:01.
  • - COHORT F: TSC-201-B0702 targeting MAGE-C2 on HLA-B*07:02.
  • - COHORT G: TSC-202-A0201 targeting MAGE-A4 on HLA-A*02:01.
T-Plex Combination:
  • - COHORT AB: TSC-204-A0201 + TSC-204-C0702.
  • - COHORT AC: TSC-204-A0201 + TSC-200-A0201.
  • - COHORT AD: TSC-204-A0201 + TSC-203-A0201.
  • - COHORT AE: TSC-204-A0201 + TSC-204-A0101.
  • - COHORT AF: TSC-204-A0201 + TSC-201-B0702.
  • - COHORT BC: TSC-204-C0702 + TSC-200-A0201.
  • - COHORT BD: TSC-204-C0702 + TSC-203-A0201.
  • - COHORT BE: TSC-204-C0702 + TSC-204-A0101.
  • - COHORT BF: TSC-204-C0702 + TSC-201-B0702.
  • - COHORT CD: TSC-200-A0201 + TSC-203-A0201.
  • - COHORT CE: TSC-200-A0201 + TSC-204-A0101.
  • - COHORT CF: TSC-200-A0201 + TSC-201-B0702.
  • - COHORT DE: TSC-203-A0201 + TSC-204-A0101.
  • - COHORT DF: TSC-203-A0201 + TSC-201-B0702.
  • - COHORT EF: TSC-204-A0101 + TSC-201-B0702.
  • - COHORT AG: TSC-204-A0201 + TSC-202-A0201.
  • - COHORT BG: TSC-204-C0702 + TSC-202-A0201.
  • - COHORT CG: TSC-200-A0201 + TSC-202-A0201.
  • - COHORT DG: TSC-203-A0201 + TSC-202-A0201.
  • - COHORT EG: TSC-204-A0101 + TSC-202-A0201.
  • - COHORT FG: TSC-201-B0702 + TSC-202-A0201.
Participants will undergo leukapheresis to collect cells to manufacture the TCR-T products. They will then undergo lymphodepletion and receive one or two doses of the TCR-T cell therapy product as a monotherapy or part of a combination of TCR-Ts (referred to as T-Plex combinations in this study).

Arms & Interventions

Arms

Experimental: Monotherapy Cohort A

TSC-204-A0201

Experimental: Monotherapy Cohort B

TSC-204-C0702

Experimental: Monotherapy Cohort C

TSC-200-A0201

Experimental: T-Plex Combination Cohort A + B

TSC-204-A0201 and TSC-204-C0702

Experimental: T-Plex Combination Cohort B + C

TSC-204-C0702 and TSC-200-A0201

Experimental: T-Plex Combination Cohort A + C

TSC-204-A0201 and TSC-200-A0201

Experimental: Monotherapy Cohort D

TSC-203-A0201

Experimental: T-Plex Combination Cohort A + D

TSC-204-A0201 + TSC-203-A0201

Experimental: T-Plex Combination Cohort B + D

TSC-204-C0702 + TSC-203-A0201

Experimental: Monotherapy Cohort E

TSC-204-A0101

Experimental: Monotherapy Cohort F

TSC-201-B0702

Experimental: T-Plex Combination Cohort A + E

TSC-204-A0201 + TSC-204-A0101

Experimental: T-Plex Combination Cohort A + F

TSC-204-A0201 + TSC-201-B0702

Experimental: T-Plex Combination Cohort B + E

TSC-204-C0702 + TSC-204-A0101

Experimental: T-Plex Combination Cohort B + F

TSC-204-C0702 + TSC-201B0702

Experimental: T-Plex Combination Cohort C + D

TSC-200-A0201 + TSC-203-A0201

Experimental: T-Plex Combination Cohort C + E

TSC-200-A0201 + TSC-204-A0101

Experimental: T-Plex Combination Cohort C + F

TSC-200-A0201 + TSC-201B0702

Experimental: T-Plex Combination Cohort D + E

TSC-203-A0201 + TSC-204A0101

Experimental: T-Plex Combination Cohort D + F

TSC-203-A0201 + TSC-201B0702

Experimental: T-Plex Combination Cohort E + F

TSC-204-A0101 + TSC-201-B0702

Experimental: Monotherapy Cohort G

TSC-202-A0201

Experimental: T-Plex Combination Cohort A + G

TSC-204-A0201 + TSC-202-A0201

Experimental: T-Plex Combination Cohort B + G

TSC-204-C0702 + TSC-202-A0201

Experimental: T-Plex Combination Cohort C+ G

TSC-200-A0201 + TSC-202-A0201

Experimental: T-Plex Combination Cohort D + G

TSC-203-A0201 + TSC-202-A0201

Experimental: T-Plex Combination Cohort E + G

TSC-204-A0101 + TSC-202-A0201

Experimental: T-Plex Combination Cohort F + G

TSC-201-B0702 + TSC-202-A0201

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Scottsdale 5313457, Arizona 5551752

Status

Recruiting

Address

HonorHealth Research and Innovation Institute

Scottsdale 5313457, Arizona 5551752, 85258

Site Contact

Justin Moser, MD

[email protected]

480-323-1364

University of California San Diego, San Diego 5391811, California 5332921

Status

Recruiting

Address

University of California San Diego

San Diego 5391811, California 5332921, 92037

Site Contact

Jasmine Cate

[email protected]

858-246-3035

Yale Cancer Center, New Haven 4839366, Connecticut 4831725

Status

Recruiting

Address

Yale Cancer Center

New Haven 4839366, Connecticut 4831725, 06510

Site Contact

Jialing Zhang

[email protected]

475-234-9684

Memorial Healthcare System, Hollywood 4158928, Florida 4155751

Status

Recruiting

Address

Memorial Healthcare System

Hollywood 4158928, Florida 4155751, 33021

Site Contact

Brian Pico, MD

[email protected]

954-265-1847

Miami 4164138, Florida 4155751

Status

Recruiting

Address

University of Miami, Sylvester Comprehensive Cancer Center

Miami 4164138, Florida 4155751, 33136

Site Contact

Marialby Donis Ramos

[email protected]

305-243-1000

Orlando Health, Orlando 4167147, Florida 4155751

Status

Recruiting

Address

Orlando Health

Orlando 4167147, Florida 4155751, 32806

Site Contact

Melinda Porter

[email protected]

321-841-7246

University of South Florida, Tampa 4174757, Florida 4155751

Status

Recruiting

Address

University of South Florida

Tampa 4174757, Florida 4155751, 33606

Site Contact

Monica Rengifo Pardo

[email protected]

857-399-9887

University of Chicago, Chicago 4887398, Illinois 4896861

Status

Recruiting

Address

University of Chicago

Chicago 4887398, Illinois 4896861, 60637

Site Contact

Stephanie Farlow

[email protected]

216-973-7865

Norton Cancer Institute, Louisville 4299276, Kentucky 6254925

Status

Recruiting

Address

Norton Cancer Institute

Louisville 4299276, Kentucky 6254925, 40202

Site Contact

Ben Orem

[email protected]

502-629-2500 #19471

Karmanos Cancer Institute, Detroit 4990729, Michigan 5001836

Status

Recruiting

Address

Karmanos Cancer Institute

Detroit 4990729, Michigan 5001836, 48201

Site Contact

Marie Ventimiglia

[email protected]

313-576-9271

Minneapolis 5037649, Minnesota 5037779

Status

Recruiting

Address

University of Minnesota Masonic Cancer Center

Minneapolis 5037649, Minnesota 5037779, 55455

Site Contact

Manar Al-Assi

[email protected]

857-399-9887

New York 5128581, New York 5128638

Status

Recruiting

Address

Columbia University Herbert Irving Comprehensive Cancer Center

New York 5128581, New York 5128638, 10032

Site Contact

Elizabeth Shelton, MPH

[email protected]

212-342-0248

Chapel Hill 4460162, North Carolina 4482348

Status

Recruiting

Address

University of North Carolina at Chapel Hill

Chapel Hill 4460162, North Carolina 4482348, 27599

Site Contact

UNC Immunotherapy Team

[email protected]

919-445-4208

The Cleveland Clinic, Cleveland 5150529, Ohio 5165418

Status

Recruiting

Address

The Cleveland Clinic

Cleveland 5150529, Ohio 5165418, 44195

Site Contact

Cancer Answer Line

[email protected]

216-444-7923

OU Health Stephenson Cancer Center, Oklahoma City 4544349, Oklahoma 4544379

Status

Recruiting

Address

OU Health Stephenson Cancer Center

Oklahoma City 4544349, Oklahoma 4544379, 73104

Site Contact

Cynthia Lowery

[email protected]

857-399-9887

Providence Cancer Institute Franz Clinic, Portland 5746545, Oregon 5744337

Status

Recruiting

Address

Providence Cancer Institute Franz Clinic

Portland 5746545, Oregon 5744337, 97213

Site Contact

Rom Leidner, MD

[email protected]

503-215-2614

Allegheny Hospitals Network, Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

Allegheny Hospitals Network

Pittsburgh 5206379, Pennsylvania 6254927, 15224

Site Contact

Shelly Evans

[email protected]

857-399-9887

University of Pittsburgh Medical Center, Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh 5206379, Pennsylvania 6254927, 15232

Site Contact

Barb Stadterman

[email protected]

857-399-9887

Sarah Cannon Research Institute, Nashville 4644585, Tennessee 4662168

Status

Recruiting

Address

Sarah Cannon Research Institute

Nashville 4644585, Tennessee 4662168, 37203

Site Contact

AskSarah AskSarah Help Line

[email protected]

844-482-4812

Baylor College of Medicine, Houston 4699066, Texas 4736286

Status

Recruiting

Address

Baylor College of Medicine

Houston 4699066, Texas 4736286, 77030

Site Contact

Luciana Narvaez

[email protected]

713-798-1694

Resources

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