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AzTrials

Head and Neck CancerPhase 1NCT05973487

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

A Phase 1 study testing TSC-204-A0201, TSC-204-C0702 and TSC-200-A0201 in people with Head and Neck Cancer and Cervical Cancer, run by TScan Therapeutics, Inc. at 21 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TSC-204-A0201, TSC-204-C0702 and TSC-200-A0201
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
21 sitesUnited States
Study dates
6 May 2024to 30 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must be at least 18 years.
  • 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.
  • 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.
  • 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
  • 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).
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
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  • Participants must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative.
  • At least 1 measurable lesion per modified Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Adequate bone marrow and organ function.

Who cannot join

  • Medical or psychological conditions that would make the participant unsuitable candidate for cell therapy at the discretion of the PI.
  • 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
  • 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.
  • History of stroke or transient ischemic attack (TIA) within 6 months of enrollment
  • Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7 days of enrollment.
  • History of severe hypersensitivity to fludarabine or cyclophosphamide or study product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or Plasma-Lyte.
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  • Untreated or symptomatic central nervous system (CNS) metastases or cytology proven carcinomatous meningitis.
  • 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.
  • Presence of fungal, bacterial, viral, or other infection requiring anti-microbials for management.
  • 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.
  • Participants who regularly require supplemental oxygen.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • University of Chicago

    Chicago, Illinois, 60637

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Norton Cancer Institute

    Louisville, Kentucky, 40202

  • University of Miami, Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • University of Minnesota Masonic Cancer Center

    Minneapolis, Minnesota, 55455

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale Cancer Center

    New Haven, Connecticut, 06510

  • Columbia University Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health

    Orlando, Florida, 32806

  • Allegheny Hospitals Network

    Pittsburgh, Pennsylvania, 15224

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • University of California San Diego

    San Diego, California, 92037

  • HonorHealth Research and Innovation Institute

    Scottsdale, Arizona, 85258

  • University of South Florida

    Tampa, Florida, 33606

Other trials in United States

About this study

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

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.

Read the detailed description

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).

Being tested
TSC-204-A0201, TSC-204-C0702, TSC-200-A0201, TSC-204-A0201 + TSC-204-C0702, TSC-204-A0201 + TSC-200-A0201
Keywords
HPV16 E7, MAGE-A1, TCR-T Therapy, Cell Therapy, Immunotherapy, TScan Therapeutics, TSCAN-002, TSCAN-003, PRAME, MAGE-C2, MAGE-A4
Medical subject headings
Head and Neck Neoplasms, Uterine Cervical Neoplasms, Melanoma, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TSC-204-A0201Biological

    Escalating doses of TSC-204-A0201 as a monotherapy

  • TSC-204-C0702Biological

    Escalating doses of TSC-204-C0702 as a monotherapy

  • TSC-200-A0201Biological

    Escalating doses of TSC-200-A0201 as a monotherapy

  • TSC-204-A0201 + TSC-204-C0702Biological

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

  • TSC-204-A0201 + TSC-200-A0201Biological

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

  • TSC-204-C0702 + TSC-200-A0201Biological

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

  • TSC-204-A0201 + TSC-203-A0201Biological

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

  • TSC-204-C0702 + TSC-203-A0201Biological

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

  • TSC-200-A0201 + TSC-203-A0201Biological

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

  • TSC-203-A0201Biological

    Escalating doses of TSC-203-A0201 as a monotherapy

  • TSC-204-A0101Biological

    Escalating doses of TSC-204-A0101 as a monotherapy

  • TSC-201-B0702Biological

    Escalating doses of TSC-201-B0702 as a monotherapy

  • TSC-204-A0201 + TSC-204-A0101Biological

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

  • TSC-204-A0201 + TSC-201-B0702Biological

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

  • TSC-204-C0702 + TSC-204-A0101Biological

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

  • TSC-204-C0702 + TSC-201-B0702Biological

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

  • TSC-200-A0201 + TSC-204-A0101Biological

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

  • TSC-200-A0201 + TSC-201-B0702Biological

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

  • TSC-203-A0201 + TSC-204-A0101Biological

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

  • TSC-203-A0201 + TSC-201-B0702Biological

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

  • TSC-202-A0201Biological

    Escalating doses of TSC-202-A0201 as a monotherapy

  • TSC-204-A0201 + TSC-202-A0201Biological

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

  • TSC-204-C0702 + TSC-202-A0201Biological

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

  • TSC-200-A0201 + TSC-202-A0201Biological

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

  • TSC-203-A0201 + TSC-202-A0201Biological

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

  • TSC-204-A0101 + TSC-202-A0201Biological

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

  • TSC-201-B0702 + TSC-202-A0201Biological

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

Study groups in NCT05973487
Study groupRoleWhat they receive
Monotherapy Cohort AExperimentalTSC-204-A0201
Receives: Biological: TSC-204-A0201
Monotherapy Cohort BExperimentalTSC-204-C0702
Receives: Biological: TSC-204-C0702
Monotherapy Cohort CExperimentalTSC-200-A0201
Receives: Biological: TSC-200-A0201
T-Plex Combination Cohort A + BExperimentalTSC-204-A0201 and TSC-204-C0702
Receives: Biological: TSC-204-A0201 + TSC-204-C0702
T-Plex Combination Cohort B + CExperimentalTSC-204-C0702 and TSC-200-A0201
Receives: Biological: TSC-204-A0201 + TSC-200-A0201
T-Plex Combination Cohort A + CExperimentalTSC-204-A0201 and TSC-200-A0201
Receives: Biological: TSC-204-C0702 + TSC-200-A0201
Monotherapy Cohort DExperimentalTSC-203-A0201
Receives: Biological: TSC-203-A0201
T-Plex Combination Cohort A + DExperimentalTSC-204-A0201 + TSC-203-A0201
Receives: Biological: TSC-204-A0201 + TSC-203-A0201
T-Plex Combination Cohort B + DExperimentalTSC-204-C0702 + TSC-203-A0201
Receives: Biological: TSC-204-C0702 + TSC-203-A0201
Monotherapy Cohort EExperimentalTSC-204-A0101
Receives: Biological: TSC-204-A0101
Monotherapy Cohort FExperimentalTSC-201-B0702
Receives: Biological: TSC-201-B0702
T-Plex Combination Cohort A + EExperimentalTSC-204-A0201 + TSC-204-A0101
Receives: Biological: TSC-204-A0201 + TSC-204-A0101
T-Plex Combination Cohort A + FExperimentalTSC-204-A0201 + TSC-201-B0702
Receives: Biological: TSC-204-A0201 + TSC-201-B0702
T-Plex Combination Cohort B + EExperimentalTSC-204-C0702 + TSC-204-A0101
Receives: Biological: TSC-204-C0702 + TSC-204-A0101
T-Plex Combination Cohort B + FExperimentalTSC-204-C0702 + TSC-201B0702
Receives: Biological: TSC-204-C0702 + TSC-201-B0702
T-Plex Combination Cohort C + DExperimentalTSC-200-A0201 + TSC-203-A0201
Receives: Biological: TSC-200-A0201 + TSC-203-A0201
T-Plex Combination Cohort C + EExperimentalTSC-200-A0201 + TSC-204-A0101
Receives: Biological: TSC-200-A0201 + TSC-204-A0101
T-Plex Combination Cohort C + FExperimentalTSC-200-A0201 + TSC-201B0702
Receives: Biological: TSC-200-A0201 + TSC-201-B0702
T-Plex Combination Cohort D + EExperimentalTSC-203-A0201 + TSC-204A0101
Receives: Biological: TSC-203-A0201 + TSC-204-A0101
T-Plex Combination Cohort D + FExperimentalTSC-203-A0201 + TSC-201B0702
Receives: Biological: TSC-203-A0201 + TSC-201-B0702
T-Plex Combination Cohort E + FExperimentalTSC-204-A0101 + TSC-201-B0702
Receives: Biological: TSC-204-A0101; Biological: TSC-201-B0702
Monotherapy Cohort GExperimentalTSC-202-A0201
Receives: Biological: TSC-202-A0201
T-Plex Combination Cohort A + GExperimentalTSC-204-A0201 + TSC-202-A0201
Receives: Biological: TSC-204-A0201 + TSC-202-A0201
T-Plex Combination Cohort B + GExperimentalTSC-204-C0702 + TSC-202-A0201
Receives: Biological: TSC-204-C0702 + TSC-202-A0201
T-Plex Combination Cohort C+ GExperimentalTSC-200-A0201 + TSC-202-A0201
Receives: Biological: TSC-200-A0201 + TSC-202-A0201
T-Plex Combination Cohort D + GExperimentalTSC-203-A0201 + TSC-202-A0201
Receives: Biological: TSC-203-A0201 + TSC-202-A0201
T-Plex Combination Cohort E + GExperimentalTSC-204-A0101 + TSC-202-A0201
Receives: Biological: TSC-204-A0101 + TSC-202-A0201
T-Plex Combination Cohort F + GExperimentalTSC-201-B0702 + TSC-202-A0201
Receives: Biological: TSC-201-B0702 + TSC-202-A0201

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety of monotherapy and T- Plex combination TCR-Ts

    Number of subjects with dose limiting toxicities (DLT)

    Measured: 28 days

  2. Determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

    Frequency and severity of DLTs, AEs and SAEs

    Measured: Up to 12 months

Secondary outcomes (2)

  1. Investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts

    Response Evaluation Criteria In Solid Tumors RECIST 1.1

    Measured: Up to 12 months

  2. Investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts

    Frequency and severity of DLTs, AEs and SAEs

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2023
  2. Study start6 May 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05973487
Sponsor's protocol ID
TSCAN-002
Status last verified
Nov 2025
First submitted
25 Jul 2023
Last updated
17 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TSC-204-A0201, TSC-204-C0702 and TSC-200-A0201 in people with Head and Neck Cancer and Cervical Cancer, run by TScan Therapeutics, Inc. at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety of monotherapy and T- Plex combination TCR-Ts (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05973487.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.

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