Custom immune cells take on multiple cancers in early trial
NCT ID NCT05973487
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests a new treatment called T-Plex for people with advanced solid tumors (like head and neck, cervical, or melanoma) that haven't responded to standard therapies. The treatment uses a patient's own immune cells, which are modified in a lab to recognize and attack cancer cells. The main goals are to check if it's safe and to find the best dose.
Why investors are watching
TScan Therapeutics is testing T-Plex, a personalized cell therapy that engineers a patient's own T cells to attack multiple cancer antigens, in a large phase 1 basket trial across many solid tumor types. For a micro-cap company with no approved products, this trial is the main source of its value, and the safety and early efficacy data will show whether the approach works in a broad patient group.
If it works: If the trial shows the therapy is safe and shrinks tumors in some patients, TScan could advance to later-stage studies and attract partnership interest from larger drug companies. That would validate its platform and give the company a path toward a marketable product.
If it fails: Phase 1 trials often fail to show enough benefit, and a poor safety or efficacy result could set the program back years and hurt the company's ability to raise money. Delays in enrolling 840 patients across many sites could also drain its limited cash reserves.
AI-written from the trial record. Speculative, and not investment advice.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 840 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Allegheny Hospitals Network
Pittsburgh, Pennsylvania, 15224, United States
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Baylor College of Medicine
Houston, Texas, 77030, United States
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Columbia University Herbert Irving Comprehensive Cancer Center
New York, New York, 10032, United States
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HonorHealth Research and Innovation Institute
Scottsdale, Arizona, 85258, United States
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Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
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Memorial Healthcare System
Hollywood, Florida, 33021, United States
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Norton Cancer Institute
Louisville, Kentucky, 40202, United States
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OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
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Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
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Orlando Health
Orlando, Florida, 32806, United States
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Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213, United States
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Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
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The Cleveland Clinic
Cleveland, Ohio, 44195, United States
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University of California San Diego
San Diego, California, 92037, United States
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University of Chicago
Chicago, Illinois, 60637, United States
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University of Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
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University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232, United States
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University of South Florida
Tampa, Florida, 33606, United States
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Yale Cancer Center
New Haven, Connecticut, 06510, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can MRI and computer models predict how well cancer drugs reach tumors?
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