A Study of MSK-TCR5 in People With Solid Tumor Cancers
FORTRAS: Phase I, Investigator Initiated, Dose-escalation Clinical Trial Evaluating a CD8 Alpha/Beta Armored RAS G12D/HLA-A*11:01-specific T-cell Receptor Therapy (MSK-TCR5) in Patients With Advanced Solid Tumors
1 other identifier
interventional
16
1 country
7
Brief Summary
The purpose of this study is to test the safety of MSK-TCR5 in participants with advance solid tumor cancer that has a KRAS, HRAS, or NRAS G12D mutation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2026
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2026
CompletedStudy Start
First participant enrolled
June 9, 2026
CompletedFirst Posted
Study publicly available on registry
June 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 9, 2030
June 11, 2026
June 1, 2026
4 years
June 5, 2026
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of related toxicities
Primary objective is to evaluate the safety of MSK-TCR5. Safety will be measured by the primary endpoint of the occurrence and nature of AEs per participants. AEs will be defined as DLTs and events according to the CTCAE v5.0, with the exception of CRS and ICANS, which will be according to the ASTCT consensus criteria.
1 year
Study Arms (4)
Dose Level 1: 1.0 x 10^10 Cell Dose (cell number)
EXPERIMENTALDose Level 2: 3.0 x 10^10 Cell Dose (cell number)
EXPERIMENTALDose Level 3: 0.3 to 1.0 x 10^11 Cell Dose (cell number)
EXPERIMENTALDose Level -1: 3.0. x 10^9 Cell Dose (cell number)
EXPERIMENTALInterventions
MSK-TCR5, created in participant-derived T cells and autologously reinfused into eligible participants following lymphodepleting chemotherapy
Eligibility Criteria
You may qualify if:
- Age ≥18 years.
- Histologically confirmed advanced or metastatic, unresectable solid tumor
- Positive for RAS G12D mutation and HLA-A\*11:01 allele
- Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease after at least 1 line of systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options. Subjects with stable disease (SD), or that present lack of clinical benefit from previous therapy (including treatment suspension due to toxicity) may be considered eligible for enrollment. :
- For CRC: Patients harboring genomic aberrations such as BRAFV600E mutations, HER2 amplifications, or VEGF expression for which FDA-approved targeted therapies are available must have received prior treatment with applicable FDA-approved targeted therapies, including multi-kinase inhibitors. Patients whose tumors have deficient mismatch repair (dMMR)/high microsatellite instability (MSI-H) must have received an immune checkpoint inhibitor prior to enrolling in this study.
- For NSCLC: Patients harboring genomic aberrations such as non-resistant EGFR mutations, ALK rearrangement, ROS rearrangement, and BRAF V600E mutation for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients with the appropriate PD-L1 expression score must have received treatment with an FDA-approved checkpoint inhibitor with or without chemotherapy consistent with the FDA-approved label.
- Any other solid tumors, including PDAC: Patients harboring genomic aberrations for which FDA-approved targeted therapies are available must have received prior treatment with the applicable FDA-approved targeted therapies. Patients whose tumors have dMMR/MSI-H must have received an immune checkpoint inhibitor prior to enrolling in this study.
- Measurable disease per RECIST version 1.1. Note: a previously irradiated or locoregionally treated lesion can be considered a target lesion if it progressed post-treatment.
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function based on the following laboratory values:
- ANC ≥1000/mm3 without granulocyte colony-stimulating factor support (filgrastim within 7 days or peg-filgrastim within 14 days of screening)
- Platelets ≥75,000/mm3 without transfusion within the preceding 7 days of screening.
- Hemoglobin ≥8.0 g/dL (≥80 g/L); blood transfusion permitted within 7 days of screening.
- AST, ALT, and ALP ≤ 3x ULN, or ≤ 5x ULN if liver or bone metastases present.
- Total bilirubin ≤ 1.5x ULN or ≤ 3x ULN in the presence of documented Gilbert's Syndrome
- +1 more criteria
You may not qualify if:
- Previous allogeneic stem cell transplantation or prior organ transplantation
- History of primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease that in the past year has required systemic treatment with corticosteroids \> 10mg/day of prednisone or equivalent doses of other corticosteroids or immunosuppressive drugs. Note: Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal/pituitary insufficiency is not considered a form of systemic treatment and allowed)
- Primary brain tumor
- Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression. Patients previously treated for CNS metastases that are radiographically and neurologically stable and off steroids for at least 2 weeks prior to enrollment are eligible.
- Surgery or catheter-based interventions such as transarterial chemoembolization or percutaneous coronary intervention within 2 weeks.
- Uncontrolled significant intercurrent or recent illness including, but not limited to the following conditions:
- a. Significant cardiovascular abnormalities as defined by any one of the following: uncontrolled congestive heart failure or hypertension, clinically significant hypotension, symptomatic coronary artery disease, or a documented ejection fraction (EF) of \< 50% as assessed by echocardiogram or multigated acquisition scan (MUGA).
- Uncontrolled active bacterial, viral, fungal, or mycobacterial infection not responding to antibiotics, antimycotics, or antifungal agents, as well as long-term oral treatment with any of these agents.
- Subject has had radiotherapy or systemic anti-cancer therapy within at least 2 weeks or 3 half-lives, whichever is shorter.
- Pregnant or lactating women; women of childbearing age, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception while receiving study treatment and for at least 12 months after all treatment is finished. Sexually active males, unless they are willing to use a condom during intercourse while receiving study treatment and for at least 12 months after all treatment is finished.
- Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with LDC or MSK-TCR5.
- Positive serologic test results for HIV.
- Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
- Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR
- Patient/parent/LAR unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748, United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645, United States
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725, United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Memorial Sloan Kettering Cancer Center @ Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Schoenfeld, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2026
First Posted
June 10, 2026
Study Start
June 9, 2026
Primary Completion (Estimated)
June 9, 2030
Study Completion (Estimated)
June 9, 2030
Last Updated
June 11, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
• Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.