NCT07638371
FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers
Recruiting
PHASE1Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~16 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:MSK-TCR5
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of related toxicities
Measured over 1 year
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Adam Schoenfeld, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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. :
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:
Exclusion
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:
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
Any exclusion criterion listed in Part A.
What this trial measures
- Number of related toxicities1 year
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.