Solid TumorPhase 1NCT07638371
FORTRAS: A Study of MSK-TCR5 in People With Solid Tumor Cancers
A Phase 1 study testing MSK-TCR5 in people with Solid Tumor and Solid Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Solid Carcinoma, Advanced Solid Tumor
- What is being tested?
- MSK-TCR5
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesUnited States
- Study dates
- 9 Jun 2026to 9 Jun 2030
- 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
- Part A: Prior to cell collection all of the following inclusion criteria must be met:
- 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. :
- Part B: Prior to treatment with MSK-TCR5 all of the following inclusion criteria must be met:
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- 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
- CrCl ≥50 mL/min by Cockcroft-Gualt equation
Who cannot join
- Part A: Participant Exclusion Criteria prior to cell collection
- 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.
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- Uncontrolled significant intercurrent or recent illness including, but not limited to the following conditions:
- 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
- Part B: Participant Exclusion Criteria prior to MSK-TCR5 infusion
- Any exclusion criterion listed in Part A.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Adam Schoenfeld, MD, 646-608-4042
- Recruiting
Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Adam Schoenfeld, MD, 646-608-4042
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Adam Schoenfeld, MD, 646-608-4042
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Adam Schoenfeld, MD, 646-608-4042
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Adam Schoenfeld, MD, 646-608-4042
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Lauren Schaff, MD, 212-610-0485
- Recruiting
Memorial Sloan Kettering Cancer Center @ Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Adam Schoenfeld, MD, 646-608-4042
About this study
Official title: 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
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.
- Conditions
- Solid Tumor, Solid Carcinoma, Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor
- Being tested
- MSK-TCR5
- Keywords
- Solid Tumor, Solid Carcinoma, Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Memorial Sloan Kettering Cancer Center, 26-083, MSK05:A11RASD TCR-T cells
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSK-TCR5Biological
Also called Modified T-calls
MSK-TCR5 cells created in participant-derived T cells and autologously reinfused into eligible participants following lymphodepleting chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: 1.0 x 10^10 Cell Dose (cell number) | Experimental | Not described Receives: Biological: MSK-TCR5 |
| Dose Level 2: 3.0 x 10^10 Cell Dose (cell number) | Experimental | Not described Receives: Biological: MSK-TCR5 |
| Dose Level 3: 0.3 to 1.0 x 10^11 Cell Dose (cell number) | Experimental | Not described Receives: Biological: MSK-TCR5 |
| Dose Level -1: 3.0. x 10^9 Cell Dose (cell number) | Experimental | Not described Receives: Biological: MSK-TCR5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start9 Jun 2026
- Primary completion9 Jun 2030 (estimated)
- Study completion9 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Sequential
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adam Schoenfeld, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638371
- Sponsor's protocol ID
- 26-083
- Status last verified
- Oct 2026
- First submitted
- 5 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07638371
- Acronym / sponsor ID
- 26-083
- Conditions
- Solid Tumor, Solid Carcinoma, Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor
- Keywords
- Solid Tumor, Solid Carcinoma, Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor, Memorial Sloan Kettering Cancer Center, 26-083, MSK05:A11RASD TCR-T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 9 Jun 2030 (estimated)
- Study completion
- 9 Jun 2030 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: 1.0 x 10^10 Cell Dose (cell number) | Experimental | Biological: MSK-TCR5 |
| Dose Level 2: 3.0 x 10^10 Cell Dose (cell number) | Experimental | Biological: MSK-TCR5 |
| Dose Level 3: 0.3 to 1.0 x 10^11 Cell Dose (cell number) | Experimental | Biological: MSK-TCR5 |
| Dose Level -1: 3.0. x 10^9 Cell Dose (cell number) | Experimental | Biological: MSK-TCR5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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. :
- Part B: Prior to treatment with MSK-TCR5 all of the following inclusion criteria must be met:
Key exclusion criteria (18 listed)
- Part A: Participant Exclusion Criteria prior to cell collection
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSK-TCR5Also: Modified T-callsMSK-TCR5 cells created in participant-derived T cells and autologously reinfused into eligible participants following lymphodepleting chemotherapy | Biological | Dose Level -1: 3.0. x 10^9 Cell Dose (cell number), Dose Level 1: 1.0 x 10^10 Cell Dose (cell number), Dose Level 2: 3.0 x 10^10 Cell Dose (cell number), Dose Level 3: 0.3 to 1.0 x 10^11 Cell Dose (cell number) |
Primary outcome
Number of related toxicities
Time frame: 1 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Schoenfeld, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSK-TCR5 in people with Solid Tumor and Solid Carcinoma, run by Memorial Sloan Kettering Cancer Center at 7 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 15 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Contact Adam Schoenfeld, MD (646-608-4042, schoenfa@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of related toxicities (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.