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Aldesleukin / Metastatic Solid Cancers / Colorectal Cancer · Phase 1 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 trial registration (NCT06253520) of autologous KRAS-targeted T-cell receptor-engineered lymphocytes combined with a therapeutic vaccine in adults with metastatic solid tumors. The registry record describes the protocol and planned outcome measures but reports no efficacy or safety results; the study is currently active but not recruiting.
Phase 1, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Metastatic Solid Cancers, Colorectal Cancer, Breast Cancer, Non-Small Cell Lung Cancer, Gastrointestinal Cancer, Ovarian Cancer, Genitourinary Cancer; age from 18 Years; to 72 Years. Intervention: 1/ KRAS TCR + vaccine. n = 210. 1 site: United States.
This is a Phase 1 trial registration (NCT06253520) of autologous KRAS-targeted T-cell receptor-engineered lymphocytes combined with a therapeutic vaccine in adults with metastatic solid tumors. The registry record describes the protocol and planned outcome measures but reports no efficacy or safety results; the study is currently active but not recruiting.
This is a registry record with no results posted; no efficacy, response rate, or safety data are available. Phase 1 design limits ability to assess clinical benefit; primary goal is feasibility and safety in a heterogeneous population across seven cancer types.
This trial is not yet reporting results; clinicians should not infer efficacy or safety data from this registry entry. When results become available, Phase 1 data will primarily inform safety, tolerability, and immunological activity rather than clinical benefit, which would require later-phase studies.
Phase 1 trial of a novel combination of KRAS-targeted TCR-engineered T-cells with therapeutic vaccine in metastatic solid cancers; registry record with no results posted; early-stage feasibility and safety assessment.
As stated by the source record.
Quoted from the source exactly as published.
This trial is not yet reporting results; clinicians should not infer efficacy or safety data from this registry entry. When results become available, Phase 1 data will primarily inform safety, tolerability, and immunological activity rather than clinical benefit, which would require later-phase studies.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06253520). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 210 participants (ESTIMATED). Conditions: Metastatic Solid Cancers, Colorectal Cancer, Breast Cancer, Non-Small Cell Lung Cancer, Gastrointestinal Cancer, Ovarian Cancer, Genitourinary Cancer. Interventions: DRUG: Aldesleukin; DRUG: Fludarabine; DRUG: Cyclophosphamide; BIOLOGICAL: KRAS TCR-Transduced PBL; BIOLOGICAL: GRT-C903/GRT-R904. Primary outcome measures: Complete response (CR) and/ or partial response (PR) , Response assessed at 4, 8, 12 and 20 weeks post-cell infusion, every 3 months x3, every 6 months x 2 years; Safety , All adverse Events (AE) per CTCAE v5.0, by type and grade of toxicity, from first dose through 4 weeks after the last treatment. Brief summary: Background: Many cancer cells produce substances called antigens that are unique to each cancer. These antigens stimulate the body s immune responses. One approach to treating these cancers is to take disease-fighting white blood cells from a person, change those cells so they will target the specific proteins (called antigens) from the cancer cells, and return them to that person s blood. The use of the white blood cells in this manner is one form of gene therapy. A vaccine may help these modified white cells work better. Objective: To test a cancer treatment that uses a person s own modified white blood cells along with a vaccine that targets a specific protein. Eligibility: Adults aged 18 to 72 years with certain solid tumors that have spread after treatment. Design: Participants will undergo leukapheresis: Blood is removed from the body through a tube attached to a needle inserted into a vein. The blood passes through a machine that separates out the white blood cells. The remaining blood is returned to the body through a second needle. Participants will stay in the hospital for 3 or 4 weeks. They will take chemotherapy drugs for 1 week to prepare for the treatment. Then their modified white cells will be infused through a needle in the arm. They will take other drugs to prevent infections after the infusion. The vaccine is injected into a muscle; participants will receive their first dose of the vaccine on the same day as their cell infusion. Participants will have follow-up visits 4, 8, and 12 weeks after the cell infusions. They will receive 2 or 3 additional doses of the boost vaccine during these visits. Follow-up will continue for 5 years, but participants will need to stay in touch with the gene therapy team for 15 years. ...
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