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Aldesleukin / Endocrine Tumors / Ovarian Cancer · Phase 2 Trial
ClinicalTrials.gov · August 13, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective Phase 2 trial registration describing a personalized neoantigen-targeted TCR cell therapy approach for metastatic cancer, currently recruiting participants. No efficacy or safety results are posted in this registry record; the study design and conduct are described but outcomes remain pending.
Phase 2, Interventional, Non Randomized, Parallel, Open label, Treatment purpose. Endocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer, Gastrointestinal/Genitourinary Cancers, Neuroendocrine Tumors, Multiple Myeloma; age from 18 Years; to 72 Years. Intervention: 1/iTCR; 2/iTCR + Pembro. Compared with: Arm 1 (TCR therapy without checkpoint inhibitor) serves as internal comparator to Arm 2 (TCR therapy plus pembrolizumab); no external control arm is described in the registry record.. n = 285. 1 site: United States.
This is a prospective Phase 2 trial registration describing a personalized neoantigen-targeted TCR cell therapy approach for metastatic cancer, currently recruiting participants. No efficacy or safety results are posted in this registry record; the study design and conduct are described but outcomes remain pending.
This registry record reports only planned design and enrollment; no efficacy, safety, or outcome data are presented.
This trial is not yet interpretable clinically because no results are reported. Clinicians should monitor for eventual publication of efficacy and safety data, particularly regarding response rates and tolerability of dual cell therapy plus checkpoint inhibitor.
This is a Phase 2 interventional trial registration with no results yet posted; it describes planned enrollment and study design only, making it an early-stage assessment of a novel cell therapy approach.
As stated by the source record.
Quoted from the source exactly as published.
This trial is not yet interpretable clinically because no results are reported. Clinicians should monitor for eventual publication of efficacy and safety data, particularly regarding response rates and tolerability of dual cell therapy plus checkpoint inhibitor.
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 (NCT03412877). This is a study registration, not published results. Lead sponsor: National Cancer Institute (NCI). Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 285 participants (ESTIMATED). Conditions: Endocrine Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer, Gastrointestinal/Genitourinary Cancers, Neuroendocrine Tumors, Multiple Myeloma. Interventions: DRUG: Cyclophosphamide; DRUG: Fludarabine; DRUG: Aldesleukin; BIOLOGICAL: Individual Patient TCR-Transduced PBL; DRUG: Pembrolizumab (KEYTRUDA(R)). Primary outcome measures: Response rate , 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion. Brief summary: Background: A person s tumor is studied for mutations. When cells are found that can attack the mutation in a person s tumor, the genes from those cells are studied to find the parts that make the attack possible. White blood cells are then taken from the person s body, and the gene transfer occurs in a laboratory. A type of virus is used to transfer the genes that make those white blood cells able to attack the mutation in the tumor. The gene transfer therapy is the return of those white blood cells back to the person. Objective: To see if gene transfer therapy of white blood cells can shrink tumors. Eligibility: People with certain metastatic cancer for which standard treatments have not worked. Design: Participants may complete screening under another protocol. Screening includes: * Getting tumor cells from a previous procedure * Medical history * Physical exam * Scans * Blood, urine, heart, and lung tests The study has 8 stages: 1. Screening tests repeated over 1-2 weeks. Participants will have leukapheresis: Blood is removed by a needle in one arm. A machine removes white blood cells. The rest of the blood is returned by a needle in the other arm. 2. Care at home over approximately 12 weeks. 3. Stopping therapy for 4-6 weeks while their cells are changed in a lab. 4. Hospital stay approximately 3-4 weeks for treatment. An IV catheter will be placed in the chest to administer drugs. 5. Patients on Arm 2 of the study will receive the first dose of pembrolizumab while in the hospital. Three additional doses will be given after the cell infusion 3 weeks apart. 6. Receiving changed cells by catheter. Then getting a drug over 1-5 days to help the cells live longer. 7. Recover in the hospital for 1-2 weeks. Participants will get drugs and have blood and urine tests. 8. Participants will take an antibiotic and maybe an antiviral for at least 6 months after treatment. They will have repeat screening tests at visits every few months for the first year, every 6 months for the second year, then as determined. ...
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.