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NCT06253520 · ClinicalTrials.gov registry record · Phase 1
Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer
A Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 210
- Enrollment target
- 1
- Study location
NCT06253520 is a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 210 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06253520, a Phase 1 study of Breast Cancer and Non-Small Cell Lung Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 210 participants
- Enrollment target
- 1
- Study location
Study 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. ...
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- BIOLOGICAL KRAS TCR-Transduced PBL
- BIOLOGICAL GRT-C903/GRT-R904
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 210 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2033-06-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06253520
The ClinicalTrials.gov registry entry for NCT06253520 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 210 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (93% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06253520 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06253520 about?
NCT06253520 is a clinical study titled "Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer". 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 speci...
What is the current status of trial NCT06253520?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 210 participants. The study started on 2024-05-16. Estimated completion is 2033-06-15.
What conditions does trial NCT06253520 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small Cell Lung Cancer, Colorectal Cancer, Ovarian Cancer, Gastrointestinal Cancer.
What interventions are being tested in trial NCT06253520?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), KRAS TCR-Transduced PBL (BIOLOGICAL), GRT-C903/GRT-R904 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06253520?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06253520 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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