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NCT03190941 · ClinicalTrials.gov registry record · Phase 1
Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients
A Phase 1 study of Pancreatic Cancer and Gastric Cancer, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 110
- Enrollment target
- 1
- Study location
NCT03190941: Recruiting Phase 1 study of Pancreatic Cancer and Gastric Cancer, sponsored by National Cancer Institute (NCI).
NCT03190941 is a Phase 1 study of Pancreatic Cancer and Gastric Cancer that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 110 participants, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03190941, a Phase 1 study of Pancreatic Cancer and Gastric Cancer, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 110 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: A new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells. Objective: To see if anti-KRAS G12 V mTCR cells are safe and can shrink tumors. Eligibility: Adults at least 18 years old with cancer that has the KRAS G12V molecule on the surface of tumors. Design: In another protocol, participants will: Be screened Have cells harvested and grown Have leukapheresis In this protocol, participants will have the procedures below. Participants will be admitted to the hospital. Over 5 days, participants will get 2 chemotherapy medicines as an infusion via catheter in the upper chest. A few days later, participants will get the anti-KRAS G12V mTCR cells via catheter. For up to 3 days, participants will get a drug to make the cells active. A day after getting the cells, participants will get a drug to increase their white blood cell count. This will be a shot or injection under the skin. Participants will recover in the hospital for 1-2 weeks. They will have lab and blood tests. Participants will take an antibiotic for at least 6 months. Participants will have visits every few months for 2 years, and then as determined by their doctor. Visits will be 1-2 days. They will include lab tests, imaging studies, and physical exam. Some visits may include leukapheresis or blood drawn. Participants will have blood collected over several years.
Primary Outcome
Percentage of patients who have a clinical response (PR+CR) to treatment (objective tumor regression)
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Aldesleukin
- BIOLOGICAL Anti-KRAS G12V mTCR PBL
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2017-09-21 |
| Est. Completion | 2028-06-29 |
| Phase | Phase 1 |
What NCT03190941 shows while recruiting
NCT03190941 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (72% lower).
The record links to 5 conditions, with Pancreatic Cancer appearing as the primary indexed condition, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03190941 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03190941 about?
NCT03190941 is a clinical study titled "Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients". Background: A new cancer therapy involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. This therapy is called gene transfer using anti-KRAS G12V mTCR cells. Objective: To see if anti-KRAS G12 V mTCR cells are saf...
What is the current status of trial NCT03190941?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 110 participants. The study started on 2017-09-21. Estimated completion is 2028-06-29.
What conditions does trial NCT03190941 study?
This clinical trial studies the following conditions: Pancreatic Cancer, Gastric Cancer, Colon Cancer, Rectal Cancer, Gastrointestinal Cancer.
What interventions are being tested in trial NCT03190941?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Aldesleukin (DRUG), Anti-KRAS G12V mTCR PBL (BIOLOGICAL).
Who is sponsoring clinical trial NCT03190941?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03190941 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03190941's enrollment target sits among peer trials
110 98th of 278 higher than 179 of 278 other Pancreatic Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pancreatic Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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