Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03190941
The ClinicalTrials.gov registry entry for NCT03190941 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 110 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 393-participant average among 278 other Pancreatic Cancer trials with a reported enrollment target (72% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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
Similar trials for Pancreatic Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
RECRUITING · Phase 1
-
A Phase IB Study to Determine the Safety and Tolerability of Canakinumab and Tislelizumab in Combination With Nab-Paclitaxel and Gemcitabine in the Neo-adjuvant Treatment of Patients With Pancreatic Cancer
RECRUITING · Phase 1
-
Ulixertinib/Palbociclib in Patients With Advanced Pancreatic and Other Solid Tumors
RECRUITING · Phase 1
-
EUS RFA for Treatment of Pancreatic Ductal Adenocarcinoma (PDAC)
RECRUITING · Phase 1
-
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
RECRUITING · Phase 1
-
64Cu-LNTH-1363S in Patients With Sarcoma or Gastrointestinal Tract Cancer
RECRUITING · Phase 1
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.