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CAR T-cell Therapy

Gene Transfer Therapy for Gastrointestinal Cancer

Phase 1 & 2
Recruiting
Led By James C Yang, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with measurable, metastatic, or unresectable malignancy expressing G12V mutated KRAS or G12V mutated NRAS and HRAS
Patients must be HLA-A*11:01 positive as confirmed by the NIH Department of Transfusion Medicine
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion
Awards & highlights

Study Summary

This trial is testing a new cancer therapy that involves taking white blood cells from a person, growing them in the lab, genetically modifying them, then giving them back to the person. The therapy is called gene transfer using anti-KRAS G12V mTCR cells.

Who is the study for?
Adults aged 18-70 with certain types of cancer (like gastrointestinal, colon, colorectal, pancreatic, or stomach) that have a specific molecule called KRAS G12V. They must have tried standard treatments or be unable to receive them and agree to use birth control. People can't join if they're pregnant/breastfeeding, on steroids, have immune deficiencies or severe infections, heart/pulmonary issues related to the trial drugs.Check my eligibility
What is being tested?
The study tests a new therapy where patients' white blood cells are modified in the lab to target cancer cells with KRAS G12V mutation. It involves chemotherapy followed by cell infusion and supportive medications in hospital over several weeks with follow-up visits for up to two years.See study design
What are the potential side effects?
Possible side effects include reactions from the genetically modified cells or chemotherapy drugs like fatigue, nausea, infection risk increase; organ inflammation; allergic reactions; changes in blood counts; liver enzyme elevations. Specific risks will depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer is advanced, cannot be surgically removed, and has a specific genetic mutation.
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I am HLA-A*11:01 positive as confirmed by testing.
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My advanced cancer did not respond to or has returned after standard treatment.
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I am between 18 and 72 years old.
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I have up to 3 small brain tumors that don't cause symptoms.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks and 12 weeks following administration of the cell product, then every 3 months x3, then every 6 months x 2 years, then per pi discretion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency and severity of treatment-related adverse events
Response rate

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2/Phase IIExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + MTD of anti-KRAS G12V mTCR PBL + high-dose aldesleukin
Group II: 1/Phase IExperimental Treatment4 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + escalating doses of anti-KRAS G12V mTCR PBL + high-dose aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
Aldesleukin
2012
Completed Phase 4
~1620

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,285 Total Patients Enrolled
James C Yang, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
422 Total Patients Enrolled

Media Library

Anti-KRAS G12V mTCR PBL (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03190941 — Phase 1 & 2
Gastrointestinal Cancer Research Study Groups: 1/Phase I, 2/Phase II
Gastrointestinal Cancer Clinical Trial 2023: Anti-KRAS G12V mTCR PBL Highlights & Side Effects. Trial Name: NCT03190941 — Phase 1 & 2
Anti-KRAS G12V mTCR PBL (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03190941 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions has Anti-KRAS G12V mTCR PBL been found to alleviate?

"Multiple sclerosis, Leukemia, Myelocytic Acute, and Retinoblastoma have all been identified as potential targets for Anti-KRAS G12V mTCR PBL."

Answered by AI

Are there documented precedents of Anti-KRAS G12V mTCR PBL clinical trials?

"At present, there are 163 Phase 3 trials and 913 overall studies on Anti-KRAS G12V mTCR PBL. These experiments have been set up in a total of 28673 different areas with the majority being conducted in Philadelphia, Pennsylvania."

Answered by AI

Are the parameters for participant eligibility restricted to those under 25 years of age?

"Potential participants for this trial must be aged 18 and above, but not yet 70."

Answered by AI

Is this experiment actively seeking volunteers?

"As per the data on clinicaltrials.gov, this investigation is currently recruiting volunteers. It was initially posted in September 2017 and most recently edited in October 2022."

Answered by AI

Do I satisfy the criteria to partake in this research?

"This medical study is looking for 110 individuals, aged 18 to 70 years old, who have been diagnosed with malignant neoplasm of the colon. To be eligible, participants must additionally comply with a range of conditions that include: being HLA-A*11:01 positive as verified by an NIH Transfusion Medicine lab; confirmation of their cancer diagnosis by NCI Laboratory Pathology and having measurable metastatic unresectable tumours expressing G12V mutated KRAS (as established through RT-PCR on tumor tissue); having had at least two rounds of systemic chemotherapy containing 5FU, leucovorin plus bev"

Answered by AI

What is the headcount of participants in this experiment?

"Affirmative. Clinicaltrials.gov reports that this clinical trial, which was first shared on September 21st 2017, is still actively seeking participants. 110 individuals are necessary to be enrolled from 1 hospital site."

Answered by AI
Recent research and studies
~37 spots leftby Jun 2027