Anti-KRAS G12V mTCR PBL for Gastrointestinal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gastrointestinal Cancer+4 MoreAnti-KRAS G12V mTCR PBL - Biological
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Gastrointestinal Cancer
  • Colon Cancer
  • Stomach Cancer
  • Pancreatic Cancer
  • Colorectal Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: 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

Year 2
Response rate
From time of cell infusion to two weeks after cell infusion
Frequency and severity of treatment-related adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

1/Phase I
1 of 2
2/Phase II
1 of 2

Experimental Treatment

110 Total Participants · 2 Treatment Groups

Primary Treatment: Anti-KRAS G12V mTCR PBL · No Placebo Group · Phase 1 & 2

1/Phase IExperimental Group · 5 Interventions: Aldesleukin, Cyclophosphamide, Fludarabine, Anti-KRAS G12V mTCR PBL, High-dose Aldesleukin · Intervention Types: Drug, Drug, Drug, Biological, Drug
2/Phase IIExperimental Group · 5 Interventions: Aldesleukin, Cyclophosphamide, Fludarabine, Anti-KRAS G12V mTCR PBL, High-dose Aldesleukin · Intervention Types: Drug, Drug, Drug, Biological, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Cyclophosphamide
FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,087 Previous Clinical Trials
41,141,596 Total Patients Enrolled
James C Yang, M.D.Principal InvestigatorNational Cancer Institute (NCI)
6 Previous Clinical Trials
422 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must be HLA-A*11:01 positive as confirmed by the NIH Department of Transfusion Medicine.
You have a confirmed diagnosis of cancer.
You have had an approved first line chemotherapy regimen for ovarian cancer or prostate cancer.
You have a diagnosis of Hodgkin's lymphoma and have received standard treatment.
You have surgically resected brain metastases.
References