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
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
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
- Wang, Qiong J., Zhiya Yu, Kayla Griffith, Ken-ichi Hanada, Nicholas P. Restifo, and James C. Yang. 2016. “Identification of T-cell Receptors Targeting Kras-mutated Human Tumors”. Cancer Immunology Research. American Association for Cancer Research (AACR). doi:10.1158/2326-6066.cir-15-0188.
- Abrams, Scott I., Samir N. Khleif, Elke S. Bergmann-Leitner, Judith A. Kantor, Yoomie Chung, J.Michael Hamilton, and Jeffrey Schlom. 1997. “Generation of Stable Cd4+and CD8+T Cell Lines from Patients Immunized Withrasoncogene-derived Peptides Reflecting Codon 12 Mutations”. Cellular Immunology. Elsevier BV. doi:10.1006/cimm.1997.1224.
- Davis, Jeremy L., Marc R. Theoret, Zhili Zheng, Cor H.J. Lamers, Steven A. Rosenberg, and Richard A. Morgan. 2010. “Development of Human Anti-murine T-cell Receptor Antibodies in Both Responding and Nonresponding Patients Enrolled in TCR Gene Therapy Trials”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-10-1280.
- Abrams SI, Khleif SN, Bergmann-Leitner ES, Kantor JA, Chung Y, Hamilton JM, Schlom J. Generation of stable CD4+ and CD8+ T cell lines from patients immunized with ras oncogene-derived peptides reflecting codon 12 mutations. Cell Immunol. 1997 Dec 15;182(2):137-51. doi: 10.1006/cimm.1997.1224.
- 2017. "Administering Peripheral Blood Lymphocytes Transduced With a Murine T-Cell Receptor Recognizing the G12V Variant of Mutated RAS in HLA-A*11:01 Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03190941.
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Conditions
Cancer Related
Treatments