RecruitingPhase 1NCT06218914

Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors

Open-label, Phase 1, Multi-Center Master Protocol to Evaluate the Safety and Preliminary Anti-Tumor Activity of TCR-engineered T Cells Recognizing KRAS Mutations in Adult Subjects With Unresectable, Advanced, and/or Metastatic Solid Tumors


Sponsor

AstraZeneca

Enrollment

108 participants

Start Date

Mar 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Phase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 trial is testing a new personalized cell therapy (TCR-T cell therapy) that targets cancer cells carrying a specific mutation called KRAS G12D, which is common in several solid tumors. Researchers engineer the patient's own immune cells to recognize and attack cancer cells with this mutation. **You may be eligible if...** - You are 18 or older with advanced or metastatic solid tumor cancer (including lung, colorectal, pancreatic, endometrial, or other solid tumors) - Your tumor has a confirmed KRAS G12D mutation - You carry specific immune cell types (HLA-C*08:02 or HLA-A*11:01/A*11:02) - You have received at least one prior standard treatment - You have measurable disease and a good performance status (ECOG 0–1) **You may NOT be eligible if...** - You do not have the required KRAS G12D mutation or the specific immune cell types - You have had prior gene therapy, CAR-T therapy, or organ/stem cell transplant - You have active brain metastases or a history of stroke within the past year - You have significant heart disease or heart failure - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALNT-112: Autologous, engineered T Cells targeting KRAS G12D

NT-112 targets KRAS G12D in the context of HLA-C\*08:02

BIOLOGICALAZD0240: Autologous, engineered T Cells targeting KRAS G12D

AZD0240 targets KRAS G12D in the context of HLA-A\*11:01 or HLA-A\*11:02


Locations(18)

Research Site

Duarte, California, United States

Research Site

Los Angeles, California, United States

Research Site

Newport Beach, California, United States

Research Site

Jacksonville, Florida, United States

Research Site

Chicago, Illinois, United States

Research Site

Westwood, Kansas, United States

Research Site

Boston, Massachusetts, United States

Research Site

St Louis, Missouri, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Portland, Oregon, United States

Research Site

Philadelphia, Pennsylvania, United States

Research Site

Pittsburgh, Pennsylvania, United States

Research Site

Nashville, Tennessee, United States

Research Site

Dallas, Texas, United States

Research Site

Galveston, Texas, United States

Research Site

Houston, Texas, United States

Research Site

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06218914


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