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NCT06105021 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor

A Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Affini-T Therapeutics.

Active
Registry status
Phase 1
Development phase
100
Enrollment target
10
Study locations

NCT06105021: Active Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, sponsored by Affini-T Therapeutics.

NCT06105021 is a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer that is active but no longer recruiting, run by Affini-T Therapeutics. The registered enrollment target is 100 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06105021, a Phase 1 study of Non-Small Cell Lung Cancer and Colorectal Cancer, is active but no longer recruiting, sponsored by Affini-T Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
100 participants
Enrollment target
10
Study locations

Study Summary

This study is open to adult patients with solid tumors who have a KRAS G12V mutation. This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and other cancers. The study is for patients whose cancer has spread through the body and for whom previous treatments were not successful or treatment does not exist. Patients must also be positive for HLA-A\*11:01. The purpose of this study is to find the best dose of AFNT-211 that is safe and can shrink tumors in patients. AFNT-211 is an investigational therapy and this is the first time that AFNT-211 is being administered to patients. AFNT-211 is an autologous T cell product which means that it is made from a patient's own T cells. These cells are engineered and grown to recognize the KRAS G12V protein on the cell surface of cancer cells. AFNT-211 is infused into patients after a short course of lymphodepleting chemotherapy. Patients will frequently visit the study site. The doctors there will regularly check the size of the cancer and the patient's health. They will also take note of any unwanted effects. Patients may continue in this study for as long as they benefit from the treatment.

Primary Outcome

Quantify the desirability of a dose in terms of toxicity-efficacy tradeoff during the dose escalation portion of the study

Conditions Studied

Non-Small Cell Lung Cancer Colorectal Cancer Solid Tumor Pancreatic Ductal Adenocarcinoma Kras G12V

Interventions

  • DRUG AFNT-211

Study Locations (10)

California

  • USC Norris Comprehensive - Los Angeles
  • University of California Los Angeles Department of Medicine - Los Angeles

New York

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York
  • Memorial Sloan Kettering Cancer Center - New York

Connecticut

  • Yale New Haven Hospital - New Haven

Oregon

  • Providence Cancer Institute Franz Clinic - Portland

Tennessee

  • Sarah Cannon Research Institute - Nashville

Texas

  • MD Anderson Cancer Center - Houston

Washington

  • Fred Hutchinson Cancer Center - Seattle

Wisconsin

  • University of Wisconsin Carbone Cancer Center - Madison

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-03-06
Est. Completion 2029-12
Phase Phase 1
Affini-T Therapeutics

1 total trials

What the registry record for NCT06105021 still lists

NCT06105021 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (85% lower).

The record links to 5 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which AFNT-211 is the first listed.

NCT06105021 lists 10 locations in 8 states (California, New York, Connecticut).

Frequently Asked Questions

What is clinical trial NCT06105021 about?

NCT06105021 is a clinical study titled "Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor". This study is open to adult patients with solid tumors who have a KRAS G12V mutation. This mutation is often found in non-small cell lung cancer (NSCLC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC) and other cancers. The study is for patients whose cancer has spread through the ...

What is the current status of trial NCT06105021?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-03-06. Estimated completion is 2029-12.

What conditions does trial NCT06105021 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Colorectal Cancer, Solid Tumor, Pancreatic Ductal Adenocarcinoma, Kras G12V.

What interventions are being tested in trial NCT06105021?

The interventions under investigation include: AFNT-211 (DRUG).

Who is sponsoring clinical trial NCT06105021?

This trial is sponsored by Affini-T Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06105021 being conducted?

This trial has 10 study locations across California, Connecticut, New York, Oregon, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Non-Small Cell Lung 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.

Where NCT06105021's enrollment target sits among peer trials

100 233rd of 454 higher than 212 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06105021, the US trial registry maintained by the National Library of Medicine. NCT06105021 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.