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2024-03-06
2025-12
2029-12
100
NCT06105021
Affini-T Therapeutics, Inc.
Affini-T Therapeutics, Inc.
INTERVENTIONAL
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 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.
AFNT-211 is a cellular therapy consisting of autologous CD4+ and CD8+ T cells engineered to express a human leukocyte antigen-A (HLA-A)*11:01-restricted Kirsten rat sarcoma (KRAS) G12V-specific transgenic T cell receptor (TCR), the wildtype CD8α/β coreceptor, and a FAS-41BB switch receptor. AFNT-211 is being developed by Affini-T Therapeutics, Inc. (hereafter, "the Sponsor") for the treatment of patients with malignant solid tumors. The primary purpose of this study is to assess the safety and tolerability of AFNT-211 in subjects who are HLA-A*11:01 positive with advanced or metastatic cancers that harbor a KRAS G12V mutation, as well as determine the optimal biological dose (OBD) and recommended Phase II dose (RP2D) of AFNT-211 in this population. This study will also evaluate the preliminary anti-tumor activity of AFNT-211.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2023-10-09 | N/A | 2025-07-28 |
2023-10-23 | N/A | 2025-07-30 |
2023-10-27 | N/A | 2025-07 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Sequential
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Dose Escalation Subjects will be given a one-time infusion of AFNT-211 starting at dose level 1 and monitored for 28 days (DLT period). Each cohort will enroll 2-4 subjects at different dose levels for a total of 20 subjects in the escalation portion. The optimal biologi | DRUG: AFNT-211
|
| EXPERIMENTAL: Dose Expansion: PDAC 20 subjects with pancreatic ductal adenocarcinoma will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. | DRUG: AFNT-211
|
| EXPERIMENTAL: Dose Expansion: CRC 20 subjects with colorectal carcinoma will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. | DRUG: AFNT-211
|
| EXPERIMENTAL: Dose Expansion: NSCLC 20 subjects with non-small cell cancer will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. | DRUG: AFNT-211
|
| EXPERIMENTAL: Dose Expansion: Adv Solid Tumors 20 subjects with solid tumors will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. | DRUG: AFNT-211
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Determine the Optimal Biological Dose (OBD) | Quantify the desirability of a dose in terms of toxicity-efficacy tradeoff during the dose escalation portion of the study | 60 months |
| Determine the Recommended Phase 2 Dose | This will be selected based on Bayesian optimal interval Phase I/II (BOIN12) design recommendation and the totality of benefit-risk evidence during dose escalation | 60 months |
| Incidence of Treatment Emergent Adverse Events | The incidence of TEAEs will be used to determine safety and tolerability of AFNT-211 | 60 months |
| Incidence of Serious Adverse Events | The incidence of SAEs will be used to determine safety and tolerability of AFNT-211 | 60 months |
| Incidence of Dose Limiting Toxicities | The incidence of DLTs during Dose Escalation will be used to determine safety and tolerability of AFNT-211 | 18 months |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | Percentage of subjects who achieved partial response (PR) or complete response (CR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | 60 months |
| Duration of Response (DOR) | Time from first documentation of response of PR or better to first documentation of disease progression or death from any cause, whichever occurs first. | 60 months |
| Progression-free Survival (PFS) | From enrollment to first documentation of disease progression or death of any cause, whichever occurs first. | 60 months |
| Time to Response (TTR) | Time from first AFNT-211 infusion to first documentation of PR or better. | 60 months |
| Clinical Benefit Rate (CBR) | Percentage of subjects who have achieved PR or CR, or had stable disease (SD) for 6 months or more. | 60 months |
| Overall Survival (OS) | From time of enrollment to death from any cause | 60 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
