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Pancreatic Ductal AdenocarcinomaPhase 1/2NCT06105021

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

A Phase 1/2 study testing AFNT-211 in people with Pancreatic Ductal Adenocarcinoma and Non-Small Cell Lung Cancer, run by Affini-T Therapeutics, Inc. at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AFNT-211
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
10 sitesUnited States
Study dates
6 Mar 2024to Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed KRAS G12V mutational status and HLA-A*11:01 allele
  • Histologically confirmed advanced or metastatic, unresectable solid tumor
  • Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy.
  • Measurable disease per RECIST v1.1.
  • ECOG performance status 0-1
  • Adequate organ and bone marrow function

Who cannot join

  • Any systemic cytotoxic chemotherapy, investigational agents, or any anti-tumor drug from a previous treatment regimen or clinical study (including small molecules and I/O compounds) within 5 half-lives or 14 days of Screening, whichever is shorter.
  • Any prior gene therapy utilizing an integrating vector
  • Previous allogeneic stem cell transplantation or prior organ transplantation
  • History of treated primary immunodeficiency, autoimmune, or inflammatory disease including inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, myasthenia gravis, or Grave's disease
  • Primary brain tumor
  • Untreated central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.
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  • Uncontrolled active bacterial, viral, fungal, or mycobacterial infection
  • Pregnant or lactating subjects
  • Surgery or catheter-based interventions
  • Previously identified allergy, hypersensitivity, or known contraindication to cyclophosphamide, fludarabine, or any other agent associated with lymphodepleting chemotherapy (LDC) or AFNT-211 product
  • Uncontrolled significant intercurrent or recent illness
  • Diagnosis of another malignancy within 2 years prior to screening.
  • Seropositive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb)
  • Seropositive for hepatitis C antibody.
  • Known human immunodeficiency virus (HIV) infection

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • USC Norris Comprehensive

    Los Angeles, California, 90033

  • University of California Los Angeles Department of Medicine

    Los Angeles, California, 90095

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109

Other trials in United States

About this study

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.

Read the detailed description

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.

Being tested
AFNT-211
Keywords
PDAC, NSCLC, CRC, human leukocyte antigen-A, Kirsten rat sarcoma, HLA-A*11:01, KRAS, G12V, LDC, Lymphodepleting chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Syndactyly, Type I

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AFNT-211Drug

    Engineered TCR T-Cell

Study groups in NCT06105021
Study groupRoleWhat they receive
Dose EscalationExperimentalSubjects 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 biological dose and recommended phase 2 dose will be determined.
Receives: Drug: AFNT-211
Dose Expansion: PDACExperimental20 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.
Receives: Drug: AFNT-211
Dose Expansion: CRCExperimental20 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.
Receives: Drug: AFNT-211
Dose Expansion: NSCLCExperimental20 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.
Receives: Drug: AFNT-211
Dose Expansion: Adv Solid TumorsExperimental20 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.
Receives: Drug: AFNT-211

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 60 months

  2. 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

    Measured: 60 months

  3. Incidence of Treatment Emergent Adverse Events

    The incidence of TEAEs will be used to determine safety and tolerability of AFNT-211

    Measured: 60 months

  4. Incidence of Serious Adverse Events

    The incidence of SAEs will be used to determine safety and tolerability of AFNT-211

    Measured: 60 months

  5. Incidence of Dose Limiting Toxicities

    The incidence of DLTs during Dose Escalation will be used to determine safety and tolerability of AFNT-211

    Measured: 18 months

Secondary outcomes (6)

  1. 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

    Measured: 60 months

  2. 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.

    Measured: 60 months

  3. Progression-free Survival (PFS)

    From enrollment to first documentation of disease progression or death of any cause, whichever occurs first.

    Measured: 60 months

  4. Time to Response (TTR)

    Time from first AFNT-211 infusion to first documentation of PR or better.

    Measured: 60 months

  5. Clinical Benefit Rate (CBR)

    Percentage of subjects who have achieved PR or CR, or had stable disease (SD) for 6 months or more.

    Measured: 60 months

  6. Overall Survival (OS)

    From time of enrollment to death from any cause

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Oct 2023
  2. Study start6 Mar 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
This is a Phase I, FIH, multicenter, open-label study of AFNT-211 consisting of a dose escalation part and a dose expansion part. During dose escalation the optimal biological dose (OBD) will be determined as well as the recommended phase 2 dose (RP2D). Additional subjects will enroll in expansion cohorts treated at OBD/RP2D found in escalation.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06105021
Sponsor's protocol ID
AFNT211-22-101
Status last verified
Jul 2025
First submitted
9 Oct 2023
Last updated
30 Jul 2025
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AFNT-211 in people with Pancreatic Ductal Adenocarcinoma and Non-Small Cell Lung Cancer, run by Affini-T Therapeutics, Inc. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the Optimal Biological Dose (OBD) (time frame: 60 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06105021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.

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