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CAR T-cell Therapy

Dose Escalation for Colorectal Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Affini-T Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Key

ECOG performance status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

Study Summary

This trial is for adult patients with certain types of cancer that have a specific genetic mutation. The purpose of the study is to determine the safe and effective dose of a new therapy called AFNT-211

Who is the study for?

Adults with advanced solid tumors and a specific KRAS G12V mutation can join this trial. They should have tried other treatments that didn't work or have no available treatment, be positive for HLA-A*11:01, and their cancer must be measurable by certain medical criteria. Good performance status and proper organ function are required.Check my eligibility

What is being tested?

The study tests AFNT-211, an experimental therapy made from the patient's own T cells engineered to target the KRAS G12V protein on cancer cells. It involves lymphodepleting chemotherapy followed by infusions of AFNT-211 to determine its safety and effectiveness in shrinking tumors.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune response, infusion-related symptoms, impact on blood counts due to chemotherapy, fatigue, possible infections due to lowered immunity, and other effects as the body adjusts to the engineered T cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is advanced, cannot be surgically removed, and has not responded to or I couldn't tolerate at least one treatment.

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My cancer has a specific KRAS mutation and I have a certain genetic marker.

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My cancer has worsened or I couldn't tolerate my previous cancer treatment.

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My cancer is advanced, has spread, and cannot be removed by surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the Optimal Biological Dose (OBD)

Determine the Recommended Phase 2 Dose

Incidence of Dose Limiting Toxicities

+2 more

Secondary outcome measures

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

Overall Response Rate (ORR)

+3 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Dose Expansion: PDACExperimental Treatment1 Intervention

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.

Group II: Dose Expansion: NSCLCExperimental Treatment1 Intervention

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.

Group III: Dose Expansion: CRCExperimental Treatment1 Intervention

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.

Group IV: Dose Expansion: Adv Solid TumorsExperimental Treatment1 Intervention

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.

Group V: Dose EscalationExperimental Treatment1 Intervention

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 biological dose and recommended phase 2 dose will be determined.

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Affini-T Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

31 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this clinical study?

"Indeed, the information on clinicaltrials.gov confirms that this research trial is actively enrolling subjects. This study was initially listed on February 2nd, 2024 and underwent its latest revision on the same day. The aim is to recruit 100 participants from a single site."

Answered by AI

Are researchers currently seeking participants for this ongoing clinical trial?

"Indeed, the details on clinicaltrials.gov show that this particular clinical study is actively seeking volunteers. The trial was initially shared on February 2nd, 2024 and had its latest update also on the same date. It aims to enroll a total of 100 participants from one designated site."

Answered by AI

What are the specific objectives of this research study?

"As per the details provided by Affini-T Therapeutics, Inc., this trial's primary aim is to establish the Optimal Biological Dose (OBD) within a 5-year timeframe. Aside from this key focus, secondary objectives encompass evaluating Time to Response (TTR), defined as the duration between initial AFNT-211 infusion and first confirmation of Partial Response or better; Clinical Benefit Rate (CBR), gauging the ratio of participants achieving Partial or Complete Response, along with those maintaining Stable Disease for at least six months; and Duration of Response (DOR), reflecting the timespan from initial verification of Partial Response or superior"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06105021.

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