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CAR T-cell Therapy

AFNT-211 for Solid Tumors

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

Must not have

History of treated primary immunodeficiency, autoimmune, or inflammatory disease

Uncontrolled active bacterial, viral, fungal, or mycobacterial infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had treatment for an immune or inflammatory condition.

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I do not have any ongoing serious infections.

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I have had surgery or a procedure involving a catheter.

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I do not have any severe illnesses that are not under control.

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I am HIV positive.

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I have had gene therapy with an integrating vector before.

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I have a primary brain tumor.

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My cancer has spread to my brain or spinal cord and hasn't been treated.

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I was diagnosed with another cancer within the last 2 years.

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I have tested positive for hepatitis B.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the Optimal Biological Dose (OBD)

Determine the Recommended Phase 2 Dose

Incidence of Dose Limiting Toxicities

+2 more

Secondary study objectives

Clinical Benefit Rate (CBR)

Duration of Response (DOR)

Overall Response Rate (ORR)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 16Eligibility criteria met