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CAR T-cell Therapy

IMA203/IMA203CD8 + Nivolumab for Cancer (ACTengine Trial)

Phase 1

Recruiting

Research Sponsored by Immatics US, Inc.

Eligibility Criteria Checklist

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

Must have

Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Must not have

HIV infection, active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, ongoing active anti-HCV treatment or detectable HBV or HCV viral load at the most recent laboratory report. Patients with both HBV and HCV infections will be excluded from screening

Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203/IMA203CD8 treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?

This trial is for adults with solid tumors that no longer respond to standard treatments and express a specific antigen (PRAME). Participants must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. They should not have other cancers within the last 3 years, serious autoimmune diseases, heart conditions, prior transplants, immune deficiencies, HIV/HBV/HCV infections with detectable viral load, brain metastases over 10 cm in size or severe reactions to similar drugs.

What is being tested?

The study tests IMA203/IMA203CD8 products alone or combined with nivolumab on patients whose tumors express PRAME. It aims to determine the safety and tolerability of these therapies. The trial will measure how well the disease responds according to RECIST criteria which assess tumor shrinkage and growth.

What are the potential side effects?

Potential side effects may include typical reactions related to immunotherapies such as fatigue, skin reactions, inflammation of organs like lungs or intestines (pneumonitis or colitis), hormonal gland issues (like thyroid problems), infusion-related reactions and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My solid tumor cancer is getting worse or not responding to treatment, and I've tried or can't have all standard treatments.

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I am fully active or can carry out light work.

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My HLA type matches the study requirements.

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My tumor expresses a specific antigen detected by a special test.

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I have recovered from previous treatment side effects.

Exclusion Criteria

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

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I do not have HIV, active hepatitis B or C, nor am I currently being treated for hepatitis C.

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I don't have health issues that prevent me from undergoing specific cancer treatments.

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I have had more than 4 treatments for my advanced or metastatic disease.

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I have not had any cancer except for certain skin cancers or localized cancers that are completely treated, in the last 3 years.

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I have a history of heart conditions.

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I have active cancer spread to my brain.

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I have a tumor larger than 10 cm.

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I have never had severe side effects from immune therapy.

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I have had a stem cell or solid organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years 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 MTD and/or recommended dose for extension for IMA203/IMA203CD8

Therapeutic procedure

Secondary study objectives

Persistence of T-cells

Neoplasms

Trial Design

10Treatment groups

Experimental Treatment

Group I: Synovial SarcomaExperimental Treatment2 Interventions

IMA203CD8 monotherapy at dose levels confirmed to be safe

Group II: Ovarian/UterineExperimental Treatment2 Interventions

IMA203CD8 monotherapy at dose levels confirmed to be safe

Group III: Head and Neck, Lung, and Triple Negative Breast CancerExperimental Treatment2 Interventions

IMA203CD8 monotherapy at dose levels confirmed to be safe

Group IV: Extension Cohort DExperimental Treatment2 Interventions

IMA203CD8 at dose levels confirmed to be safe; without IL-2

Group V: Extension Cohort CExperimental Treatment2 Interventions

IMA203CD8 at dose levels confirmed to be safe

Group VI: Extension Cohort BExperimental Treatment3 Interventions

IMA203 at RP2D + nivolumab

Group VII: Extension Cohort AAExperimental Treatment2 Interventions

IMA203 at anticipated final RP2D (flat dose)

Group VIII: Extension Cohort AExperimental Treatment2 Interventions

IMA203 at RP2D

Group IX: Dose Escalation BExperimental Treatment2 Interventions

Dose escalation of IMA203CD8

Group X: Dose Escalation AExperimental Treatment2 Interventions

Dose escalation of IMA203

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

IMADetect®

2019

Completed Phase 1

~30

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

Immatics US, Inc.Lead Sponsor

4 Previous Clinical Trials

303 Total Patients Enrolled

Cedrik Britten, M.D.Study DirectorImmatics US, Inc.

2 Previous Clinical Trials

280 Total Patients Enrolled

Media Library

IMA203/IMA203CD8 Product (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03686124 — Phase 1

Cancer Research Study Groups: Dose Escalation B, Extension Cohort AA, Extension Cohort D, Ovarian/Uterine, Synovial Sarcoma, Head and Neck, Lung, and Triple Negative Breast Cancer, Dose Escalation A, Extension Cohort A, Extension Cohort B, Extension Cohort C

Cancer Clinical Trial 2023: IMA203/IMA203CD8 Product Highlights & Side Effects. Trial Name: NCT03686124 — Phase 1

IMA203/IMA203CD8 Product (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03686124 — Phase 1

~209 spots leftby Dec 2028

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