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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
All Individual Drugs Already Approved
No Placebo-Only Group

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 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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

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
~200 spots leftby Dec 2028
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