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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years post treatment
Awards & highlights
ACTengine Trial 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.Check my eligibility
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.See study design
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.
ACTengine Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
ACTengine Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8
Therapeutic procedure
Secondary outcome measures
Persistence of T-cells
Neoplasms
ACTengine Trial Design
5Treatment groups
Experimental Treatment
Group I: Extension Cohort CExperimental Treatment2 Interventions
IMA203CD8 at provisional RP2D
Group II: Extension Cohort BExperimental Treatment3 Interventions
IMA203 at RP2D + nivolumab
Group III: Extension Cohort AExperimental Treatment2 Interventions
IMA203 at RP2D
Group IV: Dose Escalation BExperimental Treatment2 Interventions
Dose escalation of IMA203CD8
Group V: 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have HIV, active hepatitis B or C, nor am I currently being treated for hepatitis C.I don't have health issues that prevent me from undergoing specific cancer treatments.My solid tumor cancer is getting worse or not responding to treatment, and I've tried or can't have all standard treatments.I have had more than 4 treatments for my advanced or metastatic disease.I have not had any cancer except for certain skin cancers or localized cancers that are completely treated, in the last 3 years.I have a history of heart conditions.I have active cancer spread to my brain.I am fully active or can carry out light work.My HLA type matches the study requirements.I am using birth control and will continue for 12 months after my treatment.I agree to use contraception or remain abstinent for 6 months after my treatment.I have recovered from previous treatment side effects.I have a tumor larger than 10 cm.My tumor expresses a specific antigen detected by a special test.I have never had severe side effects from immune therapy.I have had a stem cell or solid organ transplant.My organs are functioning well enough for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation B
- Group 2: Dose Escalation A
- Group 3: Extension Cohort A
- Group 4: Extension Cohort B
- Group 5: Extension Cohort C
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are enrollment opportunities still available for this experiment?
"Affirmative. According to clinicaltrials.gov, the research trial initiated on May 14th 2019 is still open and actively seeking enrollees. The study aims to recruit 102 people from three locations by August 11th 2022."
Answered by AI
What conditions is Atezolizumab typically prescribed for?
"According to current medical literature, Atezolizumab is an effective therapy for small cell lung cancer (sclc), malignant neoplasms and non-small cell lung carcinoma."
Answered by AI
How likely are side effects to occur with Atezolizumab treatment?
"A score of 1 was assigned for Atezolizumab's safety due to its status as a Phase 1 trial, meaning there is only minimal data available in regards to efficacy and protection."
Answered by AI
What prior experiences can be drawn upon for Atezolizumab trials?
"Atezolizumab was first evaluated in 2008 at SCRI Tennessee Oncology Chattanooga, and 81 studies have been successfully completed since. There are 350 additional clinical trials currently underway; the majority of these investigations taking place in New york City."
Answered by AI
What sample size is being used to evaluate the efficacy of this trial?
"This trial necessitates the inclusion of 102 eligible patients. These participants can enroll from either Columbia University Medical Center in New york, NY or University of Pittsburgh Medical Center in Pennsylvania's largest city."
Answered by AI
Is this a pioneering trial or have similar experiments been conducted in the past?
"Since its initial research in 2008, sponsored by Hoffmann-La Roche and involving 720 participants, Atezolizumab has undergone vast clinical trials. Currently there are 350 ongoing studies taking place across 1646 cities and 74 countries that have lead to the drug gaining Phase 2 approval."
Answered by AI
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