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CAR T-cell Therapy
TCR-Engineered T Cells for Solid Cancers (ACTengine Trial)
Phase 1
Waitlist Available
Research Sponsored by Immatics US, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years post-treatment
Awards & highlights
ACTengine Trial Summary
This trial is testing a new drug, IMA201, to see if it is safe and works well against solid tumors that express two proteins, MAGEA4 and MAGEA8.
Who is the study for?
Adults with advanced solid tumors expressing MAGEA4/8, who've tried or aren't eligible for standard treatments. They must be over 18, have good organ function and blood coagulation, not pregnant/breastfeeding, no severe immune diseases or infections (HIV/HBV/HCV), and agree to use contraception.Check my eligibility
What is being tested?
The trial tests the safety of IMA201 T cells engineered to target cancer in patients with specific tumor markers. It includes a screening process for eligibility based on tumor antigen expression and requires adequate production capacity for the personalized treatment.See study design
What are the potential side effects?
Potential side effects are not explicitly listed but may include reactions related to immune system modification such as inflammation, infection risk increase due to lymphodepletion therapy used before IMA201 infusion, and typical risks associated with biopsies.
ACTengine Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 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
Determination of the maximum tolerated dose (MTD)
Incidence of adverse events (AE)
Secondary outcome measures
Duration of infused T cells over time (Persistence of T cells)
Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
ACTengine Trial Design
1Treatment groups
Experimental Treatment
Group I: IMA201 ProductExperimental Treatment2 Interventions
Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated.
Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
IMA201 Product
2018
Completed Phase 1
~10
IMADetect®
2019
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Immatics US, Inc.Lead Sponsor
4 Previous Clinical Trials
482 Total Patients Enrolled
Cedrik Britten, MD, PhDStudy DirectorImmatics US, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a severe allergic reaction to cyclophosphamide, fludarabine, IL-2, or any of the rescue medications.You have received a stem cell or organ transplant in the past.You have good lung function according to the study's guidelines.You are expected to live for at least 3 more months.You have a medical condition that makes leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA201 treatment unsafe for you.You have cancer that has spread to your brain and is currently causing symptoms.You have had any other types of cancer, except for certain types that have been treated successfully.
Research Study Groups:
This trial has the following groups:- Group 1: IMA201 Product
Awards:
This trial has 1 awards, including:- 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 there still enrollees being accepted into this investigation?
"The details posted on clinicaltrials.gov show that this trial is currently enrolling patients, having initially been announced in December of 2018 and last updated on the 28th of 2021."
Answered by AI
What evidence is there to suggest that IMA201 Product can be safely administered?
"The IMA201 Product's safety rating is a 1, as this clinical trial only involves preliminary data collection with regards to efficacy and security."
Answered by AI
How many individuals have joined this experimental protocol?
"Immatics US, Inc. is in need of 22 participants that meet the eligibility requirements for this medical trial and will be running it from multiple sites such as Columbia University Medical Center in New york City and University of Pittsburgh Medical Center in Pittsburg."
Answered by AI
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