Autologous T cell therapy for PRAME+ advanced solid tumors in HLA-A*02+ patients: a phase 1 trial.
Martin Wermke, Dejka M Araujo, Manik Chatterjee...
https://pubmed.ncbi.nlm.nih.gov/40205198Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID03686124
Phase 1/2 Study of Genetically Modified Autologous T Cells Targeting PRAME as Monotherapy or With Nivolumab in Recurrent/Refractory Solid Tumors
Led by Immatics US, Inc. · Updated on 2026-05-13
375
Participants Needed
21
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of genetically modified T-cell therapies called IMA203 and IMA203CD8, used alone or combined with the drug nivolumab, in patients with solid tumors that express a specific antigen known as PRAME. This study focuses on patients with recurrent or refractory solid tumors who have limited treatment options and aims to understand how well these therapies are tolerated and their effects on tumors. The trial includes adult patients who meet specific health and tumor criteria, including a positive HLA type and tumor antigen expression confirmed by a specialized diagnostic test. The study begins with screening that includes HLA testing and tumor tissue analysis. Eligible patients undergo leukapheresis to collect white blood cells, which are genetically modified to produce the IMA203 or IMA203CD8 products. Before receiving the cell infusion, patients undergo lymphodepletion with chemotherapy drugs cyclophosphamide and fludarabine to help the modified cells persist longer. The cell therapy is then infused in the hospital, followed by a low dose of IL-2 injections for up to 10 days if applicable. In one group, patients also receive nivolumab intravenously after the cell therapy. The study has multiple treatment groups with different dosing strategies and combinations. Participants are closely monitored throughout treatment and follow-up, which lasts up to five years after infusion. Assessments include tumor response evaluations, safety checks for side effects, and tests to measure the persistence of the modified T cells. Quality of life is also evaluated over time. This long-term follow-up helps researchers understand the therapy’s effects and any lasting impacts. The study does not involve randomization or blinding, and patients continue to receive care while enrolled in the trial.
CONDITIONS
Brief Title
ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years and older
- Patients with recurrent, progressing, and/or refractory solid tumors
- Must have received or be ineligible for all available standard treatments
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Positive for HLA-A*02:01
- Tumor must express the target antigen as confirmed by IMADetect® RT-qPCR
- Measurable disease by RECIST 1.1 criteria
- Adequate organ function as defined by the protocol
- Life expectancy of more than 5 months
- Female patients of childbearing potential must use adequate contraception until 12 months after infusion
- Male patients must use effective contraception or be abstinent during the study and for 6 months after infusion
- Recovered from side effects of prior treatments to Grade 1 or lower before lymphodepletion
You will not qualify if you...
- History of other malignancies within the last 3 years except treated basal or squamous cell carcinoma or carcinoma in situ
- Pregnant or breastfeeding
- Serious autoimmune disease unless well controlled without immunosuppressive agents
- History of cardiac conditions as defined by protocol
- Prior stem cell or solid organ transplantation
- Severe or uncontrolled medical diseases that could impair study participation
- History of immunodeficiency or prior treatments compromising immune function
- Positive for HIV or active hepatitis B or C infection
- Elevated LDH greater than twice the upper limit of normal
- Conditions preventing leukapheresis, lymphodepletion, IL-2, or IMA203/IMA203CD8 treatment
- Active brain metastases
- Concurrent participation in another clinical trial
- History of severe immune-related toxicities from prior PD-1/PD-L1 inhibitors
- Other protocol-defined criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for HLA screening and biopsy or archival tumor tissue collection
Manufacturing
Duration - Several weeks during product manufacturing
Participants' white blood cells are collected by leukapheresis to manufacture the IMA203 or IMA203CD8 products.
1 leukapheresis visit (in-person)
Treatment
Duration - Approximately 10 days including lymphodepletion, infusion, and IL-2 dosing
Participants undergo lymphodepletion followed by infusion of the IMA203 or IMA203CD8 product. Some participants receive low dose IL-2 injections and/or nivolumab depending on cohort.
Multiple visits including hospital admission for infusion and subcutaneous IL-2 injections until day 10; nivolumab infusions if applicable
Follow-up
Duration - Up to 5 years post infusion
Participants are monitored closely after treatment for safety, tumor response, and persistence of T cells for up to 5 years post infusion.
Regular follow-up visits for monitoring and assessments over 5 years
Trial Site Locations
Total: 21 locations
1
Stanford Cancer Institute
Stanford, California, United States, 94305
Actively Recruiting
2
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Miami Hospital and Clinics
Miami, Florida, United States, 33136
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Columbus, Ohio, United States, 43026
Actively Recruiting
8
University of Pennsylvania, Perelamn Center for Advanced Medicine
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Thomas Jefferson University, Honickman Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
10
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
11
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
12
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
13
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
14
Universitätsklinikum Heidelberg, Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
15
Klinikum rechts der Isar der Technischen Universität München
Munich, Bavaria, Germany, 81675
Actively Recruiting
16
Universitätsklinikum Würzburg
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
17
Universitätsklinikum Bonn - Medizinische Klinik III
Bonn, North Rhine-Westphalia, Germany, 53127
Actively Recruiting
18
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
19
Universitätsklinikum C.-G.-Carus Dresden
Dresden, Saxony, Germany, 01307
Actively Recruiting
20
Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie
Berlin, Germany, 12203
Actively Recruiting
21
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Actively Recruiting
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Research Team
I
Immatics US, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
12
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