Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
15 participants
INTERVENTIONAL
2025-07-25
2029-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcoma
This is a non-comparative, open-label trial with different cohorts investigating IMA203 in combination with mRNA-4203.
IMA203
Following non-myeloablative chemotherapy for lymphodepletion (LD) with fludarabine (FLU) and cyclophosphamide (CY), participants will receive a single infusion of IMA203 on Day 1 and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion.
mRNA-4203
mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1.
Interventions
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IMA203
Following non-myeloablative chemotherapy for lymphodepletion (LD) with fludarabine (FLU) and cyclophosphamide (CY), participants will receive a single infusion of IMA203 on Day 1 and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion.
mRNA-4203
mRNA-4203 will be administered starting on Day 15 after IMA203 infusion at the earliest. mRNA-4203 will be given for 12 cycles (28 day cycle length); during Cycle 1 it will be given on Day 1 and Day 15 and in Cycles 2-12 it will be given on Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HLA-A\*02:01 positive
* Adequate selected organ function per protocol
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
* Life expectancy more than 5 months
* CM participants who must have disease progression (resistance, toxicity) on or after at least one PD-1 inhibitor
* SS participants must have received (or declined) at least one line of treatment (including SoC) and are still in need of further systemic therapy.
* Female participants of childbearing potential must use adequate contraception prior to trial entry until 12 months after the infusion of IMA203 and 15 days after the last mRNA 4203 dose administration
Exclusion Criteria
* Pregnant or breastfeeding
* Serious autoimmune disease
* History of cardiac conditions as per protocol
* Prior allogenic stem cell transplantation or solid organ transplantation
* Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
* History of hypersensitivity to cyclophosphamide, fludarabine, or IL-2
* History of hypersensitivity to mRNA-based medicines
* Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection
* Any condition contraindicating leukapheresis
* Participants with lactate dehydrogenase (LDH) greater than threshold allowed per protocol
* Participants with active brain metastases prior to lymphodepletion
* Concurrent treatment in another clinical trial or a device trial that could interfere with the IMA203 treatment
* Participants with renal impairment AND reduced bone marrow reserve per protocol
18 Years
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Immatics US, Inc.
INDUSTRY
Responsible Party
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Locations
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University of California San Francisco
San Francisco, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Karam Khaddour, MD
Role: primary
Other Identifiers
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IMA203-102
Identifier Type: -
Identifier Source: org_study_id
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