ACTengine® IMA203 Combined With mRNA-4203

Part of paid clinical trials in San Francisco, California.

Sponsor
Immatics US, Inc.
Study ID
NCT06946225
Phase
PHASE1
Status
Recruiting
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Conditions

  • Cutaneous Melanoma
  • Synovial Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMA203 — BIOLOGICAL
    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 — BIOLOGICAL
    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.

Study Details

This purpose of this clinical trial is to evaluate the safety, tolerability and anti-tumor activity of IMA203 in combination with different doses of mRNA-4203. The trial includes participants with previously treated unresectable or metastatic cutaneous melanoma (CM) or synovial sarcoma (SS).

Key Dates

Start date
Jul 25, 2025
Status verified
Jan 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of participants with dose-limiting toxicities (DLTs) [ Time Frame: one year post infusion of IMA203 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Adil Daud, MD
[email protected]
Dana Farber Cancer InstituteBostonMassachusetts02215
Karam Khaddour, MD
Sydney Srnka
[email protected]
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
James Smithy, MD
[email protected]
MD Anderson Cancer CenterHoustonTexas77030
Dejka Araujo, MD
[email protected]
Rodabe Amaria, MD
[email protected]

Find similar trials in San Francisco, CA

By research site
University of California San Francisco· San Francisco, CADana Farber Cancer Institute· Boston, MAMemorial Sloan Kettering Cancer Center· New York, NYMD Anderson Cancer Center· Houston, TX

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