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| Name | Class |
|---|---|
| ModernaTX, Inc. | INDUSTRY |
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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).
This clinical trial is a multi-center, open-label, non-comparative Phase 1 a/b trial to assess the safety, tolerability, and anti-tumor activity of the combination of IMA203 and mRNA-4203 in HLA-A*02:01 positive patients with previously treated, unresectable or metastatic cutaneous melanoma (CM) and synovial sarcoma (SS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMA203 with mRNA-4203 in participants with metastatic cutaneous melanoma or synovial sarcoma | Experimental | This is a non-comparative, open-label trial with different cohorts investigating IMA203 in combination with mRNA-4203. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with dose-limiting toxicities (DLTs) | Number of DLTs will be used to determine the maximum tolerated dose (MTD) and/or recommended dose for extension (RDE) after treatment with IMA203 product in combination with mRNA-4203 | one year post infusion of IMA203 |
| Number of treatment emergent adverse events (AEs), AEs of special interest, serious AEs (SAEs), changes in laboratory parameters and vital signs, and frequency of dose interruptions, reductions and discontinuations | Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203 | one year post infusion of IMA203 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | complete response (CR) and partial response (PR) based on best overall response (BOR), locally assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | one year post infusion of IMA203 |
| Duration of response (DOR) |
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Inclusion Criteria:
Other protocol defined inclusion criteria could apply
Exclusion Criteria:
Other protocol defined exclusion criteria could apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Immatics US, Inc. | Contact | +1 346 204-5400 | ctgovinquiries@immatics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco | Recruiting | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D013584 | Sarcoma, Synovial |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| 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. |
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CR and PR, locally assessed using RECIST v1.1 |
| one year post infusion of IMA203 |
| Disease control rate (DCR) | CR, PR and stable disease (SD) lasting 6 or more weeks following the infusion of IMA203, locally assessed using RECIST v1.1 | one year post infusion of IMA203 |
| Progression-free survival (PFS) | locally assessed using RECIST v1.1 | one year post infusion of IMA203 |
| Concentration of IMA203 transgene in peripheral blood | Evaluate the pharmacokinetics of T-cell receptor (TCR) engineered T cells in combination with mRNA-4203 | one year post infusion of IMA203 |
| Dana Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D012509 | Sarcoma |