Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IMA203 Product, IMA203 product- flat dose, anzutresgene autoleucel, anzu-cel
IMA203 · 3 trials · 7 indications
progression-free survival (PFS), centrally assessed (by blinded independent central review) using RECIST 1.1
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
Used to evaluate safety and tolerability of treatment with IMA203 in combination with mRNA-4203
Number of patients with dose-limiting toxicities (DLTs)
Treatment emergent adverse events (TEAEs), Adverse events of special interest (AESIs) and Treatment-emergent serious adverse events (TESAEs).
Objective response rate (ORR) based on best overall response (BOR) of complete response (CR) and partial response (PR) centrally assessed (by a BICR1) using RECIST1.1
| Arm | Type | Description |
|---|---|---|
| Experimental arm | EXPERIMENTAL | Non-myeloablative chemotherapy for lymphodepletion (LD) over 4 days using fludarabine (FLU) and cyclophosphamide (CY), one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy |
| Control arm- investigator's choice | ACTIVE_COMPARATOR | Investigator's choice of treatment approved by the respective Competent Authority (nivolumab plus relatlimab \[Opdualag®\], lifileucel, nivolumab, pembrolizumab, ipilimumab, or chemotherapy \[e.g., dacarbazine, temozolomide, paclitaxel, alb-bound paclitaxel, or paclitaxel plus carboplatin\]) as determined by the site investigator in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC), optional bridging therapy. |
| 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. |
| Dose Escalation A (closed to enrollment) | EXPERIMENTAL | Dose escalation of IMA203 |
| Extension Cohort A | EXPERIMENTAL | IMA203 at RP2D |
| Extension Cohort B (closed to enrollment) | EXPERIMENTAL | IMA203 at RP2D + nivolumab |
| Extension Cohort AA | EXPERIMENTAL | IMA203 at final RP2D (flat dose) |
| Uveal Melanoma | EXPERIMENTAL | IMA203 at RP2D |
| Dose Escalation B | EXPERIMENTAL | Dose escalation of IMA203CD8 |
| Extension Cohort C | EXPERIMENTAL | IMA203CD8 at dose levels confirmed to be safe |
| Extension Cohort D | EXPERIMENTAL | IMA203CD8 at dose levels confirmed to be safe; without IL-2 |
| Ovarian | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Endometrial | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Head and Neck, Lung, and Triple Negative Breast Cancer | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Rare Cancers | EXPERIMENTAL | IMA203CD8 monotherapy at dose levels confirmed to be safe |
| Name | Type | Description |
|---|---|---|
| IMA203 | BIOLOGICAL | one-time administration of IMA203, and adjunctive therapy with low dose interleukin (IL)-2 for up to 10 days, starting approximately 24 h after IMA203 infusion, optional bridging therapy |
| nivolumab plus relatlimab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| lifileucel | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| nivolumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| pembrolizumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| ipilimumab | BIOLOGICAL | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| Dacarbazine | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| temozolomide | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| paclitaxel | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| paclitaxel plus carboplatin | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| Albumin-Bound Paclitaxel | DRUG | in accordance with current respective prescribing information (PI) and/or summary of product characteristics (SmPC) |
| 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. |
| IMA203 Product | BIOLOGICAL | The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula |
| IMA203 product- flat dose | BIOLOGICAL | The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells |
| IMA203CD8 Product | BIOLOGICAL | The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula |
| IMADetect® | DEVICE | IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials. |
Inclusion Criteria: * Pathologically confirmed and documented cutaneous melanoma- CM patients (including acral melanoma and melanoma of unknown primary) with unresectable or metastatic disease * HLA-A\*02:01 positive * Adequate selected organ function per protocol * Eastern Cooperative Oncology Gro...
IMA203 is an investigational cell therapy being developed by Immatics N.V. for the treatment of solid tumors, including cutaneous melanoma and refractory cancers. It is designed to target PRAME, a protein expressed in several tumor types. IMA203 is currently in clinical development and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA.
IMA203 is being studied for the treatment of cutaneous melanoma, including previously treated, unresectable or metastatic cutaneous melanoma, as well as refractory cancers and other solid tumors. It is also being evaluated in synovial sarcoma in combination with mRNA-4203. IMA203 is investigational and has not been approved for any indication.
IMA203 targets PRAME, a cancer-testis antigen that is overexpressed in multiple solid tumors, including melanoma. By targeting PRAME, IMA203 aims to direct a T cell response against PRAME-positive tumor cells. This mechanism is being evaluated in clinical trials for patients with PRAME-expressing cancers.
IMA203 is being developed by Immatics N.V., a clinical-stage biopharmaceutical company focused on T cell receptor therapies. Immatics trades on the Nasdaq under the ticker symbol IMTX. The company is conducting multiple clinical trials of IMA203, including a Phase 3 study in cutaneous melanoma.
IMA203 is in Phase 1 and Phase 3 clinical development. The Phase 3 trial, SUPRAME, is evaluating IMA203 versus investigator's choice of treatment in previously treated, unresectable or metastatic cutaneous melanoma. IMA203 is investigational and has not been approved by the FDA.
IMA203 is being studied in three recruiting trials: NCT06946225, a Phase 1 trial combining IMA203 with mRNA-4203 in cutaneous melanoma and synovial sarcoma; NCT06743126, a Phase 3 trial in cutaneous melanoma; and NCT03686124, a Phase 1 trial in refractory solid tumors. These trials are enrolling adult patients.
IMA203 is also known as IMA203 Product or IMA203 product-flat dose. These names refer to the same investigational therapy developed by Immatics N.V. for PRAME-positive solid tumors. The different naming reflects product formulations or dosing descriptions used in clinical development.