Phase 1/2 study evaluating genetically modified autologous T cells expressing a T-cell receptor recognizing a cancer/germline antigen as monotherapy or in combination with nivolumab in patients with recurrent and/or refractory solid tumors (ACTengine® IMA203-101)

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-515114-41-00

Acronym

IMA203-101

Enrollment

272

Registered

2024-08-27

Start date

2020-08-10

Completion date

Unknown

Last updated

2025-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid tumors

Brief summary

Treatment-emergent adverse events (TEAEs) (Phase I/II), Adverse Events of special interest (AESIs) (Phase I/II), Serious TEAEs (Phase I/II), Number of patients with dose-limiting toxicities (Phase I), Objective response rate based on best overall response of complete response and partial response centrally assessed using RECIST 1.1 (Phase II)

Interventions

DRUGIMA203

DRUGOPDIVO 10 mg/mL concentrate for solution for infusion.

DRUGIMA203CD8

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Treatment-emergent adverse events (TEAEs) (Phase I/II), Adverse Events of special interest (AESIs) (Phase I/II), Serious TEAEs (Phase I/II), Number of patients with dose-limiting toxicities (Phase I), Objective response rate based on best overall response of complete response and partial response centrally assessed using RECIST 1.1 (Phase II)	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 5, 2026