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)
-To evaluate safety and tolerability of treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab -To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) for IMA203/IMA203CD8
Why this Research Matters
This clinical study is a multicenter, open-label, 3 + 3, dose-escalation/de-escalation, FIH Phase 1/2 study to evaluate the safety, tolerability, and anti-tumor activity of treatment with IMA203/IMA203CD8 (autologous PRAME-specific T cells) in patients with PRAME-positive recurrent and/or refractory solid tumors
Who can Participate
Inclusion: -Patients must have pathologically confirmed uveal melanoma. -HLA phenotype: HLA-A*02:01 positive -Patients may have been treated with up to one prior line of therapy for the treatment of unresectable or metastatic disease as clinically indicated at the discretion of the Investigator. Exclusion: -History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years - More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.
Study ID
Protocol Number: 25-2206
More information available at ClinicalTrials.gov: NCT03686124
Meet the Team
Principal Investigator