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) - ACTengine® IMA203/IMA203CD8 in recurrent and/or refractory solid tumors

Immatics US InC0 sites476 target enrollmentAugust 22, 2019

Overview

No summary available.

Registry

who.int

Start Date

August 22, 2019

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Eligibility Criteria: Initial Screening (HLA Screening, Biomarker Screening, and Leukapheresis):
•1\. Patient must have voluntarily signed a written ICF1
•2\.Patient must have pathologically confirmed advanced and/or metastatic solid tumor.
•3\.Patients \= 18 years of age
•4\.ECOG PS 0 to 1
•5\.HLA phenotype: HLA\-A\*02:01 positive
•6\.The patient has adequate pulmonary function.
•7\.The patient has adequate organ and marrow function
•8\.Acceptable coagulation status
•9\.The patient has adequate hepatic and renal function

•Eligibility Criteria: Initial Screening (HLA Screening, Biomarker Screening, and Leukapheresis):
•1\.History of other malignancies
•2\. Solid tumors indications with low target prevalence as indicated by the sponsor
•3\.The patient is pregnant or is breastfeeding
•4\.Patients with prior allogenic stem cell transplantation or solid organ transplantation
•5\.History of hypersensitivity to CY, FLU or IL\-2 and Rescue medication
•6\.The patient has received systemic corticosteroids within 2 weeks prior to leukapheresis. The patient has received other anti\-tumor therapies.
•7\.The patient has concurrent severe and/or uncontrolled medical disease
•8\.Any other condition that would, in the investigator’s or sponsor’s judgment, contraindicate the patient’s participation in the clinical study
•9\. Patient with any active infection (e.g., COVID\-19, influenza, SARS)