TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine)

Status: Active

Description

The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors.

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria: - Signed a written informed consent form(s). - ECOG performance status 0-1. - Women of childbearing potential must use adequate contraception (hormonal or barrier method of birth control; abstinence). HLA INCLUSION • Pathologically confirmed advanced/metastatic solid tumors such as one of the following indications: - Pathologically confirmed diagnosis of stage IIIB/IV recurrent NSCLC - Pathologically confirmed diagnosis of stage III/IV recurrent or metastatic HNSCC (oral cavity, pharynx, larynx) MAIN SCREENING & LEUKAPHERESIS INCLUSION - Pathologically confirmed advanced/metastatic solid tumors such as one of the following indications: - Pathologically confirmed diagnosis of stage IIIB/IV recurrent NSCLC - Pathologically confirmed diagnosis of stage III/IV recurrent or metastatic HNSCC (oral cavity, pharynx, larynx) - HLA phenotype positive NOTE: Patients who were previously HLA-typed for participation in other Immatics' sponsored clinical trials and were HLA phenotype positive may enter IMA201-101 main screening - Patient's tumor must express specified biomarkers. NOTE: Patients who were previously screened for participation in other Immatics' sponsored clinical trials and whose biomarkers are positive for IMA201-101 based on IMA_Detect may enter IMA201-101 screening - Recommended acceptable organ and marrow function, defined per protocol - Measurable disease - At least one lesion (metastasis or primary tumor) being considered accessible for a biopsy. - Adequate hepatic function, as defined per protocol - Serum creatinine within 1.5 x normal range for age OR creatinine clearance with a recommended GFR ≥ 50 mL/min/1.73m2. - Adequate pulmonary function, defined per protocol and oxygen saturation >92% on room air. - Acceptable coagulation status: INR ≤2.0 x ULN and PTT ≤2.0 x ULN. - Confirmed availability of production capacities for the patient's ACTengine IMA201 product prior to the leukapheresis. TREATMENT INCLUSION: Patients may enter the treatment phase if: - Disease recurs/progresses - Disease becomes refractory or previous anti-cancer treatment is no longer warranted - Available IMA201 T-cell product that was produced for the patient and passed all release tests. - Adequate hepatic function per protocol. - Serum creatinine within 1.5 x normal range for age or creatinine clearance with a recommended GFR ≥ 50 mL/min/1.73m2. - Measurable disease - Male patients must agree to use effective contraception or be abstinent while on study and for 90 days after the infusion of IMA201. Exclusion Criteria: • Pregnant or is breastfeeding. HLA EXCLUSION: - History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years. - Serious autoimmune disease MAIN SCREENING EXCLUSION: - Any condition contraindicating leukapheresis. - Brain metastases. - HIV infection, active Hepatitis B or C infection - Concomitant therapy indicated with any of the following: interferons or other non-study immunotherapy regimens; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids. - Severe immune-related toxicities related to checkpoint inhibitors defined per protocol. - Cardiac conditions per protocol - Prior stem cell transplantation or solid organ transplantation. - Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study - Active diverticulitis, intra-abdominal abscess or gastrointestinal (GI) obstruction. - History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years. - Serious autoimmune disease - History of hypersensitivity to cyclophosphamide, fludarabine or IL-2. - History of or current immunodeficiency disease or prior treatment compromising immune function - Patients with active pneumonitis. - Investigator's judgment TREATMENT EXCLUSION - Received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks (4 weeks for monoclonal antibodies or investigational drugs, 1 week for tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib) or the patient has not recovered (from grade ≥2 side effects of the previous therapy) prior to lymphodepletion regimen. - Active pneumonitis. - Patient unable to tolerate lymphodepletion, low-dose IL-2 and/or ACTengine IMA201 treatment. - Severe immune-related toxicities related to checkpoint inhibitors defined per protocol. - Investigator's judgment

Locations & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available

Trial Objectives and Outline

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) screening and the main biomarkers screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA201 product. MANUFACTURING: IMA201 product will be made from the patient's white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA201 infusion to improve the duration of time that IMA201 stays in the body. After IMA201 infusion, a low dose of IL-2 will be given twice daily for a period of time. Since this study involves gene therapy, patients will be monitored throughout the study and for up to a total of 15 years.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Immatics US, Inc.

Trial IDs

Primary ID IMA201-101
Secondary IDs NCI-2018-00208
Clinicaltrials.gov ID NCT03247309