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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03686124
Other study ID # IMA203-101
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date May 14, 2019
Est. completion date December 2028

Study information

Verified date October 2023
Source Immatics US, Inc.
Contact Immatics US, Inc.
Phone +1 346 204-5400
Email ctgovinquiries@immatics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).


Description:

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening and a biopsy (or collection of archival tumor tissue) for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of an IMA203 or an IMA203CD8 product. MANUFACTURING: IMA203 and IMA203CD8 products will be made from the patients' white blood cells. TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203/IMA203CD8 product infusion to improve the duration of time that IMA203/IMA203CD8 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion. After the IMA203/IMA203CD8 product infusion, a low dose of IL-2 will be given subcutaneously daily for 10 days. In Extension Cohort B (IMA203) nivolumab will be administered intravenously. Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.


Recruitment information / eligibility

Status Recruiting
Enrollment 186
Est. completion date December 2028
Est. primary completion date December 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients must have recurrent/progressing and/or refractory solid tumors and must have received or not be eligible for all available indicated standard of care treatment. - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - HLA phenotype positive for the study - Measurable disease according to RECIST 1.1 - Adequate selected organ function per protocol - Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR - Life expectancy more than 3 months - Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203/IMA203CD8 - Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203/IMA203CD8 - The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion. Exclusion Criteria: - History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years - Pregnant or breastfeeding - Serious autoimmune disease Note: At the discretion of the investigator, these patients may be included if their disease is well controlled without the use of immunosuppressive agents. - History of cardiac conditions as per protocol - Prior stem cell transplantation or solid organ transplantation - Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study - History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician - Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection. - Patients with LDH greater than 2.5-fold ULN. - Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203/IMA203CD8 treatment - Patients with active brain metastases - Concurrent treatment in another clinical trial. - For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.). Other protocol defined inclusion/exclusion criteria could apply

Study Design


Intervention

Biological:
IMA203 Product
The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
IMA203CD8 Product
The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
Device:
IMADetect®
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. IMADetect® is intended for investigational use only.
Drug:
nivolumab (Opdivo®)
Nivolumab will be given post IMA203 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.

Locations

Country Name City State
Germany Charité Benjamin Franklin - Klinik für Hämatologie und Onkologie Berlin
Germany Universitätsklinikum Bonn - Medizinische Klinik III Bonn North Rhine-Westphalia
Germany Universitätsklinikum C.-G.-Carus Dresden Dresden Saxony
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Universitätsklinikum Würzburg Würzburg Bavaria
United States University of Texas MD Anderson Cancer Center Houston Texas
United States University of Miami Hospital and Clinics Miami Florida
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Immatics US, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate safety and tolerability of treatment with treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab Treatment emergent adverse events 35 days
Primary Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 Number of patients with dose-limiting toxicities (DLTs) 28 days
Secondary Persistence of T-cells Measurement of TCR-engineered T cells in peripheral blood up to 5 years post treatment
Secondary Tumor response Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 up to 12 months
Secondary Tumor response Immune-Related Response Evaluation Criteria In Solid Tumors (irRECIST) up to 12 months
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