TCR-engineered T Cells in Solid Tumors (ACTengine IMA201-101)

NCT03247309 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: IMA201-101
• Study Type: interventional
• Target: 7
• Locations: 2 countries
• Sites: 5

Brief Summary

The study purpose is to establish the safety and tolerability of IMA201 in patients with solid tumors that express melanoma-associated antigen 4 and/or 8 (MAGEA4/8).

Conditions

Solid Tumor; Cancer; Recurrent Solid Tumors; Refractory Solid Tumors

Keywords

T-cell therapy; immunotherapy; adoptive cellular therapy; T-Cell Receptor; IMA201; Cytotherapy; Cell Therapy; Gene Therapy

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AE)

  up to 3 years post-treatment

• Determination of the maximum tolerated dose (MTD)

  until 21 days post treatment

Secondary Outcomes (2)

• Duration of infused T cells over time (Persistence of T cells)

  up to 3 years post-treatment

• Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)

  up to 12 months

Study Arms (1)

IMA201 Product

EXPERIMENTAL

* Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * One dose of IMA201 product will be infused intravenously. Up to four dose levels will be evaluated. At least two patients per cohort will be treated. * Post-infusion of IMA201 product, administration of low-dose recombinant human interleukin-2

Biological: IMA201 Product; Diagnostic Test: IMADetect®

Interventions

IMA201 Product BIOLOGICAL

The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.

IMA201 Product

IMADetect® DIAGNOSTIC_TEST

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 clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.

IMA201 Product

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years of age
• Pathologically confirmed advanced and/or metastatic solid tumor
• Patients may enter screening procedure before, during, or after the last available indicated standard of care treatment. There is no limitation for prior anti cancer treatments.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• HLA phenotype positive for the study
• Patients must have measurable disease according to RECIST 1.1
• Disease accessible to biopsy
• Adequate pulmonary function per protocol
• Adequate organ and bone marrow function per protocol
• Acceptable coagulation status per protocol
• Adequate hepatic function per protocol
• Adequate renal function per protocol
• Patient's tumor must express tumor antigen by qPCR using a fresh tumor biopsy specimen
• Life expectancy more than 3 months
• Confirmed availability of production capacities for IMA201 product

You may not qualify if:

• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
• Solid tumors with low likelihood of tumor biomarker expression per protocol
• 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 hypersensitivity to cyclophosphamide (CY), fludarabine (FLU), or IL-2, or to any of the rescue medications
• History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
• HIV infection, active hepatitis B virus (HBV), active hepatitis C virus (HCV) infection, ongoing active anti-HCV treatment or detectable HBV or HCV viral load at the most recent laboratory report. Patients with both HBV and HCV infections will be excluded from screening
• Patients with a history of HCV infection and with an undetectable viral load per the most recent laboratory report and/or completed anti-HCV treatment but are HCV antibody positive are permitted.
• History of treated HBV infection is permitted if the viral load is undetectable per the most recent laboratory report. Note: HCC patients with controlled HBV infection, as defined by resolved (anti-hepatitis B surface antigen \[HBs-Ag\] antibody (Ab) negative, anti-core antigen \[HBc Ag\] Ab positive) or chronic stable (anti HBs-Ag Ab positive) HBV infection will be eligible for screening. Patients with active HBV infection who are not on anti-HBV treatment will be excluded.
• Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA201 treatment
• Patients with any active viral infection
• Patients with active brain metastases

Sponsors & Collaborators

• Immatics US, Inc.: lead

Study Sites (5)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Universitätsklinikum Bonn, Venusberg-Campus 1

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitätsklinikum Carl Gustav Carus, Fetscherstr. 74

Dresden, Saxony, 01307, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (1)

• Fritsche J, Rakitsch B, Hoffgaard F, Romer M, Schuster H, Kowalewski DJ, Priemer M, Stos-Zweifel V, Horzer H, Satelli A, Sonntag A, Goldfinger V, Song C, Mahr A, Ott M, Schoor O, Weinschenk T. Translating Immunopeptidomics to Immunotherapy-Decision-Making for Patient and Personalized Target Selection. Proteomics. 2018 Jun;18(12):e1700284. doi: 10.1002/pmic.201700284. Epub 2018 Apr 10.

  PMID: 29505699 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• Cedrik Britten, MD, PhD

  Immatics US, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 11, 2017
• Study Start: December 19, 2018
• Primary Completion: April 20, 2023
• Study Completion: September 18, 2023
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (3); US (2)