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History of Changes for Study: NCT03686124
ACTengine® IMA203 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (ACTengine)
Latest version (submitted October 23, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 September 25, 2018 None (earliest Version on record)
2 October 4, 2018 Study Status
3 March 14, 2019 Study Status and Oversight
4 April 22, 2019 Recruitment Status, Study Status and Contacts/Locations
5 April 26, 2019 Contacts/Locations and Study Status
6 June 6, 2019 Study Status
7 June 21, 2019 Contacts/Locations and Study Status
8 July 12, 2019 Contacts/Locations and Study Status
9 December 12, 2019 Study Status and Study Description
10 January 10, 2020 Study Status
11 February 26, 2020 Study Status and Contacts/Locations
12 August 12, 2020 Outcome Measures, Arms and Interventions, Contacts/Locations, Study Status, Study Design, Eligibility, Study Description, Sponsor/Collaborators and Study Identification
13 September 3, 2020 Study Status and Contacts/Locations
14 April 8, 2021 Study Status and Contacts/Locations
15 July 7, 2021 Arms and Interventions, Contacts/Locations, Study Description, Study Status, Eligibility, Study Design and Study Identification
16 August 19, 2021 Study Status and Contacts/Locations
17 September 10, 2021 Contacts/Locations and Study Status
18 May 24, 2022 Arms and Interventions, Study Status, Outcome Measures, Study Description, Study Identification and Eligibility
19 August 11, 2022 Outcome Measures, Arms and Interventions, Contacts/Locations, Study Description, Study Status, Eligibility, Study Design and Study Identification
20 February 2, 2023 Study Status and Contacts/Locations
21 August 21, 2023 Arms and Interventions, Contacts/Locations, Study Status, Eligibility, Study Design, Conditions and Study Description
22 October 23, 2023 Study Status and Contacts/Locations
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Study NCT03686124
Submitted Date:  May 24, 2022 (v18)

Open or close this module Study Identification
Unique Protocol ID: IMA203-101
Brief Title: ACTengine® IMA203 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors (ACTengine)
Official Title: Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a TCR Recognizing a Cancer/Germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Recruiting
Study Start: May 14, 2019
Primary Completion: December 2028 [Anticipated]
Study Completion: December 2028 [Anticipated]
First Submitted: September 25, 2018
First Submitted that
Met QC Criteria:
September 25, 2018
First Posted: September 26, 2018 [Actual]
Last Update Submitted that
Met QC Criteria:
May 24, 2022
Last Update Posted: May 27, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Immatics US, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: The study purpose is to establish the safety and tolerability of IMA203 product with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).
Detailed Description:

SCREENING: Patient eligibility will be determined by protocol inclusion/exclusion criteria including HLA (human leukocyte antigen) screening and a biopsy for biomarker screening. If the patient is eligible, white blood cells will be taken during leukapheresis for the manufacture of the IMA203 product.

MANUFACTURING: IMA203 product will be made from the patient's white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA203 product infusion to improve the duration of time that IMA203 product stays in the body. The patient will be admitted to the hospital during the T-cell infusion.

After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously daily for 10 days.

In Extension Cohort B (IMA203 plus nivolumab), nivolumab will be administered intravenously.

Patients will be monitored closely throughout the study. The follow-up phase ends 5 years post infusion.

Open or close this module Conditions
Conditions: Refractory Cancer
Recurrent Cancer
Solid Tumor, Adult
Cancer
Keywords: T-cell therapy
immunotherapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 3
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 42 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dose Escalation
Dose escalation of IMA203
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.
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.
Experimental: Extension Cohort A
IMA203 at RP2D
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.
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.
Experimental: Extension Cohort B
IMA203 at RP2D + nivolumab
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.
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.
Other Names:
  • Opdivo®
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of adverse events (AE)
[ Time Frame: up to 5 years post treatment ]

Secondary Outcome Measures:
1. Persistence of T-cells
[ Time Frame: up to 5 years post treatment ]

2. Tumor response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 and immune-related RECIST (irRECIST)
[ Time Frame: up to 12 months ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
  • 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.
  • For hepatocellular carcinoma (HCC) patients only, Child-Pugh score of ≤ 6
  • Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203
  • Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203
  • 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
  • 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 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 who have received more than 4 prior systemic treatment lines for treatment of advanced and/or metastatic disease.
  • Patients who are known to have at least one single tumor lesion that exceeds 10 cm in diameter
  • Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203 treatment
  • Patients with active brain metastases
  • Concurrent participation in an interventional part of 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

Open or close this module Contacts/Locations
Central Contact Person: Jorge Rivas, M.D., Ph.D.
Telephone: 346-204-5350
Email: ctgovinquiries@immatics.com
Study Officials: Cedrik Britten, M.D.
Study Director
Immatics US, Inc.
Locations: United States, New York
Columbia University Medical Center
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: 212-342-5162 cancerclinicaltrials@cumc.columbia.edu
Contact:Principal Investigator: Ran Reshef, MD
United States, Pennsylvania
University of Pittsburgh Medical Center
[Recruiting]
Pittsburgh, Pennsylvania, United States, 15232
Contact:Contact: Jason Luke, M.D. 412-623-6132 lukejj@upmc.edu
Contact:Principal Investigator: Jason Luke, M.D.
United States, Texas
University of Texas MD Anderson Cancer Center
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Dejka M Araujo, M.D. 713-792-3626 daraujo@mdanderson.org
Contact:Principal Investigator: Dejka M Araujo, M.D.
Germany
Universitätsklinikum Hamburg-Eppendorf
[Recruiting]
Hamburg, Germany, 20246
Contact:Contact: +49 (0)40 7410 - 52960 c.bokemeyer@uke.de
Contact:Contact: +49 (0)40 7410 - 53962
Contact:Principal Investigator: Carsten Bokemeyer, MD, PhD
Germany, Bavaria
Universitätsklinikum Regensburg, Franz-Josef-Strauß-Allee 11
[Not yet recruiting]
Regensburg, Bavaria, Germany, 93053
Contact:Contact: Daniel Heudobler, MD +49 (0)941 944-14800 daniel.heudobler@ukr.de
Contact:Principal Investigator: Daniel Heudobler, MD
Universitätsklinikum Würzburg
[Recruiting]
Würzburg, Bavaria, Germany, 97080
Contact:Contact: chatterjee_m@ukw.de
Contact:Contact: +49 (0)931 201 40953
Contact:Principal Investigator: Manik Chatterjee, MD
Germany, North Rhine-Westphalia
Universitätsklinikum Bonn - Medizinische Klinik III
[Recruiting]
Bonn, North Rhine-Westphalia, Germany, 53127
Contact:Contact: +49 (0)228 287-17233 tobias.holderried@ukbonn.de
Contact:Contact: +49 (0)151 44048451
Contact:Principal Investigator: Tobias Holderried, MD, PhD
Germany, Saxony
Universitätsklinikum C.-G.-Carus Dresden
[Recruiting]
Dresden, Saxony, Germany, 01307
Contact:Contact: +49 (0)351 458 7566 Martin.Wermke@uniklinikum-dresden.de
Contact:Principal Investigator: Martin Wermke, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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