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History of Changes for Study: NCT03686124
TCR-engineered T Cells in 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:  March 14, 2019 (v3)

Open or close this module Study Identification
Unique Protocol ID: IMA203-101
Brief Title: TCR-engineered T Cells in Solid Tumors (ACTengine)
Official Title: Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Relapsed and/or Refractory Solid Tumors (ACTengine IMA203-101)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2019
Overall Status: Not yet recruiting
Study Start: March 2019
Primary Completion: January 2021 [Anticipated]
Study Completion: January 2035 [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:
March 14, 2019
Last Update Posted: March 18, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Immatics US, Inc.
Responsible Party: Sponsor
Collaborators: M.D. Anderson Cancer Center
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 in patients with solid tumors.
Detailed Description:

SCREENING: Patient eligibility will be determined by 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 treatment.

After the IMA203 product infusion, a low dose of IL-2 will be given subcutaneously twice daily for 14 days.

Since this study involves gene therapy, patients will be monitored throughout the study and for up to a total of 15 years.

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: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 16 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: IMA203 Product
  • Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
  • One dose of IMA203 product will be infused intravenously. Four dose levels will be evaluated. At least two patients per cohort will be treated.
  • Post-infusion of IMA203 product, administration of low dose recombinant human interleukin-2
Biological: IMA203 Product
Four dose levels (DL) of IMA203 product will be evaluated. 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Number of subjects with dose-limiting toxicity (DLT)
[ Time Frame: 3 weeks ]

2. Number of treatment-emergent adverse events
[ Time Frame: up to 12 months ]

3. Number of treatment-emergent adverse events of special interest
[ Time Frame: up to 12 months ]

4. Number of treatment-emergent serious adverse events
[ Time Frame: up to 12 months ]

5. Recommended Phase 2 Dose (RP2D)
[ Time Frame: end of accrual, approximately 12 months ]

Secondary Outcome Measures:
1. Frequency of TCR engineered T cells within blood T cells
[ Time Frame: Up to 12 months ]

2. Duration of tumor response
[ 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:

  • 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
  • Measurable disease
  • Adequate pulmonary function per protocol
  • Acceptable organ and bone marrow function per protocol
  • Acceptable coagulation status per protocol
  • Adequate hepatic function per protocol
  • Serum creatinine within normal range for age OR creatinine clearance with a recommended estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2
  • Patient's tumor must express tumor antigen by qPCR using a tumor biopsy specimen OR be a tumor type with at least 95% known prevalence of protocol-specific antigen expression
  • Life expectancy more than 3 months
  • Confirmed availability of production capacities for IMA203 product
  • 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 and model for end-stage liver disease (MELD) score ≤ 15
  • IMA203 product must have passed all of the release tests
  • Female patient of childbearing potential must use adequate contraception prior to study entry until 6 months after the infusion of IMA203
  • Male patient must agree to use effective contraception or be abstinent while on study and for 90 days after the infusion of IMA203

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 hypersensitivity to cyclophosphamide (CY), fludarabine (FLU), or IL-2
  • History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
  • HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C is permitted if the viral load is undetectable per qPCR and or nucleic acid testing.

Note: HCC patients with controlled hepatitis B virus (HBV) infection as defined by subjects with resolved (anti-surface antigen [HBs-Ag] antibody negative, anti-core antigen [HBc Ag] antibody positive) or chronic stable (anti HBs-Ag antibody positive HBV) HBV infection will be eligible for screening. HCC patients with HBV infections who are not on anti-HBV treatment will be excluded from the study. HCC subjects with hepatitis C virus (HCV) infections will be allowed for screening; however, subjects with both HBV and HCV infections will be excluded for screening.

  • Any condition contraindicating leukapheresis
  • Patients with active brain metastases

NOTE: Patients with a history of brain metastases may be eligible, if an imaging scan with contrast enhancement not older than 4 weeks is able to exclude the existence of currently active brain metastasis.

  • Treatment with protocol-defined excluded treatments, medical devices, and/or procedures per protocol
  • The patient has not recovered from any grade 2 or greater side effect of prior therapy to grade 2 or lower (except for non-clinically significant toxicities, e.g., alopecia, vitiligo) prior to lymphodepletion.
Open or close this module Contacts/Locations
Central Contact Person: Rebecca Griffith-Eskew
Telephone: 346-204-5359
Email: griffith-eskew@immatics.com
Study Officials: Apostolia Tsimberidou, M.D., Ph.D.
Principal Investigator
MDACC, Houston, TX
Locations: United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Contact:Contact: Apostolia Tsimberidou, M.D., Ph.D.
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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