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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03247309
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : September 7, 2020
Information provided by (Responsible Party):
Immatics US, Inc.

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 or 8 (MAGEA4/8.

Condition or disease Intervention/treatment Phase
Solid Tumor Cancer Head and Neck Squamous Cell Carcinoma Non-small Cell Lung Cancer Biological: IMA201 Product Diagnostic Test: IMA_Detect Phase 1

Detailed Description:

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.

Patients will be closely monitored for safety and for a total of 3 years post IMA201 infusion.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Recurrent and/or Refractory Solid Tumors (ACTengine® IMA201-101)
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IMA201 Product
  • Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
  • One dose of IMA201 product will be infused intravenously. 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
The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.

Diagnostic Test: IMA_Detect
IMA_Detect 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. IMA_Detect is intended for investigational use only.

Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: up to 3 years post-treatment ]

Secondary Outcome Measures :
  1. Duration of infused T cells over time (Persistence of T cells) [ Time Frame: up to 3 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 and accessible to biopsy
  • 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 ≥ 50 mL/min/1.73 m2
  • 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
  • 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
  • IMA201 product must have passed all of the release tests
  • Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA201
  • Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA201
  • The patient must have recovered from any side effects of prior therapy to Grade 1 or lower (except for non-clinically significant toxicities; e.g., alopecia, vitiligo) prior to lymphodepletion. As determined by the investigator, the patient may still be eligible if the patient has not fully recovered from Grade ≥ 2 toxicities if these toxicities are not anticipated to further improve (e.g., chronic neuropathy) and such toxicities are not anticipated to worsen with the lymphodepletion therapy

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 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

    1. 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.
    2. 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
  • Patients with any active viral infection
  • 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, and steroid therapy has been discontinued for ≥2 weeks.

• Treatment with protocol-defined excluded treatments, medical devices, and/or procedures per protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03247309

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Contact: Jorge Rivas, M.D., Ph.D. 346-204-5350

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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-342-5162   
Principal Investigator: Ran Reshef, MD         
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Jason Luke, M.D.         
Principal Investigator: Jason Luke, M.D.         
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Immatics US, Inc.
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Study Director: Cedrik Britten, M.D. Immatics, US
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Immatics US, Inc. Identifier: NCT03247309    
Other Study ID Numbers: IMA201-101
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Immatics US, Inc.:
T-cell therapy
adoptive cellular therapy
T-Cell Receptor
Cell Therapy
Gene Therapy
Additional relevant MeSH terms:
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Squamous Cell Carcinoma of Head and Neck
Neoplasms by Site
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms