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Trial record 1 of 1 for:    IMA202-101
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TCR-engineered T Cells in Solid Tumors: IMA202-101 (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.
 
ClinicalTrials.gov Identifier: NCT03441100
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Immatics US, Inc.

Brief Summary:
The study purpose is to establish the safety and tolerability of IMA202 product in patients with solid tumors that express melanoma-associated antigen 1 (MAGEA1).

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Cancer Hepatocellular Carcinoma Hepatocellular Cancer Nonsmall Cell Lung Cancer Liver Cancer Lung Cancer Drug: IMA202 Product Device: 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 IMA202 product.

MANUFACTURING: IMA202 product will be made from the patient's white blood cells.

TREATMENT: Lymphodepletion with cyclophosphamide and fludarabine will occur in the days before the IMA202 product infusion to improve the duration of time that IMA202 product stays in the body. The patient will be admitted to the hospital during the treatment.

After the IMA202 product 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 IMA202 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® IMA202-101)
Actual Study Start Date : May 2, 2019
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental: IMA202 Product
  • Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide
  • One dose of IMA202 product will be infused intravenously. Four dose levels will be evaluated. At least two patients per cohort will be treated.
  • Post-infusion of IMA202 product, administration of low dose recombinant human interleukin-2
Drug: IMA202 Product
Four dose levels (DL) of IMA202 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: 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. 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. 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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 IMA202 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
  • IMA202 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 IMA202
  • Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA202
  • Hepatocellular carcinoma (HCC) patients with liver cirrhosis only - upper endoscopy is required within 6 months of study entry
  • 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 ClinicalTrials.gov identifier (NCT number): NCT03441100


Contacts
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Contact: Jorge Rivas, M.D., Ph.D. 346-204-5350 ctgovinquiries@immatics.com

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact    212-342-5162    cancerclinicaltrials@cumc.columbia.edu   
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
Contact: Apostolia Tsimberidou, M.D.,Ph.D.         
Germany
Universitätsklinikum Würzburg Recruiting
Würzburg, Bavaria, Germany, 97080
Contact    +49 931 201 0      
Contact    +49 931 201 40953      
Principal Investigator: Manik Chatterjee, MD, PhD         
Universitätsklinikum Bonn - Medizinische Klinik III Recruiting
Bonn, North Rhine-Westphalia, Germany, 53127
Contact    +49 (0) 228 2870      
Contact    +49 228 287 17233      
Principal Investigator: Tobias Holderried, MD, PhD         
Universitätsklinikum C.-G.-Carus Dresden Recruiting
Dresden, Saxony, Germany, 01307
Contact    +49 351 458 7566      
Principal Investigator: Martin Wermke, MD, PhD         
Sponsors and Collaborators
Immatics US, Inc.
Investigators
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Study Director: Cedrik Britten, M.D. Immatics US, Inc.
Principal Investigator: Apostolia Tsimberidou, M.D., Ph.D. M.D. Anderson Cancer Center
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Responsible Party: Immatics US, Inc.
ClinicalTrials.gov Identifier: NCT03441100    
Other Study ID Numbers: IMA202-101
First Posted: February 22, 2018    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
Immunotherapy
Adoptive cellular therapy
T-Cell Receptor
Cell Therapy
Cytotherapy
IMA202
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Hepatocellular
Liver Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Digestive System Diseases
Liver Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms