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Trial record 1 of 1 for:    IMA202
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TCR-engineered T Cells in Solid Tumors Including NSCLC and HCC Patients (ACTengine)

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ClinicalTrials.gov Identifier: NCT03441100
Recruitment Status : Recruiting
First Posted : February 21, 2018
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
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.

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.

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/Germline Antigen in Patients With Solid Tumors Including But Not Limited to NSCLC or HCC
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2033

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. Number of subjects with dose-limiting toxicity (DLT) and adverse events (AE) [ Time Frame: 6 months to 18 months ]

Secondary Outcome Measures :
  1. Assessment of tumor responses and progression based on RECIST 1.1 and immune-related RECIST (irRECIST). [ Time Frame: 12 and 24 weeks after the infusion of IMA202 product ]
  2. Success rate of IMA202 product generation [ Time Frame: 12 months ]
  3. Duration of infused IMA202 product over time [ Time Frame: 12 months ]
  4. Incidence of infused IMA202 product [ Time Frame: 12 months ]
  5. Blood based assessment to evaluate the mechanisms of action of IMA202 product [ Time Frame: 24 months ]
  6. Blood based assessment to evaluate the pharmacodynamics of IMA202 product [ Time Frame: 24 months ]
  7. Assessment of tumor biomarker expression levels [ Time Frame: 24 months ]
  8. Assessment of T-cell infiltration [ Time Frame: 24 months ]
  9. Rate of successful biomarker tests for tumor samples collected [ Time Frame: 24 months ]


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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:

  • Patients must have pathologically confirmed advanced/metastatic solid tumors including but not limited to one of the following indications. For patients with other solid tumors, there should be evidence of sufficient high likelihood of target expression e.g. as the prevalence in the given indication is high or as there is evidence for the individual patient from previous assessments that the tumor is target positive. These patients should have relapsed and/or refractory solid cancers with no established treatment available and they are terminally ill:
  • Pathologically confirmed diagnosis of stage IIIB/IV recurrent NSCLC OR Pathologically or radiologically (fulfilling non-invasive criteria) confirmed diagnosis of HCC not amenable to resection (partial hepatectomy or liver transplantation) or local therapy with curative intent (e.g. radiofrequency ablation)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Signed written informed consent form
  • Women of childbearing potential must use adequate contraception

MAIN SCREENING:

  • HLA phenotype positive. Note: Patients who were previously HLA-typed for participation in other Immatics' sponsored clinical trials and were HLA phenotype positive may enter IMA202-101 main screening
  • Patient's tumor must express specified biomarkers. Note: Patients who were previously screened for participation in other Immatics' sponsored clinical trials and whose biomarkers are positive for IMA202-101 based on IMA_Detect may enter IMA202-101 screening
  • Adequate organ and marrow function, defined per protocol
  • Measurable disease
  • At least one lesion (metastasis or primary tumor) being considered accessible for a biopsy
  • Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ≤6 and Model for End-Stage Liver Disease (MELD) score≤15
  • Serum creatinine within 1.5 x normal range for age OR creatinine clearance with a recommended eGFR ≥ 50 mL/min/1.73m^2
  • Adequate pulmonary function
  • Acceptable coagulation status
  • Availability of production capacities for the patient's IMA202 product prior to the leukapheresis

TREATMENT SCREENING:

These patients should have relapsed and/or refractory solid cancers with no established treatment available and they are terminally ill:

  • Available IMA202 product passed all required release tests
  • Adequate hepatic function for squamous cell NSCLC patients, as defined per protocol. For HCC patients: Child-Pugh score ≤6 and Model for End-Stage Liver Disease (MELD) score≤15
  • Serum creatinine within 1.5 x normal range for age OR creatinine clearance with a recommended eGFR ≥ 50 mL/min/1.73m^2
  • Measurable disease
  • Male patients must agree to use effective contraception or be abstinent while on study and for 90 days after the infusion of IMA202 product

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Serious autoimmune disease

HLA SCREENING:

• History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years

MAIN SCREENING:

  • Any condition contraindicating leukapheresis
  • 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
  • HIV infection, active hepatitis B or C infection. History of treated hepatitis B or C is permitted if the viral load is undetectable. HCC patients with controlled or chronic stable 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 HCV infections will be allowed for screening; however, subjects with both HBV and HCV infections will be excluded for screening
  • Patient has received any chemotherapy, surgery, radiotherapy (for therapeutic purposes), tyrosine kinase inhibitors, investigational drugs, chronic use of systemic corticosteroids or statin therapy within 2 weeks prior to the leukapheresis
  • Concomitant therapy indicated with any of the following: interferons or other non-study immunotherapy regimens; immunosuppressive agents; other investigational therapies; or chronic use of systemic corticosteroids
  • Severe immune-related toxicity related to checkpoint inhibitors defined as any Grade 4 toxicity or Grade 3 toxicity
  • Cardiac conditions per protocol
  • Prior stem cell transplantation or solid organ transplantation
  • Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
  • Active diverticulitis, intra-abdominal abscess or gastrointestinal (GI) obstruction
  • History of hypersensitivity to cyclophosphamide, fludarabine or IL-2
  • History of or current immunodeficiency disease or prior treatment compromising immune function
  • Patients with active pneumonitis

TREATMENT SCREENING:

  • Patient received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks, monoclonal antibodies or investigational drugs within 4 weeks or tyrosine kinase inhibitor within 1 week, or the patient has not recovered prior to lymphodepletion regimen. Note: Patient may be still eligible if the patient has not fully recovered from grade ≥2 toxicities if accumulated toxicities with the lymphodepletion therapy are not expected
  • Active pneumonitis
  • Patient unable to tolerate lymphodepletion, low-dose IL-2 and/or IMA202 product
  • Severe immune-related toxicity related to checkpoint inhibitors defined as any Grade 4 toxicity or Grade 3 toxicity

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
Contact: Rebecca Griffith-Eskew 346-204-5359 griffith-eskew@immatics.com

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Immatics US, Inc.
M.D. Anderson Cancer Center
Investigators
Study Director: Stephen Eck, M.D., Ph.D. Immatics US, Inc.

Responsible Party: Immatics US, Inc.
ClinicalTrials.gov Identifier: NCT03441100     History of Changes
Other Study ID Numbers: IMA202-101
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Immatics US, Inc.:
T-Cell therapy
Immunotherapy
Adoptive cellular therapy
T-Cell Receptor
Cell Therapy
Cytotherapy
IMA202

Additional relevant MeSH terms:
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