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TCR-engineered T Cells in Solid Tumors With Emphasis on NSCLC and HNSCC (ACTengine) (ACTengine)

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ClinicalTrials.gov Identifier: NCT03247309
Recruitment Status : Recruiting
First Posted : August 11, 2017
Last Update Posted : July 9, 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 IMA201 in patients with solid tumors.

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 Diagnostic Test: ACT-HLA 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.

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 Having Solid Tumors With Emphasis on NSCLC or HNSCC
Actual Study Start Date : September 26, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2033

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.

Diagnostic Test: ACT-HLA
An assay used to determine whether a patient is positive for the allele HLA-A*02:01 or not, and thus is eligible for treatment with an ACTengine adoptive T-cell product.




Primary Outcome Measures :
  1. Incidence of adverse events (AE) [ Time Frame: up to 15 years post-treatment ]
    During treatment and treatment observation phases and long term gene safety follow up, AE and SAE will be captured per CTCAE v4.0. AEs and SAEs will be summarized.


Secondary Outcome Measures :
  1. Duration of infused T cells over time (Persistence of T cells) [ Time Frame: Up to 12 months ]
    Blood samples will be collected at selected time points (pre- and post-IMA201 treatment at set time points) to assess the persistence of IMA201 T-cells in the blood.

  2. Incidence of infused T cells (Functionality of T cells) [ Time Frame: Up to 12 months ]
  3. Success Rates of T cell generation (Feasibility of ACTengine approach) [ Time Frame: This endpoint can be evaluated after production of the last patient's specific T-cell product, i.e. after release of the last patient's cell product. Approximately 10 months ]
  4. Number of subjects with Clinical response [ Time Frame: 12 weeks and 24 weeks post IMA201 infusion ]
  5. Levels of Blood biomarkers [ Time Frame: until the end of the trial, up to 15 years from last patient treatment ]
  6. Levels of Tumor biomarkers [ Time Frame: until the end of the trial, up to 15 years from last patient treatment ]
  7. Rate of successful biomarker tests for tumor samples collected [ Time Frame: This can be evaluated after last patient's enrollment, approximately 12 months ]
  8. Percentages of patients expressing individual targets [ Time Frame: This can be evaluated after last patient's enrollment, approximately 10 months after start of trial. ]
  9. Concordance of HLA-A*02:01 Determination assay [ Time Frame: This can be evaluated after last patient's enrollment, approximately 10 months after start of trial. ]

Other Outcome Measures:
  1. Overall Survival (OS) will be assessed. [ Time Frame: until the end of the trial, up to 15 years from last patient treatment. ]
  2. Progression Free Survival (PFS) will be assessed. [ Time Frame: until the end of the trial, up to 15 years from last patient treatment. ]


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
Criteria

Inclusion Criteria:

  • Signed a written informed consent form(s).
  • ECOG performance status 0-1.
  • Women of childbearing potential must use adequate contraception (hormonal or barrier method of birth control; abstinence).

HLA INCLUSION

• Pathologically confirmed advanced/metastatic solid tumors such as one of the following indications:

  • Pathologically confirmed diagnosis of stage IIIB/IV recurrent NSCLC
  • Pathologically confirmed diagnosis of stage III/IV recurrent or metastatic HNSCC (oral cavity, pharynx, larynx)

MAIN SCREENING & LEUKAPHERESIS INCLUSION

  • Pathologically confirmed advanced/metastatic solid tumors such as one of the following indications:

    • Pathologically confirmed diagnosis of stage IIIB/IV recurrent NSCLC
    • Pathologically confirmed diagnosis of stage III/IV recurrent or metastatic HNSCC (oral cavity, pharynx, larynx)
  • 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 IMA201-101 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 IMA201-101 based on IMA_Detect may enter IMA201-101 screening
  • Recommended acceptable 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, as defined per protocol
  • Serum creatinine within 1.5 x normal range for age OR creatinine clearance with a recommended GFR ≥ 50 mL/min/1.73m2.
  • Adequate pulmonary function, defined per protocol and oxygen saturation >92% on room air.
  • Acceptable coagulation status: INR ≤2.0 x ULN and PTT ≤2.0 x ULN.
  • Confirmed availability of production capacities for the patient's ACTengine IMA201 product prior to the leukapheresis.

TREATMENT INCLUSION:

Patients may enter the treatment phase if:

  • Disease recurs/progresses
  • Disease becomes refractory or previous anti-cancer treatment is no longer warranted

    • Available IMA201 T-cell product that was produced for the patient and passed all release tests.
    • Adequate hepatic function per protocol.
    • Serum creatinine within 1.5 x normal range for age or creatinine clearance with a recommended GFR ≥ 50 mL/min/1.73m2.
    • Measurable disease
    • Male patients must agree to use effective contraception or be abstinent while on study and for 90 days after the infusion of IMA201.

Exclusion Criteria:

• Pregnant or is breastfeeding.

HLA EXCLUSION:

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

MAIN SCREENING EXCLUSION:

  • Any condition contraindicating leukapheresis.
  • Brain metastases.
  • HIV infection, active Hepatitis B or C infection
  • 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 toxicities related to checkpoint inhibitors defined per protocol.
  • 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 other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years.
  • Serious autoimmune disease
  • 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.
  • Investigator's judgment

TREATMENT EXCLUSION

  • Received chemotherapy, surgery, or radiotherapy (for therapeutic purposes) within 3 weeks (4 weeks for monoclonal antibodies or investigational drugs, 1 week for tyrosine kinase inhibitor (TKI) (e.g. erlotinib, gefitinib) or the patient has not recovered (from grade ≥2 side effects of the previous therapy) prior to lymphodepletion regimen.
  • Active pneumonitis.
  • Patient unable to tolerate lymphodepletion, low-dose IL-2 and/or ACTengine IMA201 treatment.
  • Severe immune-related toxicities related to checkpoint inhibitors defined per protocol.
  • Investigator's judgment

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): NCT03247309


Contacts
Contact: Rebecca Griffith-Eskew 3462045359 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: Hong Ma, M.D. Immatics US, Inc.

Responsible Party: Immatics US, Inc.
ClinicalTrials.gov Identifier: NCT03247309     History of Changes
Other Study ID Numbers: IMA201-101
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: July 9, 2018
Last Verified: July 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
IMA201
Cytotherapy
Cell Therapy
Gene Therapy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell