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Trial record 1 of 1 for:    IMA203
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TCR-engineered T Cells in Solid Tumors (ACTengine)

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ClinicalTrials.gov Identifier: NCT03686124
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : April 29, 2019
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 IMA203 product in patients with solid tumors.

Condition or disease Intervention/treatment Phase
Refractory Cancer Recurrent Cancer Solid Tumor, Adult Cancer Biological: IMA203 Product Device: IMADetect Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
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 Relapsed and/or Refractory Solid Tumors (ACTengine IMA203-101)
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2035

Arm Intervention/treatment
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.




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 ]


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:

  • 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.

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): NCT03686124


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

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Apostolia Tsimberidou, M.D., Ph.D.         
Sponsors and Collaborators
Immatics US, Inc.
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Apostolia Tsimberidou, M.D., Ph.D. MDACC, Houston, TX

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Responsible Party: Immatics US, Inc.
ClinicalTrials.gov Identifier: NCT03686124     History of Changes
Other Study ID Numbers: IMA203-101
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019

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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
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Immatics US, Inc.:
T-cell therapy
immunotherapy

Additional relevant MeSH terms:
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Recurrence
Disease Attributes
Pathologic Processes