ACTengine® IMA203/IMA203CD8 as Monotherapy or in Combination With Nivolumab in Recurrent and/or Refractory Solid Tumors

Part of paid clinical trials in Stanford, California.

Sponsor
Immatics US, Inc.
Study ID
NCT03686124
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cancer
  • Recurrent Cancer
  • Refractory Cancer
  • Solid Tumor, Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IMA203 Product — BIOLOGICAL
    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
  • IMA203 product- flat dose — BIOLOGICAL
    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells
  • IMA203CD8 Product — BIOLOGICAL
    The cell dose will be based on viable CD3+CD8+ HLA- Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula
  • Nivolumab — DRUG
    Nivolumab will be given post IMA203/IMA203CD8 infusion, after hematologic recovery is achieved. Clinical supply provided by Bristol Myers Squibb.
  • IMADetect® — DEVICE
    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.

Study Details

The study's purpose is to establish the safety and tolerability of IMA203/IMA203CD8 products with or without combination with nivolumab in patients with solid tumors that express preferentially expressed antigen in melanoma (PRAME).

Key Dates

Start date
May 14, 2019
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2032

Study Design

Enrollment
375 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation A (closed to enrollment)
    Dose escalation of IMA203
  • Experimental: Extension Cohort A
    IMA203 at RP2D
  • Experimental: Extension Cohort B (closed to enrollment)
    IMA203 at RP2D + nivolumab
  • Experimental: Extension Cohort AA
    IMA203 at final RP2D (flat dose)
  • Experimental: Uveal Melanoma
    IMA203 at RP2D
  • Experimental: Dose Escalation B
    Dose escalation of IMA203CD8
  • Experimental: Extension Cohort C
    IMA203CD8 at dose levels confirmed to be safe
  • Experimental: Extension Cohort D
    IMA203CD8 at dose levels confirmed to be safe; without IL-2
  • Experimental: Ovarian
    IMA203CD8 monotherapy at dose levels confirmed to be safe
  • Experimental: Endometrial
    IMA203CD8 monotherapy at dose levels confirmed to be safe
  • Experimental: Head and Neck, Lung, and Triple Negative Breast Cancer
    IMA203CD8 monotherapy at dose levels confirmed to be safe
  • Experimental: Rare Cancers
    IMA203CD8 monotherapy at dose levels confirmed to be safe

Primary Outcome Measure

Phase 1: Determine the MTD and/or recommended dose for extension for IMA203/IMA203CD8 [ Time Frame: 28 days ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Stanford Cancer InstituteStanfordCalifornia94305
Allison Warner, MD
[email protected]
University of Colorado, Anschutz Medical CampusAuroraColorado80045
Sapna Patel, MD
720-848-0000
University of Miami Hospital and ClinicsMiamiFlorida33136
[email protected]
305-243-2647
University of Chicago Medical CenterChicagoIllinois60637
Katherine Kurnit, MD
Massachusetts General HospitalBostonMassachusetts02114
Oldadapo O. Yeku, MD. PhD
617-643-6158
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alexander Shoushtari, MD
[email protected]
646-888-4161
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill RunColumbusOhio43026
Casey Cosgrove, MD
[email protected]
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Anthony Olszanski, MD, RPh
[email protected]
Anthony Olszanski, MD (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University, Honickman CenterPhiladelphiaPennsylvania19107
Rino Seedor, MD
[email protected]
215-847-7409
University of Pennsylvania, Perelamn Center for Advanced MedicinePhiladelphiaPennsylvania19104
Janos Tanyi, MD, PhD
[email protected]
University of Pittsburgh Medical CenterPittsburghPennsylvania15232
Diwakar Davar, M.D.
[email protected]
412-623-7368
Jason Luke, M.D. (PRINCIPAL_INVESTIGATOR)
University of Texas MD Anderson Cancer CenterHoustonTexas77030
Dejka M Araujo, M.D.
[email protected]
713-792-3626
Dejka M Araujo, M.D. (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Sylvia Lee, MD
[email protected]

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