ACTolog in Patients With Solid Cancers

Part of paid clinical trials in Houston, Texas.

Sponsor
Immatics US, Inc.
Study ID
NCT02876510
Phase
PHASE1
Status
Completed

Conditions

  • Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Fludarabine infusion
  • Cyclophosphamide — DRUG
    Cyclophosphamide infusion
  • IMA101 product — BIOLOGICAL
    i.v. infusion of IMA101 product(s).
  • Recombinant human interleukin-2 — BIOLOGICAL
    Low dose IL-2 Infusion for two weeks
  • IMADetect — DIAGNOSTIC_TEST
    IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.
  • Atezolizumab — DRUG
    Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.

Study Details

The study purpose is to learn about the safety and tolerability of IMA101 alone (Cohort 1) or in combination with atezolizumab (Cohort 2) in patients with advanced solid cancers that express pre-defined Immatics tumor targets.

Key Dates

Start date
Jun 30, 2017
Status verified
Feb 2025
Primary completion
Sep 22, 2021
Completion
Sep 22, 2021

Study Design

Enrollment
38 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMA101 product only (Cohort 1)
    * Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * Infusion of the IMA101 T-cell product(s) * Post-infusion administration of low-dose recombinant human interleukin-2
  • Experimental: IMA101 product + atezolizumab (Cohort 2)
    * Pre-conditioning by non-myeloablative chemotherapy with Fludarabine and Cyclophosphamide * Infusion of the IMA101 T-cell product(s) * Post-infusion administration of low-dose recombinant human interleukin-2 * Treatment with atezolizumab every 3 weeks after IMA101 product infusion, for 1 year

Primary Outcome Measure

Incidence of adverse events (Safety and tolerability) of IMA101 alone or in combination with atezolizumab [ Time Frame: up to 18 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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