NCT02876510

ACTolog in Patients With Solid Cancers

Phase I Adoptive Cellular Therapy Trial With Endogenous CD8+ T Cells (ACTolog® IMA101) Alone or in Combination With Atezolizumab in Patients With Relapsed and/or Refractory Solid Cancers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Immatics US, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

SCREENING: Patient eligibility will be determined by HLA (human leukocyte antigen) and the main biomarkers screening. If the patient is eligible, white blood cells will be collected with a leukapheresis for the manufacture of the IMA101 product. MANUFACTURE: IMA101 product will be made from the patient's white blood cells. TREATMENT: IMA101 product will be administered to the patient intravenously after lymphodepleting pre-conditioning with chemotherapy (fludarabine and cyclophosphamide). Low-dose IL-2 will be self-administered twice daily for a total of 28 doses after infusion of IMA101 product. In Cohort 2, atezolizumab will be administered every 3 weeks, starting no earlier than 3 weeks after the IMA101 product infusion and after hematologic recovery. Patients will be monitored closely throughout the study.

Conditions

• Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine infusion
DRUG	Cyclophosphamide	Cyclophosphamide infusion
BIOLOGICAL	IMA101 product	i.v. infusion of IMA101 product(s).
BIOLOGICAL	Recombinant human interleukin-2	Low dose IL-2 Infusion for two weeks
DIAGNOSTIC_TEST	IMADetect	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.
DRUG	Atezolizumab	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.

Timeline

• Start date: 2017-06-30
• Primary completion: 2021-09-22
• Completion: 2021-09-22
• First posted: 2016-08-23
• Last updated: 2025-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study