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Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

“Anthony J. Olszanski, MD, RPh

Study Summary

Phase 1 Objectives

Primary

  • To evaluate safety and tolerability of treatment with ACTengine® IMA203/IMA203CD8 products as monotherapy or in combination with nivolumab
  • To determine the maximum tolerated dose (MTD) and/or recommended dose for extension (RP2D) for IMA203/IMA203CD8

Secondary

  • To evaluate persistence of TCR-engineered T cells after IMA203/IMA203CD8 monotherapy or in combination with nivolumab
  • To evaluate anti-tumor activity after IMA203/IMA203CD8 monotherapy or in combination with nivolumab

Exploratory

  • To evaluate anti-tumor activity after IMA203/IMA203CD8 monotherapy or in combination with nivolumab
  • To evaluate biomarkers potentially associated with safety, biological activity, efficacy, product characteristics, or prognosis
  • To evaluate the feasibility of the ACTengine® IMA203/IMA203CD8 manufacturing processes

Phase 2 Objectives

Primary

  • To evaluate safety and tolerability of treatment with ACTengine® IMA203 product as monotherapy
  • To evaluate the initial anti-tumor activity of IMA203

Secondary

  • To evaluate the initial anti-tumor activity of IMA203
  • To evaluate persistence of TCR-engineered T cells after monotherapy or in combination with nivolumab

Exploratory

  • To evaluate biomarkers potentially associated with safety, biological activity, efficacy, product characteristics, or prognosis
  • To evaluate the feasibility of the ACTengine® IMA203 manufacturing process

Contact Us
About This Trial:

For more information about this and other studies and to inquire about eligibility, please call 215-214-1515 or fill out this form.

Protocol: 23-1030

Phase: I/II

Investigator: Anthony Olszanski, MD, RPh

Disease(s): Breast, Corpus Uteri, Eye and Orbit, Larynx, Lip, Oral Cavity and Pharynx, Lung, Melanoma, Skin, Ovary, Soft Tissue

Full Title: Phase 1/2 Study Evaluating Genetically Modified Autologous T Cells Expressing a T-cell Receptor Recognizing a Cancer/germline Antigen as Monotherapy or in Combination With Nivolumab in Patients With Recurrent and/or Refractory Solid Tumors

ClinicalTrials.gov
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Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

Inclusion Criteria:

  • 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
  • HLA phenotype positive for the study
  • Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR
  • Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203/IMA203CD8
  • Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203/IMA203CD8
  • The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion