RECRUITING

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

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Conditions

Refractory CancerRecurrent CancerSolid Tumor, AdultCancerT-cell therapyimmunotherapyMelanoma (Skin)Melanoma, UvealOvarian CarcinomaUterine CarcinomaUterine CarcinosarcomaImmatics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2019-05-14
Study Completion:2032-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03686124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  3. * HLA-A\*02:01 positive
  4. * For patients with ovarian/fallopian tube cancer only: Patients must have confirmed diagnosis of high-grade serous or endometrioid epithelial ovarian cancer (EOC), primary peritoneal cancer, or fallopian tube cancer.
  5. * For patients with endometrial carcinoma only: Patients must have a histologically confirmed diagnosis of recurrent or persistent endometrial carcinoma.
  6. * Measurable disease according to RECIST 1.1
  7. * Adequate selected organ function per protocol
  8. * Patient's tumor must express tumor antigen by "IMADetect® RT-qPCR. Retrospective testing will be required for patients that qualify.
  9. * Life expectancy more than 5 months
  10. * Female patient of childbearing potential must use adequate contraception prior to study entry until 12 months after the infusion of IMA203/IMA203CD8
  11. * Male patient must agree to use effective contraception or be abstinent while on study and for 6 months after the infusion of IMA203/IMA203CD8
  12. * The patient must have recovered from any side effects of prior therapy to Grade 1 or lower prior to lymphodepletion.
  1. * History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) within the last 3 years
  2. * Pregnant or breastfeeding
  3. * 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.
  4. * History of cardiac conditions as per protocol
  5. * Prior stem cell transplantation or solid organ transplantation
  6. * Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study
  7. * History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
  8. * Positive for HIV infection or with active hepatitis B virus (HBV) or active hepatitis C virus (HCV) infection.
  9. * Patients with LDH greater than 2.0-fold ULN.
  10. * Any condition contraindicating leukapheresis, lymphodepletion, low-dose IL-2, and/or IMA203/IMA203CD8 treatment
  11. * Patients with active brain metastases
  12. * Concurrent treatment in another clinical trial.
  13. * For nivolumab treatment, patients must not have a history of severe immune-related toxicities, defined as any Grade 3 or 4 toxicities related to prior PD1/PD-L1 inhibitor therapy (e.g., atezolizumab, pembrolizumab or nivolumab etc.).

Contacts and Locations

Study Contact

Immatics US, Inc.
CONTACT
+1 346 204-5400
ctgovinquiries@immatics.com

Principal Investigator

Cedrik Britten, M.D.
STUDY_DIRECTOR
Immatics US, Inc.

Study Locations (Sites)

University of Miami Hospital and Clinics
Miami, Florida, 33136
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Ohio State University Wexner Medical Center Gynecologic Oncology at Mill Run
Columbus, Ohio, 43026
United States
University of Pennsylvania, Perelamn Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Immatics US, Inc.

  • Cedrik Britten, M.D., STUDY_DIRECTOR, Immatics US, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-05-14
Study Completion Date2032-06

Study Record Updates

Study Start Date2019-05-14
Study Completion Date2032-06

Terms related to this study

Keywords Provided by Researchers

  • T-cell therapy
  • immunotherapy
  • Melanoma (Skin)
  • Melanoma, Uveal
  • Ovarian Carcinoma
  • Uterine Carcinoma
  • Uterine Carcinosarcoma
  • Immatics

Additional Relevant MeSH Terms

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