RECRUITING

A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.

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

T Cell Receptor-engineered T-cell therapy (TCR T-cell therapy) offers a potentially transformative approach to treating cancer, but is currently limited by the lack of known targets (Maus and June, 2016; Ping et al., 2018). Arguably the most clinically meaningful way to discover new targets and TCRs for TCR T-cell therapy is to study the tumor-infiltrating lymphocytes of patients that are actively responding to immune checkpoint inhibitor (ICI) therapy. These T cells are clonally expanded as a result of checkpoint inhibition and are responsible for the patient's clinical response. The goal of this study is to acquire tumor and blood samples from up to 200 patients with solid tumor malignancies who respond to ICI therapy. T cells will be isolated from these samples and the targets of their TCRs determined using TScan's genome-wide, high-throughput target ID technology. The expected outcome of this study is the discovery of a collection of new targets for TCR T-cell therapy, along with associated TCRs that will then be developed as novel therapies for patients with similar malignancies.

Official Title

A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.

Quick Facts

Study Start:2021-02-26
Study Completion:2024-12-23
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05230186

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. 1. Study Cohorts 1,2,3 and 5: Known or suspected diagnosis of non-hematological malignancy.
  2. 2. Age 18 years at time of diagnosis.
  3. 3. Research Biopsy Study Cohorts 1 and 2: ECOG performance status 0-2.
  4. 4. Ability to understand and willingness to sign an informed consent document.
  5. 5. Research Biopsy Study Cohorts 1,2,3 and 5: Patients must be eligible for or currently receiving treatment with immune checkpoint inhibitor (ICI) therapy as determined by the patient's treating oncologist. The treatment regimen may comprise more than one agent but must include at least one ICI drug. Examples of FDA-approved ICI drugs include pembrolizumab (Keytruda), nivolumab (Opdivo), atezolizumab (Tecentriq), avelumab (Bavencio), durvalumab (Imfinzi), cemiplimab (Libtayo), and ipilimumab (Yervoy). Immune-checkpoint inhibitors not on this list may also be used, provided they are FDA-approved.
  6. 6. Research Biopsy Study Cohorts 1,2,3 and 5: Patients undergoing an on-treatment biopsy must show radiographic regression of one or more lesion, as assessed by the investigator.
  7. 7. Research Biopsy Study Cohorts 1 and 2: Patients undergoing an on-treatment biopsy must have a cancer lesion that is amenable for biopsy under local anesthesia or moderate sedation per standard procedures. The tumor biopsy must have an acceptable clinical risk, as judged by the investigator.
  8. 8. Research Biopsy Study Cohorts 1,2,4: Platelet count \>50,000 prior to biopsy or per the service performing the biopsy.
  9. 9. Research Biopsy Study Cohorts 1,2,4: Absolute neutrophil count \>1500.
  10. 10. Research Biopsy Study Cohorts 1,2,4: Must be able to safely hold anticoagulants for 5 days prior to biopsy.
  11. 11. Research Biopsy Study Cohorts 1,2,4: Not receiving therapeutic anticoagulation at the time of the biopsy. Patients on therapeutic anticoagulation must be able to safely hold anticoagulation for the procedure with an acceptable risk, as judged by the investigator. Patients who are on anticoagulation for clinical reasons and deemed appropriate for biopsy must be OFF anticoagulation prior to biopsy as follows:
  1. 1. Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with safety.
  2. 2. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  3. 3. Research Biopsy Study Cohorts 1,2,4: History of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
  4. 4. Pregnant women are excluded because there may be an increased risk to both mother and fetus in the setting of moderate sedation, which is required for biopsies of certain anatomic sites (e.g., liver, lung, bone). Also, ionizing radiation from CT-guided biopsies may pose a risk to the unborn fetus.
  5. 5. Research Biopsy Study Cohorts 1,2,4: Active cardiac disease, defined as:

Contacts and Locations

Study Contact

Laurie Barefoot, APRN
CONTACT
857-399-9930
Lbarefoot@tscan.com
Shrikanta Chattopadhyay, MD
CONTACT
857-399-9472
Schattopadhyay@tscan.com

Study Locations (Sites)

USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124
United States
Atlantic Health System
Morristown, New Jersey, 07960
United States
Advanced Oncology PC
New York, New York, 10013
United States

Collaborators and Investigators

Sponsor: TScan Therapeutics, 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 Date2021-02-26
Study Completion Date2024-12-23

Study Record Updates

Study Start Date2021-02-26
Study Completion Date2024-12-23

Terms related to this study

Keywords Provided by Researchers

  • Solid Tumor
  • Renal cell carcinoma
  • Bladder cancer
  • Melanoma
  • Triple negative breast cancer
  • Colon cancer
  • Lung cancer
  • Endometrial cancer

Additional Relevant MeSH Terms

  • Solid Tumor, Adult