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CAR T-cell Therapy

On-Treatment Solid Tumor Responder (Tumor Biopsy) for Solid Tumors

N/A
Recruiting
Research Sponsored by TScan Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights

Summary

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.

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Single Cell Sequencing

Trial Design

5Treatment groups
Experimental Treatment
Group I: Pre and On-Treatment Solid Tumor Responder (Tumor Biopsy)Experimental Treatment1 Intervention
Tumor tissue collection prior to beginning ICI therapy (optional biopsy). If and when there is a response to ICI therapy, a second research tumor tissue biopsy is collected. Tumor biopsy and companion blood sample.
Group II: Post-Treatment of patients with Melanoma who develop vitiligoExperimental Treatment1 Intervention
Up to 5 patients treated for melanoma that develop vitiligo - Skin Tissue Biopsy obtained at any point in time from any skin site with vitiligo (selected sites only). Tissue biopsy
Group III: On-Treatment Solid Tumor Responder (Tumor Biopsy)Experimental Treatment1 Intervention
Research tumor tissue biopsy collected at any one time point while responding to ICI therapy (radiographic regression of lesion). Tumor biopsy and companion blood sample.
Group IV: On-Treatment Solid Tumor Responder (Surgical Removal Tumor)Experimental Treatment0 Interventions
Collection of excess tumor tissue in patients who are responding to ICI therapy and are scheduled for Surgical resection of residual disease. Excess tissue provided.
Group V: On-Treatment Responder (Previously Frozen Tumor Tissue)Experimental Treatment0 Interventions
Previously Cryopreserved Tissue obtained from a Biobank or Tissue Repository, collected from patients when they were responding to ICI Therapy (clinical data required).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tumor Biopsy
2006
Completed Phase 2
~370

Find a Location

Who is running the clinical trial?

TScan Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
893 Total Patients Enrolled
~13 spots leftby Dec 2024