Solid Tumor, AdultNCT05230186
A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.
An observational study of Solid Tumor, Adult, run by TScan Therapeutics, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Tumor Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Feb 2021to 20 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Both men and women and members of all races and ethnic groups are eligible for this protocol. Patients with solid tumors who are responding to ICI therapy will be enrolled.
Who may be able to join
- Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo, Cohort 5: Post-Treatment Responder (Frozen)
- Study Cohorts 1,2,3 and 5: Known or suspected diagnosis of non-hematological malignancy.
- Age 18 years at time of diagnosis.
- Research Biopsy Study Cohorts 1 and 2: ECOG performance status 0-2.
- Ability to understand and willingness to sign an informed consent document.
- 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.
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- 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.
- 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.
- Research Biopsy Study Cohorts 1,2,4: Platelet count >50,000 prior to biopsy or per the service performing the biopsy.
- Research Biopsy Study Cohorts 1,2,4: Absolute neutrophil count >1500.
- Research Biopsy Study Cohorts 1,2,4: Must be able to safely hold anticoagulants for 5 days prior to biopsy.
- 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:
- No warfarin (Coumadin) for 5 days. No low-molecular weight heparin (LMWH; e.g. dalteparin/ Fragmin, enoxaparin/ Lovenox) for 24 hours.
- No fondaparinux/ Arixtra for 48 hours. iii. Patients receiving alternative forms of anticoagulation not listed above (e.g., dabigatran, rivaroxaban, apixaban, edoxaban) should consult with the prescribing physician and the service performing the biopsy regarding safety and administration guidelines prior to biopsy. Bleeding risks with these agents should be considered when deciding on whether to perform the biopsy if for research purposes only.
Who cannot join
- Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo, Cohort 5: Post-Treatment Responder (Frozen)
- 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.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Research Biopsy Study Cohorts 1,2,4: History of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
- 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.
- Research Biopsy Study Cohorts 1,2,4: Active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months. ii. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.
- Myocardial infarction < 6 months from study entry. iv. Uncontrolled or symptomatic congestive heart failure. f. Any other condition, which in the opinion of the patient's treating oncologist or the physician performing the biopsy procedure, would make participation in this protocol unreasonably hazardous for the patient.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
Atlantic Health System
Morristown, New Jersey, 07960
Ochsner Clinic Foundation
New Orleans, Louisiana, 70124
Advanced Oncology PC
New York, New York, 10013
About this study
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.
- Conditions
- Solid Tumor, Adult
- Being tested
- Tumor Biopsy
- Keywords
- Solid Tumor, Renal cell carcinoma, Bladder cancer, Melanoma, Triple negative breast cancer, Colon cancer, Lung cancer, Endometrial cancer
- Medical subject headings
- Carcinoma, Renal Cell, Urinary Bladder Neoplasms, Melanoma, Triple Negative Breast Neoplasms, Colonic Neoplasms, Lung Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor BiopsyProcedure or surgery
Also called Excess tissue during planned surgical procedure
Research biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample.
| Study group | Role | What they receive |
|---|---|---|
| On-Treatment Solid Tumor Responder (Tumor Biopsy) | 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. Receives: Procedure: Tumor Biopsy | |
| Pre and On-Treatment Solid Tumor Responder (Tumor Biopsy) | 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. Receives: Procedure: Tumor Biopsy | |
| On-Treatment Solid Tumor Responder (Surgical Removal Tumor) | 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. | |
| Post-Treatment of patients with Melanoma who develop vitiligo | 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 Receives: Procedure: Tumor Biopsy | |
| On-Treatment Responder (Previously Frozen Tumor Tissue) | Previously Cryopreserved Tissue obtained from a Biobank or Tissue Repository, collected from patients when they were responding to ICI Therapy (clinical data required). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Single Cell Sequencing
Determine, through single-cell sequencing, the TCR repertoire of these tumor and blood samples to identify new targets.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start26 Feb 2021
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- TScan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230186
- Sponsor's protocol ID
- 200-04
- Status last verified
- Apr 2024
- First submitted
- 27 Jan 2022
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Tissue Collection Study in Patients Who Respond to Immune Checkpoint Inhibitors to Identify Targets of Tumor-Reactive T Cells.
- ClinicalTrials.gov ID
- NCT05230186
- Acronym / sponsor ID
- 200-04
- Conditions
- Solid Tumor, Adult
- Keywords
- Solid Tumor, Renal cell carcinoma, Bladder cancer, Melanoma, Triple negative breast cancer, Colon cancer, Lung cancer, Endometrial cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TScan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| On-Treatment Solid Tumor Responder (Tumor Biopsy) | – | Procedure: Tumor BiopsyResearch tumor tissue biopsy collected at any one time point while responding to ICI therapy (radiographic regression of lesion). Tumor biopsy and companion blood sample. |
| Pre and On-Treatment Solid Tumor Responder (Tumor Biopsy) | – | Procedure: Tumor BiopsyTumor 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. |
| On-Treatment Solid Tumor Responder (Surgical Removal Tumor) | – | –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. |
| Post-Treatment of patients with Melanoma who develop vitiligo | – | Procedure: Tumor BiopsyUp 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 |
| On-Treatment Responder (Previously Frozen Tumor Tissue) | – | –Previously Cryopreserved Tissue obtained from a Biobank or Tissue Repository, collected from patients when they were responding to ICI Therapy (clinical data required). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Both men and women and members of all races and ethnic groups are eligible for this protocol. Patients with solid tumors who are responding to ICI therapy will be enrolled.
Key inclusion criteria (14 listed)
- Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo, Cohort 5: Post-Treatment Responder (Frozen)
- Study Cohorts 1,2,3 and 5: Known or suspected diagnosis of non-hematological malignancy.
- Age 18 years at time of diagnosis.
- Research Biopsy Study Cohorts 1 and 2: ECOG performance status 0-2.
- Ability to understand and willingness to sign an informed consent document.
Key exclusion criteria (8 listed)
- Cohort Legend: Cohort 1: On-Treatment Responder (Biopsy), Cohort 2: Pre and On-Treatment (Biopsy), Cohort 3: On-Treatment Responder (Surgery), Cohort 4: Post-Treatment Vitiligo, Cohort 5: Post-Treatment Responder (Frozen)
- 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.
- Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
- Research Biopsy Study Cohorts 1,2,4: History of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tumor BiopsyAlso: Excess tissue during planned surgical procedureResearch biopsy of solid tumor or sharing of excess tumor tissue during a planned surgical or biopsy procedure and a companion blood sample. | Procedure or surgery | On-Treatment Solid Tumor Responder (Tumor Biopsy), Post-Treatment of patients with Melanoma who develop vitiligo, Pre and On-Treatment Solid Tumor Responder (Tumor Biopsy) |
Primary outcome
Single Cell Sequencing
Time frame: 3 years
Determine, through single-cell sequencing, the TCR repertoire of these tumor and blood samples to identify new targets.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Solid Tumor, Adult, run by TScan Therapeutics, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single Cell Sequencing (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.