Sample Collection for Cancer

Not currently recruiting at 20 trial locations

Overseen By Erica Gagnon

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: TScan Therapeutics, Inc.

Disqualifiers: Curative anticancer therapy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect samples from individuals with advanced or metastatic solid tumors, such as head and neck, cervical, and non-small cell lung cancer. The goal is to identify certain markers in the body, including tumor-associated antigens (special proteins found in cancer cells) and specific genetic traits. These tests help determine eligibility for future studies on new cell-based cancer therapies. Suitable candidates for this trial include those with one of these cancers who can provide a saliva sample and a small piece of tumor tissue. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive a potentially groundbreaking therapy.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that this sample collection method is safe?

Research has shown that autologous T cell therapy, which involves modifying a patient's own T cells, can help treat certain cancers. However, safety results are mixed. Some studies have identified serious side effects, such as T-cell cancers, which affect the immune cells themselves. These side effects are rare but serious.

On the positive side, some patients have experienced long-lasting benefits, with the modified T cells remaining active in their bodies for over two years. This indicates that the treatment can have a prolonged effect.

Similar therapies have received FDA approval for other cancers, suggesting some level of established safety and effectiveness. However, each treatment carries its own risks.

Overall, while autologous T cell therapy shows promise, it also presents potential risks. Prospective participants should weigh these risks against the possible benefits when considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to explore new biomarkers in patients with metastatic solid tumors, specifically focusing on Tumor-Associated Antigens (TAA), Human Leukocyte Antigen (HLA), and HLA Loss of Heterozygosity. Unlike traditional treatments that directly target tumors through chemotherapy, radiation, or surgery, this study seeks to understand the underlying genetic and molecular characteristics of tumors. By identifying these unique markers, the trial could pave the way for more personalized and effective treatments in the future, potentially improving outcomes for patients with these challenging conditions.

What evidence suggests that autologous T cell therapy could be effective for cancer?

Research has shown that autologous T cell therapy, a type of cancer treatment, holds promise for treating solid tumors. In some studies, 80% to 90% of patients experienced a lasting positive response, with their condition improving for an extended period. Another study found that 38.8% of patients saw their tumors shrink or remain stable. Patients who received this therapy with special preparations, such as reducing certain immune cells beforehand, had an improved response rate of 77%. These findings suggest that autologous T cell therapy could be an effective treatment option for certain types of cancer. ^{5 6 7 8 9}

Who Is on the Research Team?

Dawn Pinchasik, MD

Principal Investigator

TScan Therapeutics, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Willing and able to provide written informed consent.

Head and neck cancer

Cervical cancer

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 years

Multiple visits as needed for sample collection

Sample Collection

Participants provide buccal swab, saliva sample, and archival tissue for HLA and tumor antigen testing

Varies based on sample collection

1-2 visits (in-person)

Follow-up

Participants are monitored for eligibility and referred to interventional trials if eligible

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Autologous T Cell Therapy

Who Is Running the Clinical Trial?

TScan Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

1,400+

Citations

1. nature.com nature.com/articles/s41392-025-02269-w

CAR-T cell therapy for cancer: current challenges and ... Among those patients who received the recommended dose, the 3-year overall survival and event-free survival were 60% and 36%, respectively. The ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6511615/

Survival outcomes and efficacy of autologous CD19 ... Patients who received lymphodepletion was associated with a better response rate (77%, 95%CI: 67–83%; p-value =0.001) in comparison to the other patients who ...

3. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-473440

Autologous T-Cell Therapies in Solid Tumor Malignancies Treatment in these settings has resulted in durable response rates as high at 80%-90%. These findings have not been replicated in clinical ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666634025001047

Emerging trends in clinical allogeneic CAR cell therapy Recent clinical trials have demonstrated sustained and significant elimination of autoreactive B cells through autologous CD19- and/or BCMA- ...

5. onclive.com onclive.com/view/targeted-car-t-cell-therapies-show-early-efficacy-in-solid-tumors-with-focus-on-mitigating-toxicity

Targeted CAR T-Cell Therapies Show Early Efficacy in ... No dose-limiting toxicities (DLTs) or treatment-related deaths were reported, and the overall response rate (ORR) was 38.8% in patients treated ...

6. fda.gov fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-investigating-serious-risk-t-cell-malignancy-following-bcma-directed-or-cd19-directed-autologous

FDA Investigating Serious Risk of T-cell Malignancy FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received ...

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00039-X/abstract

the long-term safety of autologous chimeric antigen ... Engineering a patient's own T cells to express chimeric antigen receptors (CARs) has cured patients with cancer refractory to all treatments.

8. nature.com nature.com/articles/s41409-025-02691-2

Safety and efficacy of autologous humanized CD19 CAR-T ... One patient (Patient 3) demonstrated prolonged CAR-T cell persistence in vivo, with CAR-T cells still detectable in peripheral blood 31.4 months ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11305028/

Approved CAR-T therapies have reproducible efficacy and ... There are currently six commercial CAR-T products that have been FDA approved for diseases such as B-ALL, LBCL, MCL, FL, MM, and CLL/SLL.