What side effects are associated with this type of intervention?

Common treatments for melanoma, particularly immunotherapies like immune checkpoint inhibitors and engineered T cell therapies, can cause a range of immune-related side effects. These include inflammation in various organs, leading to conditions such as colitis, hepatitis, pneumonitis, and endocrinopathies. Skin toxicities like rash and pruritus are also common. Severe adverse events may necessitate immunosuppressive treatment. Specific drugs like ipilimumab (CTLA-4 inhibitor) and PD-1 inhibitors can cause fatigue, diarrhea, and endocrine dysfunctions.

What prior FDA approvals exist?

FDA-approved treatments for melanoma that involve engineered T cells or similar immunotherapies include chimeric antigen receptor (CAR) T-cell therapies and immune checkpoint inhibitors. Notable examples are pembrolizumab and nivolumab, which are PD-1 inhibitors, and ipilimumab, a CTLA-4 inhibitor. These therapies enhance the immune system's ability to target and destroy cancer cells. While specific TCR-T cell therapies targeting cancer-associated antigens via T cell receptors are still under investigation, these approved treatments share the common goal of leveraging the immune system to combat melanoma.

What other types of research exist?

Promising novel alternatives to TCR-T cell therapies for melanoma patients include: 1) Immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. 2) Combination therapies like talimogene laherparepvec (T-VEC) plus pembrolizumab, which have shown efficacy in advanced melanoma. 3) Targeted therapies for specific mutations, such as BRAF inhibitors (e.g., dabrafenib, trametinib) for BRAF V600-mutant melanoma. These alternatives offer different mechanisms of action and have demonstrated promising results in clinical settings.

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CAR T-cell Therapy

Customized TCR-T Cell Therapy for Cancer

Phase 1

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 up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new cancer treatment where a patient's immune cells are modified to better fight their cancer. It focuses on patients with advanced solid tumors who have specific genetic markers. The modified cells are designed to recognize and attack cancer cells more effectively.

Who is the study for?

This trial is for adults with advanced solid tumors that can't be surgically removed or have spread, and who've tried all other treatments without success. They must match specific genetic markers (HLA types) and their cancer should express certain proteins (MAGE-A1/HPV16-E7). Good physical condition is required, they must understand the study, and not be on high-dose steroids or have serious heart issues.

What is being tested?

The study tests personalized T cell therapies where patients' own immune cells are engineered to target cancer. It's an open-label trial meaning everyone knows what treatment they're getting. Participants will receive one of several therapy combinations after chemotherapy intended to prepare their body for the new cells.

What are the potential side effects?

Potential side effects include reactions from the infused cells, such as fever or fatigue; complications from the lymphodepleting chemotherapy like nausea; organ inflammation; increased risk of infection due to weakened immune defenses; and possible allergic reactions to components in the therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the recommended phase 2 dose of monotherapy and T- Plex combination TCR-Ts

Evaluate the safety of monotherapy and T- Plex combination TCR-Ts

Secondary study objectives

Investigate preliminary anti-tumor activity of monotherapy and T- Plex combination TCR-Ts

Investigate the feasibility of repeat dosing of monotherapy and T- Plex combination TCR-Ts

Other study objectives

To measure the immune activation markers in the tumor after single and repeated doses

To measure the infiltration of T-Plex TCR-T cells into tumors in post-treatment biopsies

To measure the persistence of T-Plex TCR-T cells in the peripheral blood with single and repeat doses

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

21Treatment groups

Experimental Treatment

Group I: T-Plex Combination Cohort E + FExperimental Treatment2 Interventions

TSC-204-A0101 + TSC-201-B0702

Group II: T-Plex Combination Cohort D + FExperimental Treatment1 Intervention

TSC-203-A0201 + TSC-201B0702

Group III: T-Plex Combination Cohort D + EExperimental Treatment1 Intervention

TSC-203-A0201 + TSC-204A0101

Group IV: T-Plex Combination Cohort C + FExperimental Treatment1 Intervention

TSC-200-A0201 + TSC-201B0702

Group V: T-Plex Combination Cohort C + EExperimental Treatment1 Intervention

TSC-200-A0201 + TSC-204-A0101

Group VI: T-Plex Combination Cohort C + DExperimental Treatment1 Intervention

TSC-200-A0201 + TSC-203-A0201

Group VII: T-Plex Combination Cohort B + FExperimental Treatment1 Intervention

TSC-204-C0702 + TSC-201B0702

Group VIII: T-Plex Combination Cohort B + EExperimental Treatment1 Intervention

TSC-204-C0702 + TSC-204-A0101

Group IX: T-Plex Combination Cohort B + DExperimental Treatment1 Intervention

TSC-204-C0702 + TSC-203-A0201

Group X: T-Plex Combination Cohort B + CExperimental Treatment1 Intervention

TSC-204-C0702 and TSC-200-A0201

Group XI: T-Plex Combination Cohort A + FExperimental Treatment1 Intervention

TSC-204-A0201 + TSC-201-B0702

Group XII: T-Plex Combination Cohort A + EExperimental Treatment1 Intervention

TSC-204-A0201 + TSC-204-A0101

Group XIII: T-Plex Combination Cohort A + DExperimental Treatment1 Intervention

TSC-204-A0201 + TSC-203-A0201

Group XIV: T-Plex Combination Cohort A + CExperimental Treatment2 Interventions

TSC-204-A0201 and TSC-200-A0201

Group XV: T-Plex Combination Cohort A + BExperimental Treatment1 Intervention

TSC-204-A0201 and TSC-204-C0702

Group XVI: Monotherapy Cohort FExperimental Treatment1 Intervention

TSC-201-B0702

Group XVII: Monotherapy Cohort EExperimental Treatment1 Intervention

TSC-204-A0101

Group XVIII: Monotherapy Cohort DExperimental Treatment2 Interventions

TSC-203-A0201

Group XIX: Monotherapy Cohort CExperimental Treatment1 Intervention

TSC-200-A0201

Group XX: Monotherapy Cohort BExperimental Treatment1 Intervention

TSC-204-C0702

Group XXI: Monotherapy Cohort AExperimental Treatment1 Intervention

TSC-204-A0201

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for melanoma include immunotherapies such as checkpoint inhibitors and adoptive cell therapies. Checkpoint inhibitors, like pembrolizumab and nivolumab, work by blocking proteins that prevent T cells from attacking cancer cells, thereby enhancing the immune response against melanoma. Adoptive cell therapies, including TCR-T cell therapies, involve engineering a patient's T cells to express receptors that specifically target cancer-associated antigens, leading to a more precise and potent attack on melanoma cells. These treatments are crucial for melanoma patients as they offer targeted approaches that can lead to significant tumor reduction and prolonged survival, especially in cases where traditional therapies have failed.