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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

Summary

This trial uses specially programmed T cells to target cancer-associated molecules in solid tumors to improve safety & efficacy.

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.Check my eligibility
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.See study design
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 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

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

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

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.

Find a Location

Who is running the clinical trial?

TScan Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
993 Total Patients Enrolled
1 Trials studying Melanoma
650 Patients Enrolled for Melanoma
Dawn Pinchasik, MDStudy DirectorTScan Therapeutics
1 Previous Clinical Trials
650 Total Patients Enrolled
1 Trials studying Melanoma
650 Patients Enrolled for Melanoma
Debora Barton, MDStudy DirectorTScan Therapeutics
4 Previous Clinical Trials
1,773 Total Patients Enrolled
1 Trials studying Melanoma
650 Patients Enrolled for Melanoma

Media Library

TSC-200-A0201 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05973487 — Phase 1
Melanoma Research Study Groups: T-Plex Combination Cohort D + F, T-Plex Combination Cohort C + E, T-Plex Combination Cohort B + F, T-Plex Combination Cohort B + E, T-Plex Combination Cohort A + F, T-Plex Combination Cohort A + E, T-Plex Combination Cohort E + F, T-Plex Combination Cohort D + E, T-Plex Combination Cohort C + F, Monotherapy Cohort F, Monotherapy Cohort E, Monotherapy Cohort B, Monotherapy Cohort D, T-Plex Combination Cohort A + D, T-Plex Combination Cohort A + C, T-Plex Combination Cohort B + C, T-Plex Combination Cohort B + D, Monotherapy Cohort C, Monotherapy Cohort A, T-Plex Combination Cohort A + B, T-Plex Combination Cohort C + D
Melanoma Clinical Trial 2023: TSC-200-A0201 Highlights & Side Effects. Trial Name: NCT05973487 — Phase 1
TSC-200-A0201 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05973487 — Phase 1
~67 spots leftby Dec 2026