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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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
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
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or restricted in physically strenuous activity but can do light work.I have not taken more than 10 mg of prednisone daily in the last week.I have not had a stroke or TIA in the last year.My cancer is advanced, cannot be surgically removed, and has not responded to standard treatments.I regularly need extra oxygen.My tumor lacks certain genes and I have no T-cell therapy options.I have untreated brain metastases or cancer in my spinal fluid.I have a solid tumor such as lung, skin, cervical, ovarian, anal, or genital cancer.My bone marrow and organs are functioning well.I am currently taking medication for an infection.I am 18 years old or older.I do not have any health or mental conditions that would prevent me from receiving cell therapy.I haven't had a heart attack or other major heart issues in the last year.I understand the study and agree to participate.My genetic makeup includes HLA-C*07:02 and HLA-A*02:01.My tumor tests positive for MAGE-A1, PRAME, or HPV16-E7.
Research Study Groups:
This trial has the following groups:- Group 1: T-Plex Combination Cohort D + F
- Group 2: T-Plex Combination Cohort B + F
- Group 3: T-Plex Combination Cohort C + E
- Group 4: T-Plex Combination Cohort A + E
- Group 5: Monotherapy Cohort E
- Group 6: T-Plex Combination Cohort C + F
- Group 7: T-Plex Combination Cohort E + F
- Group 8: T-Plex Combination Cohort B + E
- Group 9: T-Plex Combination Cohort A + F
- Group 10: Monotherapy Cohort F
- Group 11: T-Plex Combination Cohort D + E
- Group 12: Monotherapy Cohort B
- Group 13: Monotherapy Cohort D
- Group 14: T-Plex Combination Cohort A + D
- Group 15: T-Plex Combination Cohort A + C
- Group 16: T-Plex Combination Cohort B + C
- Group 17: T-Plex Combination Cohort B + D
- Group 18: Monotherapy Cohort C
- Group 19: Monotherapy Cohort A
- Group 20: T-Plex Combination Cohort A + B
- Group 21: T-Plex Combination Cohort C + D
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Monotherapy Cohort A undergone regulatory scrutiny?
"Our team at Power appraised the safety of Monotherapy Cohort A as a 1 due to its status in Phase 1 trials, which implies that there is scant evidence affirming its efficacy and security."
Answered by AI
Is this experiment accepting new participants?
"This clinical trial is presently not accepting patients according to information hosted on clinicaltrials.gov; the study was first posted August 31st 2023 and its most recent edits were made on August 1st 2023. Nonetheless, there are over 1500 other medical studies currently signing up volunteers for their respective trials."
Answered by AI
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