Trial Title:
A Basket Study of Customized Autologous TCR-T Cell Therapies in Patients With Locally Advanced (Unresectable) or Metastatic Solid Tumors
NCT ID:
NCT05973487
Condition:
Head and Neck Cancer
Cervical Cancer
Non-small Cell Carcinoma
Melanoma
Ovarian Cancer
Anogenital Cancers
HPV - Anogenital Human Papilloma Virus Infection
HPV-Related Cervical Carcinoma
HPV-Related Carcinoma
HPV-Related Squamous Cell Carcinoma
HPV-Related Malignancy
HPV-Related Adenocarcinoma
HPV Positive Oropharyngeal Squamous Cell Carcinoma
HPV-Related Adenosquamous Carcinoma
HPV-Associated Vaginal Adenocarcinoma
HPV-Related Endocervical Adenocarcinoma
HPV-Related Anal Squamous Cell Carcinoma
HPV-Related Verrucous Carcinoma
HPV-Related Penile Squamous Cell Carcinoma
HPV-Related Vulvar Squamous Cell Carcinoma
HPV Positive Rectal Squamous Cell Carcinoma
Conditions: Official terms:
Papillomavirus Infections
Carcinoma
Carcinoma, Squamous Cell
Adenocarcinoma
Carcinoma, Verrucous
Papilloma
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Adenosquamous
Trans-sodium crocetinate
Conditions: Keywords:
HPV16 E7
MAGE-A1
TCR-T Therapy
Cell Therapy
Immunotherapy
TScan Therapeutics
TSCAN-002
TSCAN-003
PRAME
MAGE-C2
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
TSC-204-A0201
Description:
Escalating doses of TSC-204-A0201 as a monotherapy
Arm group label:
Monotherapy Cohort A
Intervention type:
Biological
Intervention name:
TSC-204-C0702
Description:
Escalating doses of TSC-204-C0702 as a monotherapy
Arm group label:
Monotherapy Cohort B
Intervention type:
Biological
Intervention name:
TSC-200-A0201
Description:
Escalating doses of TSC-200-A0201 as a monotherapy
Arm group label:
Monotherapy Cohort C
Intervention type:
Biological
Intervention name:
TSC-204-A0201 + TSC-204-C0702
Description:
Escalating doses of TSC-204-A0201 in combination with TSC-204-C0702
Arm group label:
T-Plex Combination Cohort A + B
Intervention type:
Biological
Intervention name:
TSC-204-A0201 + TSC-200-A0201
Description:
Escalating doses of TSC-204-A0201 in combination with TSC-200-A0201
Arm group label:
T-Plex Combination Cohort B + C
Intervention type:
Biological
Intervention name:
TSC-204-C0702 + TSC-200-A0201
Description:
Escalating doses of TSC-204-C0702 in combination with TSC-200-A0201
Arm group label:
T-Plex Combination Cohort A + C
Intervention type:
Biological
Intervention name:
TSC-204-A0201 + TSC-203-A0201
Description:
Escalating doses of TSC-204-A0201 in combination with TSC-203-A0201
Arm group label:
T-Plex Combination Cohort A + D
Intervention type:
Biological
Intervention name:
TSC-204-C0702 + TSC-203-A0201
Description:
Escalating doses of TSC-204-C0702 in combination with TSC-203-A0201
Arm group label:
T-Plex Combination Cohort B + D
Intervention type:
Biological
Intervention name:
TSC-200-A0201 + TSC-203-A0201
Description:
Escalating doses of TSC-200-A0201 in combination with TSC-203-A0201
Arm group label:
T-Plex Combination Cohort C + D
Intervention type:
Biological
Intervention name:
TSC-203-A0201
Description:
Escalating doses of TSC-203-A0201 as a monotherapy
Arm group label:
Monotherapy Cohort D
Intervention type:
Biological
Intervention name:
TSC-204-A0101
Description:
Escalating doses of TSC-204-A0101 as a monotherapy
Arm group label:
Monotherapy Cohort E
Arm group label:
T-Plex Combination Cohort E + F
Intervention type:
Biological
Intervention name:
TSC-201-B0702
Description:
Escalating doses of TSC-201-B0702 as a monotherapy
Arm group label:
Monotherapy Cohort F
Arm group label:
T-Plex Combination Cohort E + F
Intervention type:
Biological
Intervention name:
TSC-204-A0201 + TSC-204-A0101
Description:
Escalating doses of TSC-204-A0201 in combination with TSC-204-A0101
Arm group label:
T-Plex Combination Cohort A + E
Intervention type:
Biological
Intervention name:
TSC-204-A0201 + TSC-201-B0702
Description:
Escalating doses of TSC-204-A0201 in combination with TSC-201-B0702
Arm group label:
T-Plex Combination Cohort A + F
Intervention type:
Biological
Intervention name:
TSC-204-C0702 + TSC-204-A0101
Description:
Escalating doses of TSC-204-C0702 in combination with TSC-204-A0101
Arm group label:
T-Plex Combination Cohort B + E
Intervention type:
Biological
Intervention name:
TSC-204-C0702 + TSC-201-B0702
Description:
Escalating doses of TSC-204-C0702 in combination with TSC-201-B0702
Arm group label:
T-Plex Combination Cohort B + F
Intervention type:
Biological
Intervention name:
TSC-200-A0201 + TSC-204-A0101
Description:
Escalating doses of TSC-200-A0201 in combination with TSC-204-A0101
Arm group label:
T-Plex Combination Cohort C + E
Intervention type:
Biological
Intervention name:
TSC-200-A0201 + TSC-201-B0702
Description:
Escalating doses of TSC-200-A0201 in combination with TSC-201-B0702
Arm group label:
T-Plex Combination Cohort C + F
Intervention type:
Biological
Intervention name:
TSC-203-A0201 + TSC-204-A0101
Description:
Escalating doses of TSC-203-A0201 in combination with TSC-204-A0101
Arm group label:
T-Plex Combination Cohort D + E
Intervention type:
Biological
Intervention name:
TSC-203-A0201 + TSC-201-B0702
Description:
Escalating doses of TSC-203-A0201 in combination with TSC-201-B0702
Arm group label:
T-Plex Combination Cohort D + F
Summary:
TScan Therapeutics is developing cellular therapies across multiple solid tumors in which
autologous participant-derived T cells are engineered to express a T cell receptor that
recognizes cancer-associated antigens presented on specific Human Leukocyte Antigen (HLA)
molecules.
This is a multi-center, non-randomized, multi-arm, open-label, basket study evaluating
the safety and preliminary efficacy of single and repeat dose regimens of TCR'Ts as
monotherapies and as T-Plex combinations after lymphodepleting chemotherapy in
participants with locally advanced, metastatic solid tumors disease.
Detailed description:
Participants will be screened in a separate screening study, TSCAN-003 (NCT05812027), to
assess their HLA type, tumor-associated antigen (TAA) expression and loss of
heterozygosity (LOH) status. The results of these tests will be used to determine initial
eligibility in this study.
Depending on the genetic type, participants will be assigned to one of the following
study groups:
Monotherapy:
- COHORT A: TSC-204-A0201 targeting MAGE-A1 on HLA-A*02:01
- COHORT B: TSC-204-C0702 targeting MAGE-A1 on HLA-C*07:02
- COHORT C: TSC-200-A0201 targeting HPV16 E7 on HLA-A*02:01
- COHORT D: TSC-203-A0201 targeting PRAME on HLA-A*02:01
- COHORT E: TSC-204-A0101 targeting MAGE-A1 on HLA-A*01:01
- COHORT F: TSC-201-B0702 targeting MAGE-C2 on HLA-B*07:02
T-Plex Combination:
- COHORT AB: TSC-204-A0201 + TSC-204-C0702
- COHORT AC: TSC-204-A0201 + TSC-200-A0201
- COHORT AD: TSC-204-A0201 + TSC-203-A0201
- COHORT AE: TSC-204-A0201 + TSC-204-A0101
- COHORT AF: TSC-204-A0201 + TSC-201-B0702
- COHORT BC: TSC-204-C0702 + TSC-200-A0201
- COHORT BD: TSC-204-C0702 + TSC-203-A0201
- COHORT BE: TSC-204-C0702 + TSC-204-A0101
- COHORT BF: TSC-204-C0702 + TSC-201-B0702
- COHORT CD: TSC-200-A0201 + TSC-203-A0201
- COHORT CE: TSC-200-A0201 + TSC-204-A0101
- COHORT CF: TSC-200-A0201 + TSC-201-B0702
- COHORT DE: TSC-203-A0201 + TSC-204-A0101
- COHORT DF: TSC-203-A0201 + TSC-201-B0702
- COHORT EF: TSC-204-A0101 + TSC-201-B0702
Participants will undergo leukapheresis to collect cells to manufacture the TCR-T
products. They will then undergo lymphodepletion and receive one or two doses of the
TCR-T cell therapy product as a monotherapy or part of a combination of TCR-Ts (referred
to as T-Plex combinations in this study).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Must be at least 18 years.
2. Locally advanced (unresectable) or metastatic solid tumor for which there are no
available curative treatment options, after failure of the standard of care systemic
therapies for that particular indication.
3. Solid tumors, including but not limited to non-nasopharyngeal head and neck cancer,
non-small cell lung cancer, cutaneous melanoma, cervical cancer, ovarian cancer,
anal cancer and genital cancers. Other tumor types may be permitted if approved by
TScan.
4. Participants must express one of the following HLA types, as assessed by a qualified
genomics assay in screening study TSCAN-003:
HLA-B*07:02 HLA-A*01:01 HLA-C*07:02 HLA-A*02:01
5. Tumor must express one or more of the following: MAGE-A1, MAGE-C2, PRAME and
HPV16-E7 assessed in the last 8 months in screening study TSCAN-003 (NCT05812027).
6. Eastern Cooperative Oncology Group (ECOG) Performance status 0-1 at screening.
7. Participants must be able to understand and be willing to give informed consent;
decision-impaired adults may consent with their legally authorized representative.
8. At least 1 measurable lesion per modified Response Evaluation Criteria in Solid
Tumors (RECIST) v1.1.
9. Adequate bone marrow and organ function.
Exclusion Criteria:
1. Medical or psychological conditions that would make the participant unsuitable
candidate for cell therapy at the discretion of the PI.
2. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina,
cardiac arrhythmia requiring antiarrhythmic or procedure, or other clinically
significant cardiac disease within 12 months of enrollment
3. History of stroke or transient ischemic attack (TIA) within 12 months of enrollment
4. Systemic corticosteroid therapy >10 mg of prednisone daily or equivalent within 7
days of enrollment
5. History of severe hypersensitivity to fludarabine or cyclophosphamide or study
product excipients including human serum albumin, Cryostor (DMSO or Dextran 40), or
Plasma-Lyte.
6. Untreated or symptomatic central nervous system (CNS) metastases or cytology proven
carcinomatous meningitis.
7. Concurrent receipt of another anti-cancer therapy.
8. Presence of fungal, bacterial, viral, or other infection requiring anti-microbials
for management.
9. Tumors that have HLA LOH using a central lab clinical trial assay of HLAs addressed
by the monotherapy and/or T-Plex combination TCR-Ts in the protocol and have no
available TCR-T options for intact HLAs in the participant's tumor.
10. Participants who regularly require supplemental oxygen.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
HonorHealth Research and Innovation Institute
Address:
City:
Scottsdale
Zip:
85258
Country:
United States
Status:
Recruiting
Contact:
Last name:
Justin Moser, MD
Phone:
480-323-1364
Email:
clinicaltrials@honorhealth.com
Facility:
Name:
Yale Cancer Center
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jialing Zhang
Phone:
475-234-9684
Email:
Jialing.zhang@yale.edu
Investigator:
Last name:
Michael Hurwitz, MD
Email:
Principal Investigator
Facility:
Name:
Memorial Healthcare System
Address:
City:
Hollywood
Zip:
33021
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Pico, MD
Phone:
954-265-1847
Email:
bpico@mhs.net
Facility:
Name:
University of Miami, Sylvester Comprehensive Cancer Center
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marialby Donis Ramos
Phone:
305-243-1000
Email:
mxd4514@med.miami.edu
Investigator:
Last name:
Jose Lutzky, MD
Email:
Principal Investigator
Facility:
Name:
Orlando Health
Address:
City:
Orlando
Zip:
32806
Country:
United States
Status:
Recruiting
Contact:
Last name:
Melinda Porter
Phone:
321-841-7246
Email:
janice.porter@orlandohealth.com
Investigator:
Last name:
Sajeve Thomas, MD
Email:
Principal Investigator
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ben Orem
Phone:
502-629-2500
Phone ext:
19471
Email:
ben.orem@nortonhealthcare.org
Investigator:
Last name:
Jaspreet Grewal, MD
Email:
Principal Investigator
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marie Ventimiglia
Phone:
313-576-9271
Email:
ventimim@karmanos.org
Investigator:
Last name:
Ira Winer, MD
Email:
Principal Investigator
Facility:
Name:
University of Minnesota Masonic Cancer Center
Address:
City:
Minneapolis
Zip:
55455
Country:
United States
Status:
Recruiting
Contact:
Last name:
Manar Al-Assi
Email:
malassi@umn.edu
Facility:
Name:
Columbia University Herbert Irving Comprehensive Cancer Center
Address:
City:
New York
Zip:
10032
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Shelton, MPH
Phone:
212-342-0248
Email:
cancerclinicaltrials@cumc.columbia.edu
Investigator:
Last name:
Brian Henick, MD
Email:
Principal Investigator
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
UNC Immunotherapy Team
Phone:
919-445-4208
Email:
UNCImmunotherapy@med.unc.edu
Investigator:
Last name:
Jared Weiss, MD
Email:
Principal Investigator
Facility:
Name:
The Cleveland Clinic
Address:
City:
Cleveland
Zip:
44195
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cancer Answer Line
Phone:
216-444-7923
Investigator:
Last name:
James Isaacs, MD
Email:
Principal Investigator
Facility:
Name:
OU Health Stephenson Cancer Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cynthia Lowery
Email:
Cynthia-Lowery@ouhsc.edu
Investigator:
Last name:
Manu Pandey, MD
Email:
Principal Investigator
Facility:
Name:
Providence Cancer Institute Franz Clinic
Address:
City:
Portland
Zip:
97213
Country:
United States
Status:
Recruiting
Contact:
Last name:
Rom Leidner, MD
Phone:
503-215-2614
Email:
CanRsrchStudies@providence.org
Investigator:
Last name:
Rom Leidner, MD
Email:
Principal Investigator
Facility:
Name:
Allegheny Hospitals Network
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Shelly Evans
Email:
shelly.evans@ahn.org
Investigator:
Last name:
Yazan Samhouri, MD
Email:
Principal Investigator
Facility:
Name:
University of Pittsburgh Medical Center
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Barb Stadterman
Email:
stadtermanbm@upmc.edu
Investigator:
Last name:
Jason Luke, MD
Email:
Principal Investigator
Start date:
May 6, 2024
Completion date:
December 30, 2026
Lead sponsor:
Agency:
TScan Therapeutics, Inc.
Agency class:
Industry
Source:
TScan Therapeutics, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05973487
