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Trial Title:
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
NCT ID:
NCT06505551
Condition:
HPV-Related Squamous Cell Carcinoma
HPV-Related Cervical Squamous Cell Carcinoma
HPV-Related Vulvar Squamous Cell Carcinoma
HPV-Related Penile Squamous Cell Carcinoma
HPV-Related Vaginal Squamous Cell Carcinoma
HPV-Related Anal Squamous Cell Carcinoma
HPV-Related Head and Neck Cancer
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Cyclophosphamide
Fludarabine
Conditions: Keywords:
Human Papilloma Virus
HPV
Cervical Cancer
Head and Neck Cancer
Oropharyngeal Cancer
Vulvar Cancer
Vaginal Cancer
Penile Cancer
Anal Cancer
Anogenital Cancer
TCR T Cell
Cell therapy
T cell receptor T cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SCG142
Description:
Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
Arm group label:
SCG142 T cells
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
for 3 consecutive days
Arm group label:
SCG142 T cells
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
for 3 consecutive days
Arm group label:
SCG142 T cells
Summary:
This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced
or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one
line of systemic therapy, including but not limited to combination chemotherapy and/or
combination chemo-immunotherapy
Detailed description:
This study will be conducted in 2 parts:
The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate
the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142
in the same patient populations.
Criteria for eligibility:
Criteria:
Main Inclusion Criteria:
1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the
following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
2. Tumor tissue positive for HPV16 or HPV52.
3. Advanced or metastatic carcinoma with progression after at least 1 line of standard
of care systemic therapies, including but not limited to combination chemotherapy
and/or combination chemo-immunotherapy.
4. Human leukocyte antigen (HLA)-A*02:01 genotype.
5. Measurable disease as defined by RECIST v1.1.
6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
7. Anticipated life expectancy ≥3 months.
8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation
function.
Main Exclusion Criteria:
1. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular
ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with
central nervous system (CNS) involvement.
2. Active brain metastasis or leptomeningeal metastases.
3. History of other malignancy within 2 years prior to Screening.
4. History of organ transplant.
5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency
syndrome (AIDS).
6. History of active cardiac disease.
7. History of active pulmonary disease.
8. Active, known, or suspected autoimmune disease.
9. Lack of peripheral venous or central venous access, or any condition that may
prevent trial sample collection and administration of SCG142.
10. Prior exposure to any cell therapy including, but not limited to natural killer (NK)
cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T
lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of
SCG142.
12. Any serious medical condition or abnormality in clinical laboratory tests.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 2024
Completion date:
December 2028
Lead sponsor:
Agency:
SCG Cell Therapy Pte. Ltd.
Agency class:
Industry
Source:
SCG Cell Therapy Pte. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06505551
