Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
completion around
Principal Investigator
by Hyunseok Kang
Headshot of Hyunseok Kang
Hyunseok Kang

Description

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

Official Title

A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas

Details

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.

Keywords

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, 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, Carcinoma, Squamous Cell Carcinoma, Head and Neck Neoplasms, Cyclophosphamide, Fludarabine, SCG142, SCG142 T cells

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Lead Scientist at UCSF

  • Hyunseok Kang
    Dr.Hyunseok "Hyu" Kang is a medical oncologist and a clinician scientist focusing on head and neck cancers including squamous cell carcinomas of head and neck (SCCHN), salivary gland cancers, thyroid cancers and other rare cancers of head and neck.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
SCG Cell Therapy Pte. Ltd.
ID
NCT06505551
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 66 study participants
Last Updated