Health Trials

Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma

ConditionsHPV-Related Squamous Cell CarcinomaHPV-Related Cervical Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vaginal Squamous Cell CarcinomaHPV-Related Anal Squamous Cell CarcinomaHPV-Related Head and Neck Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSCG Cell Therapy Pte. Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.

Tumor tissue positive for HPV16 or HPV52.

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.

Human leukocyte antigen (HLA)-A*02:01 genotype.

Disqualifiers

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.

Active brain metastasis or leptomeningeal metastases.

History of other malignancy within 2 years prior to Screening.

History of organ transplant.

Trial design

Treatments tested in this trial

  • SCG142
  • Cyclophosphamide
  • Fludarabine

Treatment groups

66 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators

SCG Cell Therapy Pte. Ltd.

Lead sponsor

Source ClinicalTrials.gov