Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCG142, Cyclophosphamide, Fludarabine.
- Who it may be relevant to
- Registry conditions: HPV-Related Squamous Cell Carcinoma, HPV-Related Cervical Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma, HPV-Related Penile Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Biological SCG142
Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy - Drug Cyclophosphamide
for 3 consecutive days - Drug Fludarabine
for 3 consecutive days
Primary outcome measures
- Incidence of Treatment-Emergent Adverse Events (Phase 1) [Time frame: 2 years]
- Objective response rate (ORR) (Phase 2) [Time frame: 2 years]
Secondary outcome measures (6)
- Objective response rate (ORR) (Phase 1) [Time frame: 2 year]
- Duration of objective response (DOR) (Phase 1&2) [Time frame: 2 year]
- Disease control rate (DCR) (Phase 1&2) [Time frame: 2 year]
- Progression-free survival (PFS) (Phase 1&2) [Time frame: 2 year]
- Overall survival (OS) (Phase 1&2) [Time frame: 2 year]
- Incidence of Treatment-Emergent Adverse Events (Phase 2) [Time frame: 2 years]
Eligibility criteria
Main Inclusion Criteria:
- 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.
- Measurable disease as defined by RECIST v1.1.
- Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
- Anticipated life expectancy ≥3 months.
- Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.
Main Exclusion Criteria:
- 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.
- Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- History of active cardiac disease.
- History of active pulmonary disease.
- Active, known, or suspected autoimmune disease.
- Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
- 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.
- Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
- Any serious medical condition or abnormality in clinical laboratory tests.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06505551 · SCG142-UR-102