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

NCT06505551 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SCG142-UR-102
• Study Type: interventional
• Target: 66
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

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

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

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events (Phase 1)

  Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events.

  2 years

• Objective response rate (ORR) (Phase 2)

  The proportion of patients with a complete response (CR) or partial response (PR)

  2 years

Secondary Outcomes (6)

• Objective response rate (ORR) (Phase 1)

  2 year

• Duration of objective response (DOR) (Phase 1&2)

  2 year

• Disease control rate (DCR) (Phase 1&2)

  2 year

• Progression-free survival (PFS) (Phase 1&2)

  2 year

• Overall survival (OS) (Phase 1&2)

  2 year

Study Arms (1)

SCG142 T cells

EXPERIMENTAL

This is a single arm study.

Biological: SCG142; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

SCG142 BIOLOGICAL

Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy

SCG142 T cells

Cyclophosphamide DRUG

for 3 consecutive days

SCG142 T cells

Fludarabine DRUG

for 3 consecutive days

SCG142 T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SCG Cell Therapy Pte. Ltd.: lead

MeSH Terms

Conditions

Head and Neck Neoplasms; Uterine Cervical Neoplasms; Oropharyngeal Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Penile Neoplasms; Anus Neoplasms

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Vulvar Diseases; Vaginal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Penile Diseases; Male Urogenital Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• SCG Cell Therapy

  SCG Cell Therapy Pte. Ltd.

  STUDY DIRECTOR

Central Study Contacts

SCG Cell Therapy

CONTACT

(65) 6829 7180; clinicaltrials@scgcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 17, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share