SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

NCT ID: NCT06544720

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-02

Study Completion Date

2026-12-31

Brief Summary

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A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.

Detailed Description

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Conditions

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Human Papillomavirus Associated Carcinomas Cervical Cancer Head and Neck Cancers Anal Cancer Vulva Cancer Vaginal Cancer Penile Cancer HPV-Related Malignancy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SCG142 TCR-T cells

Monotherapy of SCG142

Group Type EXPERIMENTAL

SCG142 TCR-T cells

Intervention Type BIOLOGICAL

Monotherapy of SCG142

Interventions

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SCG142 TCR-T cells

Monotherapy of SCG142

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Greater than or equal to 18 years of age
2. HPV associated carcinomas
3. Patients must have at least one measurable lesion defined by RECIST 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria

1. Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.
2. Patients with active autoimmune diseases.
3. Patient has a known active Hepatitis B or Hepatitis C.
4. Other severe medical conditions that may limit subject\'s participation in this trial.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The affiliated hosptial of qingdao university

Qingdao, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongying Lv

Role: CONTACT

+86 18661805217

Facility Contacts

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Hongying Lv

Role: primary

18661805217

Other Identifiers

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SCG142-CI-101

Identifier Type: -

Identifier Source: org_study_id

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