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Trial Title:
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas
NCT ID:
NCT06544720
Condition:
Human Papillomavirus Associated Carcinomas
Cervical Cancer
Head and Neck Cancers
Anal Cancer
Vulva Cancer
Vaginal Cancer
Penile Cancer
HPV-Related Malignancy
Conditions: Official terms:
Carcinoma
Anus Neoplasms
Vaginal Neoplasms
Penile Neoplasms
Vulvar Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
SCG142 TCR-T cells
Description:
Monotherapy of SCG142
Arm group label:
SCG142 TCR-T cells
Summary:
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.
Criteria for eligibility:
Criteria:
Key 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
Key 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The affiliated hosptial of qingdao university
Address:
City:
Qingdao
Zip:
266071
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongying Lv
Phone:
18661805217
Email:
qdlhytiger@163.com
Start date:
August 2, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
The Affiliated Hospital of Qingdao University
Agency class:
Other
Source:
The Affiliated Hospital of Qingdao University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06544720
