Anal Cancer, Cervical Cancer, Head and Neck Cancers, HPV-Related Malignancy, Human Papillomavirus Associated Carcinomas, Penile Cancer, Vaginal Cancer, Vulva Cancer
Conditions
Brief 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.
Interventions
BIOLOGICALSCG142 TCR-T cells
Monotherapy of SCG142
Sponsors
The Affiliated Hospital of Qingdao University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT | 28 days | Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: antitumor activity of SCG142 | 2 years | Assessed by RECIST 1.1 and iRECIST |
Countries
China
Contacts
Primary ContactHongying Lv
Outcome results
None listed