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SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

Q

Qingdao University

Status and phase

Enrolling
Phase 1

Conditions

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

Treatments

Biological: SCG142 TCR-T cells

Study type

Interventional

Funder types

Other

Identifiers

NCT06544720
SCG142-CI-101

Details and patient eligibility

About

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.

Enrollment

18 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

18 participants in 1 patient group

SCG142 TCR-T cells
Experimental group
Description:
Monotherapy of SCG142
Treatment:
Biological: SCG142 TCR-T cells

Trial contacts and locations

1

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Central trial contact

Hongying Lv

Data sourced from clinicaltrials.gov

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