SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Affiliated Hospital of Qingdao University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Greater than or equal to 18 years of age

HPV associated carcinomas

Patients must have at least one measurable lesion defined by RECIST 1.1

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Disqualifiers

Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.

Patients with active autoimmune diseases.

Patient has a known active Hepatitis B or Hepatitis C.

Other severe medical conditions that may limit subject's participation in this trial.

Trial design

Design model

Single group

Treatments tested in this trial

  • SCG142 TCR-T cells

    Biological/Vaccine

    Monotherapy of SCG142

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: SCG142 TCR-T cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLT

Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)

Time frame
28 days

Secondary outcomes

1

Efficacy: antitumor activity of SCG142

Assessed by RECIST 1.1 and iRECIST

Time frame
2 years

Other outcomes

Sponsors and contacts

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