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Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma

ConditionsHPV-Related Squamous Cell CarcinomaHPV-Related Cervical Squamous Cell CarcinomaHPV-Related Vulvar Squamous Cell CarcinomaHPV-Related Penile Squamous Cell CarcinomaHPV-Related Vaginal Squamous Cell CarcinomaHPV-Related Anal Squamous Cell CarcinomaHPV-Related Head and Neck Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSCG Cell Therapy Pte. Ltd.

About this trial

This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.

Tumor tissue positive for HPV16 or HPV52.

Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.

Human leukocyte antigen (HLA)-A*02:01 genotype.

Disqualifiers

Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.

Active brain metastasis or leptomeningeal metastases.

History of other malignancy within 2 years prior to Screening.

History of organ transplant.

Trial design

Design model

Single group

Treatments tested in this trial

  • SCG142

    Biological/Vaccine

    Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy

  • Cyclophosphamide

    Drug

    for 3 consecutive days

  • Fludarabine

    Drug

    for 3 consecutive days

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: SCG142 T cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events (Phase 1)

Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events.

Time frame
2 years
2

Objective response rate (ORR) (Phase 2)

The proportion of patients with a complete response (CR) or partial response (PR)

Time frame
2 years

Secondary outcomes

1

Objective response rate (ORR) (Phase 1)

The proportion of patients with a complete response (CR) or partial response (PR)

Time frame
2 year
2

Duration of objective response (DOR) (Phase 1&2)

The time from the first occurrence of a confirmed response to disease progression or death from any cause

Time frame
2 year
3

Disease control rate (DCR) (Phase 1&2)

The proportion of patients with a CR, PR or stable disease (SD)

Time frame
2 year
4

Progression-free survival (PFS) (Phase 1&2)

The time from the date of the SCG142 administration to the first occurrence of a progressive disease (PD) or death from any cause

Time frame
2 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SCG Cell Therapy Pte. Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: