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

July 10, 2024 updated by: SCG Cell Therapy Pte. Ltd.

A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted in 2 parts:

The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.

The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
  2. Tumor tissue positive for HPV16 or HPV52.
  3. 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.
  4. Human leukocyte antigen (HLA)-A*02:01 genotype.
  5. Measurable disease as defined by RECIST v1.1.
  6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
  7. Anticipated life expectancy ≥3 months.
  8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.

Main Exclusion Criteria:

  1. 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.
  2. Active brain metastasis or leptomeningeal metastases.
  3. History of other malignancy within 2 years prior to Screening.
  4. History of organ transplant.
  5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
  6. History of active cardiac disease.
  7. History of active pulmonary disease.
  8. Active, known, or suspected autoimmune disease.
  9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
  10. Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
  11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
  12. Any serious medical condition or abnormality in clinical laboratory tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCG142 T cells
This is a single arm study.
Biological: SCG142
Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
Drug: Cyclophosphamide
for 3 consecutive days
Drug: Fludarabine
for 3 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events (Phase 1)
Time Frame: 2 years
Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events.
2 years
Objective response rate (ORR) (Phase 2)
Time Frame: 2 years
The proportion of patients with a complete response (CR) or partial response (PR)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) (Phase 1)
Time Frame: 2 year
The proportion of patients with a complete response (CR) or partial response (PR)
2 year
Duration of objective response (DOR) (Phase 1&2)
Time Frame: 2 year
The time from the first occurrence of a confirmed response to disease progression or death from any cause
2 year
Disease control rate (DCR) (Phase 1&2)
Time Frame: 2 year
The proportion of patients with a CR, PR or stable disease (SD)
2 year
Progression-free survival (PFS) (Phase 1&2)
Time Frame: 2 year
The time from the date of the SCG142 administration to the first occurrence of a progressive disease (PD) or death from any cause
2 year
Overall survival (OS) (Phase 1&2)
Time Frame: 2 year
The time from date of the SCG142 administration to date of death of any cause
2 year
Incidence of Treatment-Emergent Adverse Events (Phase 2)
Time Frame: 2 years
TEAEs
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SCG Cell Therapy Pte. Ltd.

Investigators

  • Study Director: SCG Cell Therapy, SCG Cell Therapy Pte. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 10, 2024

First Posted (Actual)

July 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 17, 2024

Last Update Submitted That Met QC Criteria

July 10, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCG142-UR-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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