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HPV-Related Squamous Cell CarcinomaPhase 1/2NCT06505551

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

A Phase 1/2 study testing SCG142, Cyclophosphamide and Fludarabine in people with HPV-Related Squamous Cell Carcinoma and HPV-Related Cervical Squamous Cell Carcinoma, run by SCG Cell Therapy Pte. Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SCG142, Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
No sites listed yet
Study dates
Oct 2024to Dec 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

SCG Cell Therapy contact

(65) 6829 7180

clinicaltrials@scgcell.com

About this study

Official title: 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

Read the 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.

Being tested
SCG142, Cyclophosphamide, Fludarabine
Keywords
Human Papilloma Virus, HPV, Cervical Cancer, Head and Neck Cancer, Oropharyngeal Cancer, Vulvar Cancer, Vaginal Cancer, Penile Cancer, Anal Cancer, Anogenital Cancer, TCR T Cell, Cell therapy, T cell receptor T cell
Medical subject headings
Head and Neck Neoplasms, Uterine Cervical Neoplasms, Oropharyngeal Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Penile Neoplasms, Anus Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCG142Biological

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

  • CyclophosphamideDrug

    for 3 consecutive days

  • FludarabineDrug

    for 3 consecutive days

Study groups in NCT06505551
Study groupRoleWhat they receive
SCG142 T cellsExperimentalThis is a single arm study.
Receives: Biological: SCG142; Drug: Cyclophosphamide; Drug: Fludarabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events (Phase 1)

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

    Measured: 2 years

  2. Objective response rate (ORR) (Phase 2)

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

    Measured: 2 years

Secondary outcomes (6)

  1. Objective response rate (ORR) (Phase 1)

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

    Measured: 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

    Measured: 2 year

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

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

    Measured: 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

    Measured: 2 year

  5. Overall survival (OS) (Phase 1&2)

    The time from date of the SCG142 administration to date of death of any cause

    Measured: 2 year

  6. Incidence of Treatment-Emergent Adverse Events (Phase 2)

    TEAEs

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2024
  2. Study startOct 2024 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06505551
Sponsor's protocol ID
SCG142-UR-102
Status last verified
Jul 2024
First submitted
1 Jul 2024
Last updated
17 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SCG142, Cyclophosphamide and Fludarabine in people with HPV-Related Squamous Cell Carcinoma and HPV-Related Cervical Squamous Cell Carcinoma, run by SCG Cell Therapy Pte. Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact SCG Cell Therapy ((65) 6829 7180, clinicaltrials@scgcell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (Phase 1) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06505551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2024.

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