Human Papillomavirus Associated CarcinomasPhase 1NCT06544720
SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas
A Phase 1 study testing SCG142 TCR-T cells in people with Human Papillomavirus Associated Carcinomas and Cervical Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Papillomavirus Associated Carcinomas, Cervical Cancer, Head and Neck Cancers
- What is being tested?
- SCG142 TCR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 31 Dec 2026
- Phase
- Phase 1
- 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
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The affiliated hosptial of qingdao university
Qingdao, Shandong, 266071
Hongying Lv, 18661805217, qdlhytiger@163.com
About this study
Official title: A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas
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.
- Conditions
- Human Papillomavirus Associated Carcinomas, Cervical Cancer, Head and Neck Cancers, Anal Cancer, Vulva Cancer, Vaginal Cancer
- Being tested
- SCG142 TCR-T cells
- Medical subject headings
- Uterine Cervical Neoplasms, Head and Neck Neoplasms, Anus Neoplasms, Vulvar Neoplasms, Vaginal Neoplasms, Penile Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCG142 TCR-T cellsBiological
Monotherapy of SCG142
| Study group | Role | What they receive |
|---|---|---|
| SCG142 TCR-T cells | Experimental | Monotherapy of SCG142 Receives: Biological: SCG142 TCR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
Measured: 28 days
Secondary outcomes (1)
Efficacy: antitumor activity of SCG142
Assessed by RECIST 1.1 and iRECIST
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start2 Aug 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus Associated CarcinomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544720
- Sponsor's protocol ID
- SCG142-CI-101
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2024
- Last updated
- 9 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas
- ClinicalTrials.gov ID
- NCT06544720
- Acronym / sponsor ID
- SCG142-CI-101
- Conditions
- Human Papillomavirus Associated Carcinomas, Cervical Cancer, Head and Neck Cancers, Anal Cancer, Vulva Cancer, Vaginal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCG142 TCR-T cells | Experimental | Biological: SCG142 TCR-T cellsMonotherapy of SCG142 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCG142 TCR-T cellsMonotherapy of SCG142 | Biological | SCG142 TCR-T cells |
Primary outcome
DLT
Time frame: 28 days
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
1 secondary outcome
Efficacy: antitumor activity of SCG142
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCG142 TCR-T cells in people with Human Papillomavirus Associated Carcinomas and Cervical Cancer, run by The Affiliated Hospital of Qingdao University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 Hongying Lv (+86 18661805217, qdlhytiger@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2024.