Cervical CancerPhase 1NCT05122221
CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
A Phase 1 study testing Fludarabine + Cyclophosphamide, Interleukin-2 and CRTE7A2-01 TCR-T Cell in people with Cervical Cancer and Anal Cancer, run by Corregene Biotechnology Co., Ltd at 1 site in China.
Trial summary
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Cancer, Anal Cancer, Head and Neck Cancers
- What is being tested?
- Fludarabine + Cyclophosphamide, Interleukin-2 and CRTE7A2-01 TCR-T Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2022to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years and ≤65 years.
- Histologically-confirmed cervical cancer, anal cancer, head and neck cancers with confirmed HPV16 infection and HLA-A*02:01 allele
- Failure on or intolerance to systemic therapy for unresectable advanced cancer.
- ECOG performance status of 0-1.
- Estimated life expectancy ≥ 3 months.
- Patients must have at least one measurable lesion defined by RECIST 1.1.
- Female patients of childbearing age must undergo a serum pregnancy test within 7 days prior to study treatment and the results must be negative, and are willing to use a very effective and reliable method of contraception from screening through 6 months after the last dose of study treatment.
- The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.
Who cannot join
- The proportion of T cell immune-related gene deletion mutations>5%.
- Patient received any genetically modified T cell therapy.
- Patient who is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.
- Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.
- Patients with any organ dysfuntion as defined below:
- leukocytes<3.0 x 109/L
Show all 27Show fewer
- absolute neutrophil count >1.5 x 109/L
- hemoglobin<90g/L
- platelets <100 x 1010/L
- lymphocytes<0.8 x 109/L
- percentage of lymphocytes<15%
- creatinine>1.5×ULN or creatinine clearance <50mL/min
- total bilirubin>3×ULN; ALT/AST>3×ULN (patients with liver metastasis,>5×ULN)
- INR>1.5×ULN; APTT>1.5×ULN
- SpO2≤90%
- Patients with serious medical conditions, disorders, and / or comorbidities, including, but are not limited to: severe heart disease, cerebrovascular disease, epileptic seizures, uncontrolled diabetes (CTCAE 5.0: FBG ≥ 2 grade), active infection, active digestive tract Ulcer, gastrointestinal bleeding, intestinal obstruction, pulmonary fibrosis, renal failure, respiratory failure.
- Patient with a severe cardiovascular disease with 6 months before screening, including, but are not limited to, myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass grafting, Heart failure NYHA grade Ⅲ or Ⅳ.
- Left Ventricular Ejection Fractions (LVEF) <50%.
- Patient with a known active brain metastases.
- Patient with a known myelodysplastic syndrome (MDS) or lymphoma.
- Patient with a known active autoimmune disease, including , but are not limited to, acquired or congenital immunodeficiency disease, allogeneic organ transplantation, autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease.
- Patient with a known active Hepatitis B or Hepatitis C.
- Patient with a history of Human Immunodeficiency Virus (HIV) .
- Patient with a history of syphilis.
- Pregnant or lactating women.
- Patient with a known active mental and neurological diseases.
- The principal investigator judged that it is not suitable to participate in this clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Yi Zhang, Doctor, 0371-66295320, yizhang@zzu.edu.cn
Yi Zhang, Doctor
About this study
Official title: A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cell for HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
A single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.
- Conditions
- Cervical Cancer, Anal Cancer, Head and Neck Cancers
- Being tested
- Fludarabine + Cyclophosphamide, Interleukin-2, CRTE7A2-01 TCR-T Cell
- Keywords
- 3+3 dose escalation
- Medical subject headings
- Uterine Cervical Neoplasms, Anus Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fludarabine + CyclophosphamideDrug
Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days
Interleukin-2Drug
Interleukin-2 20,000,000 IU/time infused within 15 minutes approximately every 8 hours (according to the subject's tolerance, the interval between medications can be extended to 24 hours) for a maximum usage time up to 14 days.
CRTE7A2-01 TCR-T CellBiological
On day 0, the TCR-T cells will be administered one time, each bag of cell intravenously within 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| CRTE7A2-01 TCR-T cell therapy | Experimental | Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2 Receives: Drug: Fludarabine + Cyclophosphamide; Drug: Interleukin-2; Biological: CRTE7A2-01 TCR-T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum Tolerated Dose
Measured: 28 days
DLT
Dose-limiting toxicity
Measured: 28 days
RP2D
Recommended Phase II Dose
Measured: 28 days
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
grade 1-5 (CTCAE)
Measured: 2 years
Secondary outcomes (4)
Objective Response Rate（ORR）
Assessed by RECIST 1.1
Measured: 2 years
Disease Control Rate（DCR）
Assessed by RECIST 1.1
Measured: 2 years
Duration of Response（DOR）
Assessed by RECIST 1.1
Measured: 2 years
Progression-Free Survival（PFS）
Assessed by RECIST 1.1
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 posted16 Nov 2021
- Study start17 Jul 2022 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corregene Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122221
- Sponsor's protocol ID
- CRTE7A2-2107C
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 28 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cell for HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
- ClinicalTrials.gov ID
- NCT05122221
- Acronym / sponsor ID
- CRTE7A2-2107C
- Conditions
- Cervical Cancer, Anal Cancer, Head and Neck Cancers
- Keywords
- 3+3 dose escalation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Corregene Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2022 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Nov 2021 (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 single center, open, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRTE7A2-01 TCR-T cell therapy | Experimental | Drug: Fludarabine + Cyclophosphamide, Drug: Interleukin-2, Biological: CRTE7A2-01 TCR-T CellPatients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years and ≤65 years.
- Histologically-confirmed cervical cancer, anal cancer, head and neck cancers with confirmed HPV16 infection and HLA-A*02:01 allele
- Failure on or intolerance to systemic therapy for unresectable advanced cancer.
- ECOG performance status of 0-1.
- Estimated life expectancy ≥ 3 months.
Key exclusion criteria (27 listed)
- The proportion of T cell immune-related gene deletion mutations>5%.
- Patient received any genetically modified T cell therapy.
- Patient who is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.
- Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.
- Patients with any organ dysfuntion as defined below:
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 |
|---|---|---|
| Fludarabine + CyclophosphamideFludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days | Drug | CRTE7A2-01 TCR-T cell therapy |
| Interleukin-2Interleukin-2 20,000,000 IU/time infused within 15 minutes approximately every 8 hours (according to the subject's tolerance, the interval between medications can be extended to 24 hours) for a maximum usage time up to 14 days. | Drug | CRTE7A2-01 TCR-T cell therapy |
| CRTE7A2-01 TCR-T CellOn day 0, the TCR-T cells will be administered one time, each bag of cell intravenously within 20 minutes. | Biological | CRTE7A2-01 TCR-T cell therapy |
Primary outcome
MTD
Time frame: 28 days
Maximum Tolerated Dose
DLT
Time frame: 28 days
Dose-limiting toxicity
RP2D
Time frame: 28 days
Recommended Phase II Dose
Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).
Time frame: 2 years
grade 1-5 (CTCAE)
4 secondary outcomes
Objective Response Rate（ORR）
Time frame: 2 years
Disease Control Rate（DCR）
Time frame: 2 years
Duration of Response（DOR）
Time frame: 2 years
Progression-Free Survival（PFS）
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
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 Fludarabine + Cyclophosphamide, Interleukin-2 and CRTE7A2-01 TCR-T Cell in people with Cervical Cancer and Anal Cancer, run by Corregene Biotechnology Co., Ltd 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 8 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 28 Jun 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sa Wang, Master (8610-86464526-840, wangsa@corregene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 28 days). The study lists 4 primary outcomes in all. 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 28 Jun 2022.