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Cervical CancerPhase 1NCT06358053

CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers

A Phase 1 study testing CRTE7A2-01 TCR-T cell therapy in people with Cervical Cancer and Anal Cancer, run by Corregene Biotechnology Co., 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

A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
CRTE7A2-01 TCR-T cell therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
No sites listed yet
Study dates
15 Apr 2024to 30 Apr 2028
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Age >18 years and 65 years. 2. Patients with advanced solid tumors (such as cervical cancer, head and neck tumors, anal cancer, and other malignancies) who have failed standard treatment confirmed by histology and/or cytology, or who are intolerant to such treatment, and for whom there is no effective therapy available after standard treatment failure are considered as end-stage patients. Specifically for:
  • Cervical cancer: a) Patients who have previously failed at least second-line systemic therapy (including at least one platinum-based regimen or anti-angiogenic therapy) and have shown disease progression or intolerance confirmed by pathological or radiological examination during or after the most recent treatment course, and are not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic cervical cancer.
  • Nasopharyngeal cancer: a) Patients who have previously failed at least third-line systemic therapy or are intolerant, not amenable to treatment with surgery or radiotherapy, with no standard treatment options currently available for recurrent or metastatic nasopharyngeal cancer; b) EB virus negative.
  • Head and neck squamous cell carcinoma: a) Patients who have previously failed at least second-line systemic therapy or are intolerant, with no standard treatment options currently available for recurrent or metastatic head and neck squamous cell carcinoma (non-nasal).
  • 3. Confirmation of HPV16 positive and HLA-A02:01 allele. 4. ECOG performance status of 0-1. 5. Estimated life expectancy ≥ 3 months. 6. Patients must have at least one measurable lesion defined by RECIST 1.1. 7. 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.
  • 8. The patient must be willing to sign the informed consent form and have a good anticipation of compliance with study procedure.

Who cannot join

  • Patient received any genetically modified T cell therapy.
  • Patient 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 have any organ system function impairment as defined below:
  • leukocytes<3.0 x 109/L
  • absolute neutrophil count >1.5 x 109/L
Show all 18Show fewer
  • hemoglobin<90g/L
  • platelets <100 x 1010/L
  • lymphocytes<0.5 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%
  • 6. Patinets has 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.
  • 7. Patient has 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.
  • 8. Left Ventricular Ejection Fractions (LVEF) <50%. 9. Patient has a known active brain metastases. 10. Patient has a known myelodysplastic syndrome (MDS) or lymphoma. 11. Patient has 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.
  • 12. Patient has a known active Hepatitis B or Hepatitis C. 13. Patient has a history of Human Immunodeficiency Virus (HIV) . 14. Patient has a history of syphilis. 15. Pregnant or lactating women. 16. Patient has a known active mental and neurological diseases. 17. The principal investigator judged that it is not suitable to participate in this clinical study.

Trial locations and contacts

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

Sa Wang, Master contact

010-86464526

wangsa@corregene.com

About this study

Official title: A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cells in HLA-A*02:01+ Subjects With HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers and Other Solid Tumors

A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.

Being tested
CRTE7A2-01 TCR-T cell therapy
Keywords
HPV, E7, immunotherapy, T cell, Adoptive cell therapy, T cell receptor, TCR
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.

  • CRTE7A2-01 TCR-T cell therapyDrug

    Also called CRTE7A2

    Drug 1: Fludarabine + Cyclophosphamide Drug 2: Interleukin-2 Drug 3: CRTE7A2-01 TCR-T Cell

Study groups in NCT06358053
Study groupRoleWhat they receive
CRTE7A2-01 TCR-T cell therapyExperimentalThis study is a single-arm Phase I study, encompassing both dose escalation and dose expansion phases. Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2
Receives: Drug: CRTE7A2-01 TCR-T cell therapy

What is being measured

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

  1. DLT

    Dose-limiting toxicity

    Measured: 28 days

  2. RP2D

    Recommended Phase 2 Dose

    Measured: 2 years

  3. cevents (SAEs).

    Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs).

    Measured: 2 years

Secondary outcomes (5)

  1. Objective Response Rate (ORR)

    Assessed by RECIST 1.1

    Measured: 2 years

  2. Disease Control Rate (DCR)

    Assessed by RECIST 1.1

    Measured: 2 years

  3. Duration of Response (DOR)

    Assessed by RECIST 1.1

    Measured: 2 years

  4. Progression-Free Survival (PFS)

    Assessed by RECIST 1.1

    Measured: 2 years

  5. Overall Survival(OS)

    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.

  1. First posted10 Apr 2024
  2. Study start15 Apr 2024 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Apr 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06358053
Sponsor's protocol ID
CRTE7A2-2302C
Status last verified
Apr 2024
First submitted
2 Apr 2024
Last updated
10 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CRTE7A2-01 TCR-T cell therapy in people with Cervical Cancer and Anal Cancer, run by Corregene Biotechnology Co., Ltd.

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 6 inclusion and 18 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: opening soon, as of the sponsor's last update on 10 Apr 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 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 Sa Wang, Master (010-86464526, wangsa@corregene.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). The study lists 3 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 NCT06358053.

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 10 Apr 2024.

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