CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
NCT ID: NCT05122221
Last Updated: 2022-06-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
12 participants
INTERVENTIONAL
2022-07-17
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CRTE7A2-01 TCR-T cell therapy
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2
Fludarabine + Cyclophosphamide
Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days
Interleukin-2
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 Cell
On day 0, the TCR-T cells will be administered one time, each bag of cell intravenously within 20 minutes.
Interventions
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Fludarabine + Cyclophosphamide
Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days
Interleukin-2
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 Cell
On day 0, the TCR-T cells will be administered one time, each bag of cell intravenously within 20 minutes.
Eligibility Criteria
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Inclusion Criteria
2. Histologically-confirmed cervical cancer, anal cancer, head and neck cancers with confirmed HPV16 infection and HLA-A\*02:01 allele
3. Failure on or intolerance to systemic therapy for unresectable advanced cancer.
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.
Exclusion Criteria
2. Patient received any genetically modified T cell therapy.
3. Patient who is being treated with T cell immunosuppressive agent （such as cyclophosphamide, FK506,tripterygium glycosides） or T cell immunoagonist.
4. Patients received chemotherapy, targeted therapy, immunotherapy, or other investigational agents within 2 weeks and received radiotherapy within 4 weeks before apheresis.
5. Patients with any organ dysfuntion as defined below:
* leukocytes\<3.0 x 109/L
* 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%
6. 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.
7. 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.
8. Left Ventricular Ejection Fractions (LVEF) \<50%.
9. Patient with a known active brain metastases.
10. Patient with a known myelodysplastic syndrome (MDS) or lymphoma.
11. 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.
12. Patient with a known active Hepatitis B or Hepatitis C.
13. Patient with a history of Human Immunodeficiency Virus (HIV) .
14. Patient with a history of syphilis.
15. Pregnant or lactating women.
16. Patient with a known active mental and neurological diseases.
17. The principal investigator judged that it is not suitable to participate in this clinical study.
18 Years
65 Years
ALL
No
Sponsors
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Corregene Biotechnology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CRTE7A2-2107C
Identifier Type: -
Identifier Source: org_study_id
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