CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
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|ClinicalTrials.gov Identifier: NCT05122221|
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : June 28, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Anal Cancer Head and Neck Cancers||Drug: Fludarabine + Cyclophosphamide Drug: Interleukin-2 Biological: CRTE7A2-01 TCR-T Cell||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||July 17, 2022|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||December 2024|
Experimental: CRTE7A2-01 TCR-T cell therapy
Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2
Drug: Fludarabine + Cyclophosphamide
Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days
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.
Biological: 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.
- 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)
- Objective Response Rate（ORR） [ Time Frame: 2 years ]Assessed by RECIST 1.1
- Disease Control Rate（DCR） [ Time Frame: 2 years ]Assessed by RECIST 1.1
- Duration of Response（DOR） [ Time Frame: 2 years ]Assessed by RECIST 1.1
- Progression-Free Survival（PFS） [ Time Frame: 2 years ]Assessed by RECIST 1.1
- Peripheral blood TCR-T cell copy number [ Time Frame: 2 years ]
- Negative conversion rate among HPV-16 positive patients detected by tissue biopsy [ Time Frame: 2 years ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
- absolute neutrophil count >1.5 x 109/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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05122221
|Contact: Sa Wang, Masteremail@example.com|
|The First Affiliated Hospital of Zhengzhou University||Recruiting|
|Zhengzhou, Henan, China, 450052|
|Contact: Yi Zhang, Doctor 0371-66295320 firstname.lastname@example.org|
|Principal Investigator: Yi Zhang, Doctor|
|Responsible Party:||Corregene Biotechnology Co., Ltd|
|Other Study ID Numbers:||
|First Posted:||November 16, 2021 Key Record Dates|
|Last Update Posted:||June 28, 2022|
|Last Verified:||November 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
3+3 dose escalation
Head and Neck Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents