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Trial record 1 of 1 for:    CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers
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CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05122221
Recruitment Status : Recruiting
First Posted : November 16, 2021
Last Update Posted : June 28, 2022
Information provided by (Responsible Party):
Corregene Biotechnology Co., Ltd

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Drug: 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.

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.

Primary Outcome Measures :
  1. MTD [ Time Frame: 28 days ]
    Maximum Tolerated Dose

  2. DLT [ Time Frame: 28 days ]
    Dose-limiting toxicity

  3. RP2D [ Time Frame: 28 days ]
    Recommended Phase II Dose

  4. Incidence of treatment related AEs, AEs of special interest and serious adverse events (SAEs). [ Time Frame: 2 years ]
    grade 1-5 (CTCAE)

Secondary Outcome Measures :
  1. Objective Response Rate(ORR) [ Time Frame: 2 years ]
    Assessed by RECIST 1.1

  2. Disease Control Rate(DCR) [ Time Frame: 2 years ]
    Assessed by RECIST 1.1

  3. Duration of Response(DOR) [ Time Frame: 2 years ]
    Assessed by RECIST 1.1

  4. Progression-Free Survival(PFS) [ Time Frame: 2 years ]
    Assessed by RECIST 1.1

Other Outcome Measures:
  1. Peripheral blood TCR-T cell copy number [ Time Frame: 2 years ]
  2. Negative conversion rate among HPV-16 positive patients detected by tissue biopsy [ Time Frame: 2 years ]

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥18 years and ≤65 years.
  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:

  1. The proportion of T cell immune-related gene deletion mutations>5%.
  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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT05122221

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Contact: Sa Wang, Master 8610-86464526-840

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China, Henan
The First Affiliated Hospital of Zhengzhou University Recruiting
Zhengzhou, Henan, China, 450052
Contact: Yi Zhang, Doctor    0371-66295320   
Principal Investigator: Yi Zhang, Doctor         
Sponsors and Collaborators
Corregene Biotechnology Co., Ltd
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Responsible Party: Corregene Biotechnology Co., Ltd Identifier: NCT05122221    
Other Study ID Numbers: CRTE7A2-2107C
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

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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
Keywords provided by Corregene Biotechnology Co., Ltd:
3+3 dose escalation
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Anus Neoplasms
Neoplasms by Site
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Anus Diseases
Rectal Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents