CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

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Brief Title

CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

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

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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

MTD

Secondary Outcome

 Objective Response Rate(ORR)

Condition

Cervical Cancer

Intervention

Fludarabine + Cyclophosphamide

Study Arms / Comparison Groups

 CRTE7A2-01 TCR-T cell therapy
Description:  Patients will undergo lymphocytapheresis, then treatment with TCR-T cell (at escalating doses) + IL-2

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

12

Start Date

December 2021

Completion Date

December 2024

Primary Completion Date

March 2023

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

, 8610-86464526-840, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT05122221

Organization ID

CRTE7A2-2107C


Responsible Party

Sponsor

Study Sponsor

Corregene Biotechnology Co., Ltd


Study Sponsor

, , 


Verification Date

November 2021