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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03578406
Other study ID # XQDC20180520
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 1, 2018
Est. completion date August 30, 2021

Study information

Verified date April 2019
Source Xinqiao Hospital of Chongqing
Contact Qingzhu Jia
Phone +8615223334184
Email jiaqingzhu0801@outlook.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Human papillomavirus infections 16 (HPV16) is known to be a high-risk factor to induce cervical cancers. To date, HPV16-related cervical cancer is still a major concern in developing countries where vaccination is not prevalent. Concurrent therapies for cervical cancers have limited response rate and high chance of relapse. However, HPV16-induced cancers provided an ideal target for T cell-based immunotherapy due to the non-self origins. Engineered T cells bearing a TCR (TCR-T) that can specifically recognize the presented HPV antigen become a viable approach to treat this type of cancer. Though engineered T therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. One key mechanism of tumor-elicited suppression is the PDL1-PD1 interaction which induces T cell exhaustion. Therefore, TCR-T cells armed with a PD1 antagonist could further enhance the efficacy of TCR-T in solid cancers.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 30, 2021
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Expected to live longer than 12 weeks

- PS 0-2

- Pathology confirmed as HPV16 positive malignant tumor, either metastatic or recurrent disease

- Creatinine <2.5mg/dl

- ALT/AST is lower than three times ULN.

- No contraindications of leukocyte collection

- Before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion.

- Understand this trial and have signed an informed consent

Exclusion Criteria:

- Patients with symptomatic brain metastasis

- With other uncontrolled malignant tumors.

- Hepatitis B or Hepatitis C activity period, HIV infected patients

- Any other uncontrolled disease that interferes with the trial

- Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage

- Untreated hypertension or hypertensive patients

- A person with a history of mental illness that is difficult to control

- Researchers do not consider it appropriate to participate in this trial

- Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids

- Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment

- An illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HPV E6-specific TCR-T cells
Patients were infused with HPV E6-specific TCR-T cells

Locations

Country Name City State
China Qingzhu Jia Chongqing Chongqing

Sponsors (2)

Lead Sponsor Collaborator
Xinqiao Hospital of Chongqing TCRCure Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary To Determine the Maximum Tolerated Dose Verify the MTD of TCR-T cells for HPV16 E6 antigen for treatment. Nine patients will be enrolled in this project, using a dose-climbing approach, with every three patients as a group. The first group of patients returned to 5x106/kg TCR-T cells, the second group returned to 1x107/kg TCR-T cells, and the third group returned to 5x107/kg TCR-T cells 8 weeks
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