Status:
UNKNOWN
HPV Specific Immune Lymphocytes (HPV-CTLs) in the Treatment of HPV
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Human Papilloma Virus
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of IV-infused autologous or allogenic HPV-CTLs.
Detailed Description
Human papilloma viruses (HPV) have been consistently implicated in causing cervical cancer especially those high-risk types (HPV 16, 18, 31, 45). Around 50-80% of women are infected by HPV within thei...
Eligibility Criteria
Inclusion
- Written, informed consent obtained prior to any study-specific procedures.
- Evidence of HPV virus activation (viral DNA) or high risk of HPV infection.
- Not suitable for routine treatment or invalid to antiviral drugs.
- Patients with viral disease symptoms and confirmed by biopsy, regardless of the level of virus DNA.
- Age less than 75 years.
- Did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
- Initial hematopoietic reconstitution: neutrophils (ANC) ≥ 1,000/mm\^3, platelet (PLT) ≥ 1,000/mm\^3.
- Proper renal and hepatic functions (ULN denotes "upper limit of normal range"): Creatinine ≤ 2\*ULN, Bilirubin ≤ 2\*ULN, SGOT/ SGPT ≤ 3\*ULN.
- If HPV-CTL is not from the patient's own, then the provider of HPV-CTL needs to meet the following criteria:
- did not receive chemotherapy or radiotherapy within 4 weeks prior to blood collection, and did not take any steroids for the previous week, did not use Penicillin or β-lactam antibiotics, or the lowest dose of other antibiotics.
- white blood cells ≥ 3,500 / μl, lymphocytes ≥ 750 / μl.
- Human immunodeficiency virus (HIV) test was negative.
Exclusion
- Subject or the donor of BMT recipient infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
- Subject is albumin-intolerant.
- Subject with life expectancy less than 8 weeks.
- Subject participated in other investigational somatic cell therapies within past 30 days.
- Subject with positive pregnancy test result.
Key Trial Info
Start Date :
November 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03351855
Start Date
November 15 2017
End Date
December 31 2021
Last Update
September 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000