This study is currently recruiting participants.
Number
002206-I
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: 99 Years
Referral Letter Required
Yes
Population Exclusion(s)
Children;Fetuses;Pregnant Women;Neonates
Keywords
Autosomal recessive genetic deficiency of IL-7; Expanded Access; NT-I7
Recruitment Keyword(s)
None
Condition(s)
Autosomal recessive genetic deficiency of IL-7
Investigational Drug(s)
efineptakin alfa
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
Interleukin-7 (IL-7) is a protein that helps the immune system work correctly. Some people have a genetic defect that prevents their body from making IL-7. As a result, they are more likely to get infections. If people with this genetic defect have human papillomavirus (HPV), they can develop skin lesions that do not heal. The lesions could cause skin cancer. A synthetic version of IL-7 may help the body clear HPV lesions.
Objective:
To learn if a study drug (NT-17) can help clear HPV lesions in people whose bodies do not produce IL-7.
Eligibility:
People aged 18 years and older with a genetic defect that prevents IL-7 production. They must also have HPV lesions.
Design:
Participants will have up to 23 clinic visits in about 21 months.
NT-17 is injected into the muscle of the upper arm, thigh, or buttock. Participants will get up to 5 doses of NT-17 at the clinic. The first 3 doses are given about 3 months apart. The last 2 doses are given about 6 months apart.
The day before each injection, participants will have a physical exam, with blood tests and a test of their heart function. At 7 and 30 days after each injection, they will have an exam with blood tests. Photos may be taken of their HPV lesions. They may have a small piece of skin cut away (biopsy). The 30-day visit may be in person or by telehealth.
Three additional visits will occur after 9, 15, and 21 months of treatment.
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INCLUSION CRITERIA: In order to be eligible to participate in this EAP, an individual must meet all of the following criteria: 1. Aged 18 years and older. 2. Diagnosis of autosomal recessive genetic deficiency of IL-7. 3. Participants who can become pregnant or who can impregnate their partner must agree to remain abstinent or use 2 acceptable methods of contraception, at least 1 of which must be a barrier method, when engaging in sexual activities that can result in pregnancy, beginning at the first pre-injection visit until the 30 days after the final visit. Acceptable methods of contraception include the following: a. Male or female condom. b. Diaphragm or cervical cap with a spermicide. c. Hormonal contraception. d. Intrauterine device. Note: Contraception requirements do not apply to participants who are post-menopause (age >=45 years plus no menses for 12 consecutive months without an alternative medical cause). EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this EAP: 1. Known hypersensitivity to NT-I7 or any of its components. 2. Pregnant or breastfeeding. 3. Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that, in the opinion of the principal investigator, contraindicates participation. Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, or socioeconomic status, except for age.
In order to be eligible to participate in this EAP, an individual must meet all of the following criteria:
1. Aged 18 years and older.
2. Diagnosis of autosomal recessive genetic deficiency of IL-7.
3. Participants who can become pregnant or who can impregnate their partner must agree to remain abstinent or use 2 acceptable methods of contraception, at least 1 of which must be a barrier method, when engaging in sexual activities that can result in pregnancy, beginning at the first pre-injection visit until the 30 days after the final visit. Acceptable methods of contraception include the following:
a. Male or female condom.
b. Diaphragm or cervical cap with a spermicide.
c. Hormonal contraception.
d. Intrauterine device.
Note: Contraception requirements do not apply to participants who are post-menopause (age >=45 years plus no menses for 12 consecutive months without an alternative medical cause).
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this EAP:
1. Known hypersensitivity to NT-I7 or any of its components.
2. Pregnant or breastfeeding.
3. Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that, in the opinion of the principal investigator, contraindicates participation.
Participants will be selected in an equitable manner from the available pool of potentially eligible individuals, without regard to factors such as sex, gender, race, ethnicity, or socioeconomic status, except for age.
Principal Investigator
Referral Contact
For more information: