Protocol Details
Expanded Access of Adoptive Cellular Immunotherapy for Progressive Multifocal Leukoencephalopathy with Ex Vivo Generated JC-Virus Specific T-cells
This study is currently recruiting participants.
Summary
Number |
001878-N |
Sponsoring Institute |
National Institute of Neurological Disorders and Stroke (NINDS) |
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;
Neonates;
Pregnant Women |
Keywords |
JC-Virus Specific T-cells |
Recruitment Keyword(s) |
None |
Condition(s) |
Progressive Multifocal Leukoencephalopathy |
Investigational Drug(s) |
Allogeneic ex vivo generated JCV-specific T cells
|
Investigational Device(s) |
None |
Intervention(s) |
None |
Supporting Site |
National Institute of Neurological Disorders and Stroke |
Background:
Progressive multifocal leukoencephalopathy (PML) is an infection of the central nervous system caused by the JC (John Cunningham) virus. PML can develop in people with a weakened immune system, and it is often fatal. There are no approved treatments for this disease. Researchers want to test a new treatment that alters a person s own immune cells (T cells) to target the JC virus. These altered cells are called JC-virus-specific T cells (JCVST).
Objective:
To test JCVST in people with PML.
Eligibility:
Adults aged 18 and older with definite or probable PML.
Design:
Participants will be screened. They will have an imaging scan of their brain. They will have a lumbar puncture: A needle will be inserted into the lower spine to remove a sample of fluid from space around the spinal cord. These tests will be repeated during study visits.
Some participants may receive JCVST made from donated T cells; others may receive JCVST made from their own T cells. Those receiving treatment with their own cells will undergo leukapheresis: Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The cells will be altered in a lab to create JCVST.
Participants will receive JCVST through a vein in the arm. They will return for a follow-up visit after 28 days. If the treatment is helping them, they may have additional infusions every 28 days.
Participants will have follow-up visits every 3 months for 1 year after their last treatment.
Eligibility
INCLUSION CRITERIA:
-Actively progressing, clinically definite or probable PML (2013 AAN Consensus DiagnosticCriteria)
-Age 18 or older
-Patient medically stable and able to tolerate travel to NIH
-Available eligible donor for JC-VST (autologous or allogenic) or available suitable cryopreserved JC-VST product with a minimum of 2/10 HLA-allele match
-Patients of childbearing or child-fathering potential must be willing to use a medically acceptable form of birth control while being treated on this study, (ie-hormonal contraception such as birth control pills, injected hormones and vaginal ring; intrauterine device; barrier methods with spermicide such as diaphragm and/or condom with spermicide; or surgical sterilization such as hysterectomy, tubal ligation or vasectomy.
-Willing and able to participate in all aspects of trial design and follow-up
-Able to provide informed consent at the time of study enrollment (not required for reinfusions)
EXCLUSION CRITERIA:
-Patients with readily reversible immunosuppressed state
-Patients with other uncontrolled infections. For bacterial infections, patients must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections, patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment.
-Patients with other active CNS disease that might negatively impact clinical outcome
-Patients with contraindication to MRI (including cardiac pacemakers and some infusion pumps, other metallic implants, metallic foreign objects)
-MRI findings consistent with immune system reconstitution inflammatory syndrome (IRIS) and determined to be mounting an adequate immune response to the JCV infection
-For patients who have previously received VST infusions, any treatment-limiting toxicity to previous infusions
-Patients with a positive pregnancy test or who are nursing.
Citations:
Not Provided
Contacts: