First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients

About this trial

Last updated 4 years ago

Study ID

XT-1901

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Accepting

18 to 65 Years

All Sexes

Trial Timing

Ended 4 years ago

What is this trial about?

This first in human study aims at evaluating LIS1, a stabilized solution of purified anti-T lymphocytes polyclonal glyco-humanized swine IgG with immunosuppressive activity, in regards of safety, T cell depletion, and pharmacokinetics / pharmacodynamics in 10 kidney transplant recipients.

What are the participation requirements?

Inclusion Criteria

* Participants must be listed for kidney transplantation,

* AD cohort participants: First transplantation, Panel Reactive Antibody (PRA) < 20%, negative Donor Specific Antibody (DSA), no anti-HLA antibodies, Epstein-Barr Virus positive (EBV+) serology,

* TD cohort participants: First transplantation, 0-50 % PRA, negative DSA, negative flow cytometry crossmatch (FCXM) for any patients with anti-HLA antibodies on screening is mandatory, Epstein-Barr Virus positive (EBV+) serology

* Participants must weigh at least 50 kg and have a Body Mass Index (BMI) 18.0 ≤ BMI < 35.0 kg/m2,

* White Blood Cells > 3000/mm3, platelets > 75000/mm3,

* Female participants (WOCBP) must have a negative pregnancy test at screening and use a highly effective birth control until 90 days after the last administration of study drug,

* Non-vasectomized male subjects having a female partner of childbearing potential must agree to the use of a highly effective method of contraception until 90 days after the last administration of study drug,

* Participants must be capable of giving signed informed consent.

Exclusion Criteria

* Patients with an active cancer or a history of kidney cancer,

* Patients who have previously been exposed to other anti-lymphocyte globulins,

* Patients with previous organ transplantation,

* Patients with a history of specific viral infection that would contraindicate depleting antibody therapy (Hepatitis B and C, HIV),

* Patients with a positive HIV and/or Hepatitis B and C tests

* Patients who have uncontrolled concomitant bacterial or viral infections (unresolved during screening), mycosis and/or parasitosis,

* Patients with a significant liver function impairment: enzyme (AST and/or ALT) values must not exceed 1.5 times upper limit of normal,

* Patients with positive testing for tuberculosis (using QuantiFERON-TB test), Patients with CMV D+/R- constellation at transplant,

* Patients with seronegative EBV prior to transplantation,

* Patients who have previously been exposed to antibodies of swine origin,

* Expanded Criteria Donor (ECD) defined as donor older than 60 years,

* Participants who have participated in another research study involving an investigational product in the previous 3 months,

* Patients with cardiovascular or severe respiratory comorbidities (severe chronic respiratory failure, severe pulmonary fibrosis, obesity-ventilation syndrome, severe idiopathic pulmonary arterial hypertension) not allowing general anesthesia,

* Patients with type 1 diabetes,

* Participants who are pregnant, breast feeding or planning pregnancy during the study,

* Participants who have any form of substance abuse (drug, alcohol…), any other health abnormalities (psychiatric disorders) or condition that according to the investigator's opinion might endanger patient during his/her participation in the study.