A Phase I Study of CYT107 (Recombinant Glycosylated Human IL-7) in Recipients of HLA Matched Ex Vivo T Cell Depleted Bone Marrow or Peripheral Blood Stem Cell Transplant
Rationale: Delayed and deficient reconstitution of T cells and their functions are a major
obstacle to the success of a hematopoietic stem cell transplant (HSCT). CYT-107 may have
potential clinical use after allogeneic HSCT to enhance lymphoid reconstitution which could
have a number of beneficial effects including decreased morbidity and mortality from
post-transplant infections. Our preliminary data with a previous generation IL-7, CYT 99
007, raise the possibility that IL-7 could have, in some cases, an anti-GVHD effect while
keeping the anti-tumor effect of the allograft intact.
- To determine the safety and a recommended dose of CYT107 (r-hIL-7) in recipients of
an HLA-matched related or unrelated ex vivo T-cell-depleted bone marrow (BM) or
peripheral blood stem cell (PBSC) transplant after initial engraftment and
- If toxicities are encountered, to establish the maximum tolerated dose (MTD) and dose
limiting toxicities (DLT).
- To define the pharmacokinetics of escalating doses of CYT107 in recipients of
To achieve preliminary characterization:
- Of the effects of CYT107 treatment on engraftment and GVHD.
- Of the effects of CYT107 on the recovery of T, NK and B cell populations and their
functions in vitro.
- Of a tolerable biologically active range of doses for CYT107 in recipients of
- Whether and to what degree administration of CYT107 might influence the risk of
developing an EBV-lymphoproliferative disorder.
- Of the effects of CYT107 treatment on leukemia relapse.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicity of CYT107 in post-transplant patients with AML, CML and MDS using the NCI Common Toxicity Criteria version 3.0 with the BMT specific adverse event grading system.
Visits: 2 week screening period; treatment visits on days 0, 7, and 14; non-treatment visits on Days 1, 21, 28, 42, 56, and 77.
Marcel van den Brink, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Memorial Sloan-Kettering Cancer Institute||New York, New York 10065|