CDX-301: Clinical Program
CLINICAL PROGRAM FOR TREATMENT OF CANCER PATIENTS REQUIRING HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT)
CDX-301 is soluble, recombinant human Fms-like tyrosine kinase-3 ligand (Flt3L) that acts by uniquely binding Fms-like tyrosine kinase-3 (Flt3, CD135) which is expressed on hematopoietic stem cells (HSC), early progenitor cells, immature thymocytes, and steady state dendritic cells, resulting in the proliferation, differentiation, development and mobilization of these cells in the bone marrow, peripheral blood, and lymphoid organs. Prior development of this program was performed by Immunex, Inc. demonstrating the safety and biologic activity in early clinical studies. A Phase 1 trial in healthy volunteers is underway to support subsequent trials for allogeneic HSCT. Celldex will eventually pursue additional indications potentially to include cancer therapy, ex vivo expansion of dendritic cells for cancer immunotherapy, radiation countermeasures, and burn management.
| Now Enrolling | |
| A Phase 1 Safety, Pharmacokinetic, and Immunologic Study to Evaluate CDX-301 (rhuFlt3L) in Healthy Volunteers | |
| Design: | Phase 1, open-label, dose-escalating study of CDX-301 |
| Status: | Currently enrolling |
About the Clinical Trial
CDX-301 is a protein that stimulates the growth of bone marrow stem cells and certain immune cells. This study is testing CDX-301 in healthy volunteers who will be monitored for safety and biological response for approximately one month or more. A total of seven cohorts of healthy volunteers are planned with doses of CDX-301 (rhuFlt3L) ranging between 1 and 75 μg/kg and dosing durations between 5 and 10 days. Volunteers will be admitted to an inpatient unit during the Treatment Period. Blood samples will be collected periodically to assess the effect of CDX-301. Volunteers will be followed for safety for 28 days following the last dose. Any volunteer who develops anti-CDX-301 antibodies will be followed monthly until the antibody response is below the limit of detection. In general, the total duration of the study will be between approximately 33-38 days.
Patient Eligibility
Among other criteria, volunteers must meet all of the following conditions to be eligible to be in the study:
- 18 years to 55 years
- Body Weight ≤ 120 kg or 265 lbs
- Generally good health and without significant medical conditions
- Willing to use effective method of contraception
- Abstinence from alcohol for 72 hours prior to study drug administration and throughout the study
- Negative screening test for HIV, hepatitis B, and hepatitis C
- Provide written informed consent
Among other criteria, volunteers who meet any of the following conditions are NOT eligible to be in the study:
- Drug or alcohol abuse within 12 months
- Positive drug screen
- Receipt of certain types of experimental drugs or other treatments, or certain medications
- Use of systemic immunosuppressive agents (excluding topical steroids) within 12 months
- History of certain diseases including syphilis, herpes zoster, primary or secondary immunodeficiency
- Diagnosis with or family history of significant autoimmunity (ex: type I diabetes, multiple sclerosis, rheumatoid arthritis, scleroderma)
- Any history of cancer, excluding adequately treated and cured basal or squamous cell carcinoma of the skin, or cervical carcinoma in situ within 2 years
- History of asthma requiring any use of inhaled or oral medication within 5 years
- Herpes zoster within 3 months
- Donation of blood within 8 weeks, and donation of plasma within 2 weeks
Please click here for more information about this trial, including clinical trial site and contact information for prospective volunteers.
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