A PHASE 1/2a, STUDY OF SAFETY, TOLERABILITY, PHARMACOKINECTS AND PHARMACODYNAMICS OF CDK-003 (exoIL-12) IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA (CTCL) (Part B)

  • STATUS
    Not Recruiting
  • End date
    Jan 13, 2024
  • participants needed
    30
  • sponsor
    Codiak BioSciences
Updated on 14 September 2022
platelet count
renal function
hysterectomy
lymphoma
measurable disease
bilateral oophorectomy
neutrophil count
cutaneous t-cell lymphoma

Summary

This is a Phase 1, dose escalation study to assess the safety, tolerability, pharmacokinetic and pharmacodynamic effects of CDK-003. The study is performed in two parts: Part A is a randomized, double-blind, placebo-controlled, single ascending dose study of CDK-003 in healthy adult male participants, and Part B is a single arm, open-label, multiple ascending dose in patient-participants with CTCL. Dose escalation in the study will only occur after satisfactory review of all available predefined data by the Safety Review Committee. Part A is complete and this entry describes Part B only.

Details
Condition Cutaneous T-cell Lymphoma (CTCL)
Treatment CDK-003
Clinical Study IdentifierNCT05156229
SponsorCodiak BioSciences
Last Modified on14 September 2022

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