NK Cell Therapy for AML - Trial NCT05256277
Access comprehensive clinical trial information for NCT05256277 through Pure Global AI's free database. This Phase 1 trial is sponsored by Zhejiang University and is currently Not yet recruiting. The study focuses on AML. Target enrollment is 18 participants.
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Study Focus
Sponsor & Location
Zhejiang University
Timeline & Enrollment
Phase 1
Dec 28, 2021
Jun 28, 2025
Primary Outcome
DLT/MTD
Summary
This is a single-arm, open-label, non-randomized, multiple-dose, phase 1 dose escalation
 study evaluating the safety, efficacy and PK of CT101a in patients with relapsed/refractory
 acute myeloid leukemia.
 
 Primary Objective:
 
 To evaluate the safety and tolerability of CT101a and estimate the MTD in Chinese patients.
 
 Secondary Objective:
 
 To determine the preliminary efficacy of CT101a in the treatment of r/r AML by IWG response
 rate; To determine the duration of response, time to progression, disease-free survival, and
 overall survival of AML patients treated with CT101a.
 
 Exploratory Objective:
 
 To investigate and analyze the correlation between the donor KIR gene and the efficacy in the
 subject.
 
 To explore the feasibility and safety of multiple doses of CT101a in the treatment of r/r
 AML.
 
 To detect blood samples and bone marrow samples before and after CT101a infusion by single
 cell sequencing method, and to perform difference analysis.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05256277
Non-Device Trial