NCT05256277

NK Cell Therapy for AML

A Phase 1 Study of Evaluating Preliminary Safety and Efficacy of CT101a in the Treatment of Relapsed or Refractory (r/r) AML Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 AML. This clinical study is to evaluate the safety, MTD and preliminary efficacy of CT101a in patients with relapsed/refractory AML. Up to 9-18 patients will be enrolled.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	CT101a	cytokine-induced memory-like NK cells

Timeline

• Start date: 2021-12-28
• Primary completion: 2022-08-28
• Completion: 2023-04-03
• First posted: 2022-02-25
• Last updated: 2023-05-16

Locations

1 site across 1 country: China