A Trial to Evaluate the Safety and Efficacy of NK Cells in Subjects With Myelodysplastic Syndromes

Early Phase 1

Not yet recruiting

• Conditions: Relapsed / Refractory Myelodysplastic Syndromes
• Interventions: Drug: NCR300

• Registration Number: NCT05371730
• Lead Sponsor: Nuwacell Biotechnologies Co., Ltd.

Brief Summary

A clinical study to Evaluate the Safety and Efficacy of NK cells in the treatment of Myelodysplastic Syndromes

Detailed Description

This is a single arm, open-label, single-center pilot study. In this study, 15 patients will be enrolled. The primary purpose is to explore the safety including incidence of adverse events and serious adverse events.The secondary purpose is to explore the efficacy.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-07
• Study First Submitted QC: 2022-05-07
• Last Update Submitted: 2022-05-07
• Study First Posted: 2022-05-12
• Last Update Posted: 2022-05-12
• Study Start: 2022-05-30
• Primary Completion: 2025-05-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NK cells	NCR300	-

Primary Outcome Measures

Name	Time	Method
AE or SAE	From infusion day 365	The incidence of AE or SAE of NK cells infusion

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	58 days after initial infusion	ORR (sum of CR and PR) after NK cells infusions
Bone Marrow Morphology	58 days after initial infusion	The proportion of bone marrow blasts after NK cells infusions.