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NK Cell Therapy for AML

NCT05256277 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-05-16

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CT101a

cytokine-induced memory-like NK cells

Sponsors & Collaborators

  • Shanghai Zeke Biotechnology Co.，Ltd

    collaborator UNKNOWN

  • Zhejiang University

    lead OTHER

Principal Investigators

  • Huang He, PhD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2022-08-28
Completion
2023-04-03

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05256277 on ClinicalTrials.gov