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Study of Anti-CD33/CLL1 CAR-NK in Acute Myeloid Leukemia

NCT05215015 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-01-31

No results posted yet for this study

Summary

This is an open-label, nonrandomized, investigator-initiated clinical trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of anti-CD33/CLL1 CAR-NK cell injection in patients with acute myeloid leukemia (AML), and to determine PK parameters, maximum tolerated dose (MTD), and phase II recommended dose (RP2D) for subjects receiving CAR-NK cell injection.

Conditions

Interventions

BIOLOGICAL

Anti-CD33/CLL1 CAR-NK Cells

The administration of CAR-NK cells will be performed on day 1 and day 3 of each cycle (28 days). The first administration dose in the first cycle is 2.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 3.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 3.0×10\^9 cells.

Sponsors & Collaborators

  • Imbioray (Hangzhou) Biomedicine Co., Ltd.

    collaborator INDUSTRY

  • Wuxi People's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2022-11-30
Completion
2022-11-30

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 NCT05215015 on ClinicalTrials.gov