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Phase I Clinical Trial of RC1012 Injection in Patients With r/r AML

NCT05471323 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-05-19

No results posted yet for this study

Summary

To evaluate the safety and tolerability of RC1012 infusion in patients with relapsed or refractory Acute Myelocytic Leukemia (r/r AML).

Conditions

Interventions

BIOLOGICAL

RC1012 injection (allo-DNT cells)

RC1012 injection (allo-DNT cells) from healthy donors and have been proved to be safe and demonstrated potent cytotoxicity against AML blasts from AML patients in preclinical and preliminary clinical studies. Allo- DNT cells will be collected from healthy donors (NO MHC match needed) and injected into patients. The drug for this study is an off-the-shelf product. Patients DO NOT need to wait for the cell manufacturing.

Sponsors & Collaborators

  • First Affiliated Hospital of Zhejiang University

    collaborator OTHER

  • Guangdong Ruishun Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhen Cai, MD, PhD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2021-01-14
Primary Completion
2023-12-31
Completion
2024-12-31

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 NCT05471323 on ClinicalTrials.gov