CD123/CLL1 CAR-T Cells for R/R AML (STPHI_0001)

December 29, 2019 updated by: Jianda Hu, Fujian Medical University

CD123/CLL1 CAR-T Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia

The treatment options for relapse/refractory B-cell acute myeloid leukemia(AML)are limited.CD123/CLL1 CAR-T Cells may have a permanent anti-tumor effect and became very attractive. This study aims to assess the safety and toxicity of CD123/CLL1 CAR-T Cells to patients with relapse/refractory AML.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent
  • Aged < 70 years
  • Patients with relapsed/refractory AML
  • Cardiac: Left ventricular ejection fraction ≥ 50%
  • Adequate renal and hepatic function
  • Performance status: Karnofsky ≥ 70%

Exclusion Criteria:

  • Pregnant or lactating females.
  • Any co-morbidity precluding the administration of CD123/CLL1 CAR-T Cells.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
CD123/CLL1 CAR-T Cells treat
Biological: CD123/CLL1 CAR-T Cells
CD123/CLL1 CAR-T Cell Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Leukemia free survival
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events that are related to treatment
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 10, 2018

Primary Completion (Anticipated)

August 10, 2021

Study Completion (Anticipated)

August 10, 2021

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 13, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 29, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • CART-19-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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