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

NCT ID: NCT03631576

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2021-08-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsed/Refractory AML

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1

CD123/CLL1 CAR-T Cells treat

Group Type EXPERIMENTAL

CD123/CLL1 CAR-T Cells

Intervention Type BIOLOGICAL

CD123/CLL1 CAR-T Cell Therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CD123/CLL1 CAR-T Cells

CD123/CLL1 CAR-T Cell Therapy

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jianda Hu

Director of the department of Hematology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jianda Hu, Prof.M.D.Ph.D

Role: CONTACT

86-13959169016

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jianda Hu, Prof.

Role: primary

86-13959169016

Ting Yang, Prof.

Role: backup

86-13950210357

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CART-19-04

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Off-the-shelf CD123 CAR-NK for R/R AML
NCT06201247 RECRUITING EARLY_PHASE1
Multiple CAR-T Cell Therapy Targeting AML
NCT04010877 UNKNOWN PHASE1/PHASE2