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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04265963
Other study ID # PBC011
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date September 1, 2019
Est. completion date July 1, 2024

Study information

Verified date March 2023
Source Chongqing Precision Biotech Co., Ltd
Contact Zhi Yang, PhD
Phone 86-13206140093
Email yangzhi@precision-biotech.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

There are limited options for treatment of relapse/refractory acute myeloid leukemia (AML). CD123 CAR-T cells may have an attractive and permanent effect on anti-tumor. This study purpose to estimate the safety and efficiency of CD123 CAR-T cells to patients with relapse/refractory AML.


Description:

CD123 is expressed on most myeloid leukemia cells so it is a ideal target for CAR-T. Some researches have revealed that CD123 is a marker of leukemia stem cells, which indicates that the eradication of CD123 cells may prevent relapse of leukemia. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD123 in patients with Acute Myelocytic Leukemia. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 45
Est. completion date July 1, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 75 Years
Eligibility Inclusion Criteria: 1. Signed written informed consent; 2. Diagnose as Relapsed/Refractory AML, and meet one of the following conditions: 1. With persistent disease after at least two lines of therapy; 2. Relapse to the last line of therapy in 6 months,as known as early recurrence; 3. Relapse to the last line of therapy after 6 months, but refractory to this last line of therapy; 4. Relapse more than once. The definition of relapse: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR (the most common are CNS and testicular leukemia). 3. Evidence for cell membrane CD123 expression; 4. KPS>60; 5. The expect time of survive is above 3 months; 6. Ages: 2 to 75 years; 7. All genders; 8. The patients that diagnosis as high risks, relapse/refractory or inconformity criteria to other therapy; 9. No serious mental disorders; 10. Left ventricular ejection fraction =40%; 11. Sufficient hepatic function defined by ALT/AST<5 x ULN and bilirubin=34.2µmol/L; 12. Sufficient renal function defined by creatinine clearance <220µmol/L; 13. Sufficient pulmonary function defined by indoor oxygen saturation=92%; 14. No other illness may conflict with the protocol (e.g. autoimmune diseases, immune deficiency and organ transplantation; 15. Ability and willingness to adhere to the study visit schedule and all protocol requirements. Exclusion Criteria: 1. Previous history of other malignancy; 2. Presence of uncontrolled active infection; 3. Evidence of disorder that need the treatment by glucocorticoids; 4. Active or chronic GVHD; 5. The patients treatment by inhibitor of T cell; 6. Pregnant or breasting-feeding women; 7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CD123 CAR-T cells
CD123 CAR-T cell therapy

Locations

Country Name City State
China 920th Hospital of Joint Logistics Support Force Kunming Yunnan

Sponsors (1)

Lead Sponsor Collaborator
Chongqing Precision Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events that related to treatment Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0). 2 years
Primary The response rate of CD123 CAR-T treatment in patients with relapse/refractory AML that treatment by CD123 CAR-T cells therapy The response rate of CD123 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline. 2 years
Secondary Cellular kinetics of CD123 CAR-T in Blood In vivo (peripheral blood) rate and quantity of CD123 CAR-T cells were determined by means of flow cytometry and qPCR 2 years
Secondary Cellular kinetics of CD123 CAR-T in Bone marrow In vivo (bone marrow) rate and quantity of CD123 CAR-T cells were determined by means of flow cytometry and qPCR 2 years
Secondary Cellular kinetics of CD123 positive cells in Bone marrow In vivo (bone marrow) rate and quantity of CD123 positive cells were determined by means of flow cytometry 1 years
Secondary Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed AML DOR will be assessed from the first assessment of CR or CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored) 2 years
Secondary Progress-free survival(PFS) of CD123 CAR-T treatment in patients with refractory/relapsed AML PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored) 2 years
Secondary Overall survival(OS) of CD123 CAR-T treatment in patients with refractory/relapsed AML OS will be assessed from the first CAR-T cell infusion to death from any cause (censored) 2 years
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