Safety and Efficacy of CD123-Targeted CAR-T Therapy for Relapsed/Refractory Acute Myeloid Leukemia

STATUS

Recruiting
participants needed

40
sponsor

Chongqing Precision Biotech Co., Ltd

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Updated on 19 February 2024

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Summary

This is a single arm study to evaluate the efficacy and safety of CD123-targeted CAR-T cells therapy for patients with relapsed/refractory Acute Myeloid Leukemia.

Description

There are limited options for treatment of relapse/refractory Acute Myeloid Leukemia. CD123 is expressed on most myeloid leukemia cells so it is an 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 relapsed/refractory Acute Myeloid Leukemia. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.

Details

Condition	leukemia, Acute myeloid leukemia, Acute myeloid leukemia, Myeloid Leukemia
Age	3years - 75years
Treatment	CD123 CAR-T cells
Clinical Study Identifier	NCT04272125
Sponsor	Chongqing Precision Biotech Co., Ltd
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Signed written informed consent
	Diagnose as relapsed /refractory acute myeloid leukemia, and meet one of the following
	conditions
	Failed to standard chemotherapy regimens
	Relapse after complete remission, high-risk and / or refractory patients
	Relapse after hematopoietic stem cell transplantation
	Evidence for cell membrane CD123 expression
	All genders, ages: 3 to 75 years
	The expect time of survive is above 12 weeks
	KPS60
	No serious mental disorders
	Left ventricular ejection fraction 50%
	Sufficient hepatic function defined by ALT/AST3 x ULN and bilirubin2 x ULN
	Sufficient renal function defined by creatinine clearance2 x ULN
	Sufficient pulmonary function defined by indoor oxygen saturation92%
	With single or venous blood collection standards, and no other cell collection contraindications
	Ability and willingness to adhere to the study visit schedule and all protocol requirements
Exclusion Criteria
	Have received CAR-T therapy or other genetically modified cell therapy before screening
	Participated in other clinical research within 1 month before screening
	Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment
	Live attenuated vaccine within 4 weeks before screening
	Convulsion or stoke within past 6 months
	Previous history of other malignancy
	Presence of uncontrolled active infection
	Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive
	Pregnant or breasting-feeding women
	Any situation that investigators regard not suitable for attending in this study or may affect the data analysis

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Step 4 Get your study results

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Safety and Efficacy of CD123-Targeted CAR-T Therapy for Relapsed/Refractory Acute Myeloid Leukemia