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
See if I qualify
psychiatric disorder
remission
renal function
chemotherapy regimen
ejection fraction
stem cell transplantation
myeloid leukemia
cell transplantation
mental disorders
oxygen saturation
cancer chemotherapy
leukemia
renal function test
alt/ast
refractory acute myeloid leukemia (aml)
cellular therapy
acute myeloid leukemia
refractory aml

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 IdentifierNCT04272125
SponsorChongqing Precision Biotech Co., Ltd
Last Modified on19 February 2024

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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psychiatric disorder
remission
renal function
chemotherapy regimen
ejection fraction
stem cell transplantation
myeloid leukemia
cell transplantation
mental disorders
oxygen saturation
cancer chemotherapy
leukemia
renal function test
alt/ast
refractory acute myeloid leukemia (aml)
cellular therapy
acute myeloid leukemia
refractory aml

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