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

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

Sponsors

Lead Sponsor: Chongqing Precision Biotech Co., Ltd

Source Chongqing Precision Biotech Co., Ltd
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date 2019-12-01
Completion Date 2023-07-01
Primary Completion Date 2022-12-30
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Adverse events that related to treatment 2 years
The response rate of CD123 CAR-T treatment in patients with relapse/refractory Acute Myeloid Leukemia that treatment by CD123 CAR-T cells therapy 6 months
Secondary Outcome
Measure Time Frame
Rate of CD123 CAR-T cells in bone marrow and peripheral blood 2 years
Quantity of CD123 CAR copies in bone marrow and peripheral blood 2 years
Cellular kinetics of CD123 positive cells in bone marrow 1 years
Levels of cytokines in serum 3 months
Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia 2 years
Progress-free survival(PFS) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia 2 year
Overall survival(OS) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia 2 years
Enrollment 40
Condition
Intervention

Intervention Type: Biological

Intervention Name: CD123 CAR-T cells

Description: A single infusion of CD123-CAR-T cells will be administered intravenously

Arm Group Label: CD123 CAR-T cells treat

Eligibility

Criteria:

Inclusion Criteria: 1. Signed written informed consent; 2. Diagnose as relapsed /refractory acute myeloid leukemia, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory patients ; 3. Relapse after hematopoietic stem cell transplantation; 3. Evidence for cell membrane CD123 expression; 4. All genders, ages: 3 to 75 years; 5. The expect time of survive is above 12 weeks; 6. KPS>60; 7. No serious mental disorders ; 8. Left ventricular ejection fraction ≥50% 9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN; 10. Sufficient renal function defined by creatinine clearance≤2 x ULN; 11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%; 12. With single or venous blood collection standards, and no other cell collection contraindications; 13. Ability and willingness to adhere to the study visit schedule and all protocol requirements. Exclusion Criteria: 1. Have received CAR-T therapy or other genetically modified cell therapy before screening; 2. Participated in other clinical research within 1 month before screening; 3. 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; 4. Live attenuated vaccine within 4 weeks before screening; 5. Convulsion or stoke within past 6 months; 6. Previous history of other malignancy; 7. Presence of uncontrolled active infection; 8. 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; 9. Pregnant or breasting-feeding women; 10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.

Gender:

All

Minimum Age:

3 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Overall Contact

Last Name: Zhi Yang, PhD

Phone: 86-13206140093

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Chongqing University Cancer Hospital Cheng Qian, PhD [email protected] Cheng Qian, PhD Principal Investigator Ying Xiang, MD Principal Investigator
Location Countries

China

Verification Date

2021-03-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: CD123 CAR-T cells treat

Type: Experimental

Description: Patients will be be treated with CD123 CAR-T cells

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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