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RecruitingNCT04272125Updated Apr 18, 2023

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

A Phase 1/2 interventional study of CD123 CAR-T cells in Leukemia, Leukemia, Myeloid and Leukemia, Myeloid, Acute, sponsored by Chongqing Precision Biotech Co., Ltd. Recruiting at 1 site in China. Open to participants aged 3 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Chongqing Precision Biotech Co., Ltd · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 9 months ago, but the record still lists the study as recruiting.
  • Started Dec 2019; still recruiting 6 years 10 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
3 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute

Keywords

  • Leukemia
  • Acute Myeloid Leukemia
  • CD123
  • CAR-T
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 40 is close to the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Chongqing Precision Biotech Co., Ltd is the lead sponsor of 51 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    CD123 CAR-T cells treat

    Patients will be be treated with CD123 CAR-T cells

    Biological: CD123 CAR-T cells

Interventions

  • BiologicalCD123 CAR-T cells

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 2 years

  2. The response rate of CD123 CAR-T treatment in patients with relapse/refractory Acute Myeloid Leukemia 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

    Time frame: 6 months

Secondary outcomes

  1. Rate of CD123 CAR-T cells in bone marrow and peripheral blood

    In vivo (bone marrow and peripheral blood) rate of CD123 CAR-T cells were determined by means of flow cytometry

    Time frame: 2 years

  2. Quantity of CD123 CAR copies in bone marrow and peripheral blood

    In vivo (bone marrow and peripheral blood) quantity of CD123 CAR copies were determined by means of qPCR

    Time frame: 2 years

  3. 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

    Time frame: 1 years

  4. Levels of cytokines in serum

    In vivo (serum) quantity of cytokines

    Time frame: 3 months

  5. Duration of Response (DOR) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia

    DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored)

    Time frame: 2 years

  6. Progress-free survival(PFS) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia

    PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)

    Time frame: 2 year

  7. Overall survival(OS) of CD123 CAR-T treatment in patients with refractory/relapsed acute myeloid leukemia

    OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • Chongqing University Cancer Hospital
    Chongqing, Chongqing, China
    • Cheng Qian, PhD · Contact · cqian3184@163.com
    • Ying Xiang, MD · Contact · 1324339678@qq.com
    • Cheng Qian, PhD · Principal investigator
    • Ying Xiang, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04272125
Lead sponsor
Chongqing Precision Biotech Co., Ltd
Responsible party
Sponsor
First posted
Feb 17, 2020
Start date
Dec 1, 2019
Primary completion
Dec 31, 2023 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Apr 18, 2023

Study contacts

Zhi Yang, PhD
Contact
yangzhi@precision-biotech.com
86-13206140093
Yingzi Zhang
Contact
yingzi6526@163.com
86-18623351275
Cheng Qian, PhD
principal investigator · Chongqing University Cancer Hospital
Ying Xiang, MD
principal investigator · Chongqing University Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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