- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03796390
Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Myelocytic Leukemia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Hebei
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Langfang, Hebei, China, 065000
- Recruiting
- Hebei yanda Ludaopei Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:
- Diagnosed as recurrent or refractory acute myeloid leukemia
- Tumor cells confirmed CD123 positive by Flow cytometry (FCM) or immunohistochemical detection, and CD123 positive rate >80%
- Age ≥ 2 years old, and <65 years old
- Estimated survival time is longer than 3 months from the date of signing the informed consent form
- KPS ≥ 80 points
- Important organs function need to meet the following conditions:
1) EF>50%, and there is no obvious abnormality in ECG; 2) SpO2≥90%; 3)Cr≤2.5ULN; 4)ALT and AST≤4ULN, TBil≤50μmol/L 7. Subjects with a pregnancy plan must agree to take contraception before the enrollment study and after the study lasts for six months; if the subject is pregnant or suspects of pregnancy, the investigator should be notified immediately 8. Need to stop chemotherapy for at least 2 weeks before collecting the blood to manufacture CAR-T cells.
9. For allogeneic hematopoietic stem cell transplantation subjects, it is necessary to stop the immunosuppressant against GVHD for at least 2 weeks before collecting autologous blood preparation, and if the donor is preparing blood, it is of no influence; 10. If the subject has a history of central nervous system (CNS) leukemia, the tumor cells in the cerebrospinal fluid need to be cleared and the white blood cell count <5 * 10^6 / L ,then can proceed lymphodepletion 11. Subjects who participate in other studies must withdraw other studies for 2 weeks before they can be enrolled.
Exclusion Criteria:
- Combine other diseases not effectively controlled, including but not limited to persistent or poorly controlled infections, symptomatic congestive heart failure, unstable angina, arrhythmia, poorly controlled lung disease or mental illness
- There are other active malignant tumors
- Combined serious infection and can not be effectively controlled
- Active hepatitis (HBV DNA or hepatitis C virus ribonucleic acid [HCVRNA] detection positive)
- Human immunodeficiency virus (HIV) infection or syphilis infection
- Have a history of severe allergies in biological products (including antibiotics)
- One month after discontinuation of immunosuppressants, allogeneic hematopoietic stem cell transplantation patients still have acute graft versus host response (GvHD)
- Female subjects are pregnant or lactating
- Systemic administration of glucocorticoids within one week prior to CAR-T treatment
- In the past, there was a prolonged QT interval or severe heart disease.
- Active autoimmune diseases requiring systemic immunosuppressive therapy
- The investigator believes that it may increase the risk of the subject or interfere with the study results.
Exit criteria:
- The subjects request to withdraw from the study before CAR-T infusion
- The subjects seriously violate the protocol
- Before CAR-T infusion, the following indicators are still abnormal after treatment:
1) EF>50%, and there is no obvious abnormality in ECG 2) SpO2≥90% 3)Cr≤2.5ULN(the upper limit of normal ) 4) ALT and AST ≤ 4ULN, TBil ≤ 50μmol / L 4.Not enough T cells for manufacture standard CAR-T cells 5. Other serious adverse events occurred
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: CD123 CAR-T cells
Patients will be be treated with CD123 CAR-T cells
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Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing.
The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration.
Chemotherapy will then be given.
Following tumor burden reassessment, CD123 CAR-T cells will be infused.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumor load
Time Frame: Up to 12 months
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Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.
|
Up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CAR-T cell persistence
Time Frame: Up to 12 months
|
CAR-T cell persistence will be quantified with flow cytometry and qPCR; Percentage of CART cells in BM and copies of car per ug DNA
|
Up to 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Peihua Lu, PhD&MD, Hebei yanda Ludaopei Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Daopei CD123CAR-T
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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