Status:
UNKNOWN
Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Myelocytic Leukemia
Lead Sponsor:
Hebei Senlang Biotechnology Inc., Ltd.
Collaborating Sponsors:
Hebei Yanda Ludaopei Hospital
Conditions:
Acute Myelocytic Leukemia
Eligibility:
All Genders
2-65 years
Phase:
PHASE1
Brief Summary
This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD123 in the treatment of Acute Myelocytic Leuke...
Detailed Description
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. Besides CD19, many o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 6 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03796390
Start Date
December 26 2018
End Date
June 6 2021
Last Update
January 11 2019
Active Locations (1)
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1
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, China, 065000