Study Evaluating Safety and Efficacy of CAR-T Cells Targeting CD123 in Patients With Acute Myelocytic Leukemia

NCT03796390 | Unknown Phase 1

• 1 other identifier: Daopei CD123CAR-T
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 Leukemia. A total of 15 patients are planned to be enrolled following up one year.

Conditions

Acute Myelocytic Leukemia

Keywords

AML，CD123

Outcome Measures

Primary Outcomes (1)

• Tumor load

  Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis.

  Up to 12 months

Secondary Outcomes (1)

• CAR-T cell persistence

  Up to 12 months

Study Arms (1)

CD123 CAR-T cells

EXPERIMENTAL

Patients will be be treated with CD123 CAR-T cells

Biological: CD123 CAR-T cells

Interventions

CD123 CAR-T cells BIOLOGICAL

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.

CD123 CAR-T cells

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \) 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.
• \. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead
• Hebei Yanda Ludaopei Hospital: collaborator

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Langfang, Hebei, 065000, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Peihua Lu, PhD&MD

  Hebei Yanda Ludaopei Hospital

  STUDY CHAIR

Central Study Contacts

Peihua Lu, PhD&MD

CONTACT

008618611636172; peihua_lu@126.com

Jianqiang Li, PhD&MD

CONTACT

008615511369555; limmune@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: December 26, 2018
• Primary Completion: November 6, 2020
• Study Completion: June 6, 2021
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

CN (1)