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

Second Affiliated Hospital of Xi'an Jiaotong University1 site in 1 country2 target enrollmentApril 17, 2019

ConditionsAcute Leukemia Acute Leukemia in Relapse Acute Myeloid Leukemia Relapsed or Refractory Acute Leukemia

Interventionsanti-CD123 CAR-T treatment

Drugsanti-CD123 CAR-T treatment

Overview

Phase: Phase 1
Intervention: anti-CD123 CAR-T treatment
Conditions: Acute Leukemia
Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Enrollment: 2
Locations: 1
Primary Endpoint: Dose-limiting toxicity (DLT)
Status: Terminated
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single arm, open-label, phase 1 study, to determine the safety and efficacy of anti-CD123 CAR-T cells in treating patients diagnosed with refractory/relapsed acute leukemia in a dose-escalation way.

Detailed Description

This is a dose-escalation study of autologous anti-CD123 CAR-T cells. Patients receive fludarabine phosphate(300 mg/m\^2) and cyclophosphamide (30 mg/m\^2) IV on days -5 to -3, and then Patients receive autologous anti-CD123 CAR T cells IV over 20 minutes on day 0 (20% of total dose), day2 (30% of total dose) and day6 (50% of total dose, according to the side-effects occured). The total dose of CAR-T cells used in dose-escalation study is 0.5x10\^6- 2.0x10\^6 CAR-T cells/kg.

Registry

clinicaltrials.gov

Start Date

April 17, 2019

End Date

July 31, 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Research patients enrolled are those patients with relapsed or refractory CD123+ acute leukemia (Acute Myeloid Leukemia/ acute lymphoblastic leukemia );
•Relapsed: is defined as patients that had a first complete remission (CR) before developing recurrent disease (increased bone marrow blasts);
•Refractory: is defined as patients that have not achieved a first CR after 2 cycles of induction chemotherapy; for patients with leukemia evolving from myelodysplastic syndrome, they should have completed at least one cycle of induction chemotherapy;
•Research participants must have bone marrow and/or peripheral blood samples available for confirmation of diagnosis; CD123 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry; cytogenetics, flow cytometry, and molecular studies (such as FMS-like tyrosine kinase-3 \[FLT-3\] status) will be obtained as per standard practice;
•Karnofsky performance status score \>= 70;
•Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately;
•Calculated creatinine clearance (absolute value) of \>= 50 mL/minute or creatinine \< 2.0 mg/dl or \< 2 times upper limit of normal for the research participant's age group;
•Serum bilirubin =\< 3.0 mg/dL;
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 5 times the institutional upper limits of normal;
•Ejection fraction measured by echocardiogram (ECHO) or multi gated acquisition scan (MUGA) \>= 50%;

Exclusion Criteria

•Acute Promyelocytic Leukemia, t(15,17) (q22;q12);
•Pregnant and lactating women;
•Research participants who have tested human immunodeficiency virus (HIV) positive, or have active hepatitis B or C infection, or poorly controlled infection;
•History of allergic reactions attributed to compounds of similar chemical or biological composition to cetuximab
•Dependence on corticosteroids (5mg/day prednisone more than 2 weeks);
•A known hypersensitivity to any of the test materials or related compounds;
•Presence of active and clinically relevant Central Nervous System (CNS) disorder;
•Undergone prior allogeneic stem cell transplant, GVHD occurred within 6 months, requiring immunosuppressive therapy;
•Active autoimmune disease, such as psoriasis and rheumatoid arthritis;
•Other situations the clinicians think not eligible for participation in the research.