AML
Conditions
Brief summary
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML
Detailed description
Assessment of the Safety and Feasibility of Administering T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor to Patients With CD123+ AML and determine the best dosage.
Interventions
DRUGIM23
T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor
Sponsors
Beijing Immunochina Medical Science & Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with CD123+ Refractory or Relapsed AML * To be aged 3 to 80 years * Expression of CD123 in Blast ≥90% * ECOG score ≤2 * Voluntary participation in the clinical trials and sign the informed consent.
Exclusion criteria
* Intracranial hypertension or unconsciousness * Respiratory failure * CD19 negative * Disseminated intravascular coagulation * ALT /AST\>3 x normal value; Creatinine\> 1.5 x normal value; Bilirubin \>2.0 x -normal value * Hematosepsis or Uncontrolled active infection * Uncontrolled diabetes * Abalienation; * Patients in pregnancy or breast-feeding period * Previously treatment with any gene therapy products * Any uncontrolled medical disorders that the researchers consider are not eligible to participate the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of study related adverse events | 2 years | defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2 |
Countries
China
Outcome results
None listed