Status and phase
Conditions
Treatments
About
This is an open label, phase I study to assess the safety and efficacy of CD33 CAR-T in patients with relapsed and refractory acute myeloid leukemia
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
The expression of CD33 in AML blast is positive ;
The patient has recovered from the toxicity of previous treatment;
ECOG score ≤ 2 and expected survival period is not less than 3 months;
Adequate organ function defined as:
AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
20 participants in 1 patient group
Loading...
Central trial contact
Mingming Zhang, MD; He Huang, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal