Clinical Trial for the Safety and Efficacy of CD 70 CAR T for Patients With CD70 Positive Malignant Hematologic Diseases
A Study of CD 70 CAR T for patients with CD70 positive malignant hematologic diseases
• Histologically confirmed diagnosis of CD70 AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
• Relapsed or refractory CD70+ AML (meeting one of the following conditions):
‣ CR not achieved after standardized chemotherapy;
⁃ CR achieved following the first induction, but CR duration is less than 12 months;
⁃ Ineffectively after first or multiple remedial treatments;
⁃ 2 or more relapses;
• The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
• No gender and age limit;
• Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
• Relapsed or refractory CD70+ NHL (meeting one of the following conditions):
‣ No response or relapse after second-line or above chemotherapy regimens;
⁃ Primary drug resistance;
⁃ Relapse after auto-HSCT;
• At least one assessable tumor lesion per Lugano 2014 criteria
• Histologically confirmed diagnosis of CD70 multiple myeloma (MM):
‣ According to the diagnostic criteria of IMWG multiple myeloma, the diagnosis was recurrent / refractory multiple myeloma
⁃ Cases with recurrent positive minimal residual disease;
⁃ Extramedullary leision which is hard to be eradicated by chemotherapy or radiotherapy.
• No gender and age limit;
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
• No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.
∙ Common inclusion criteria :
• Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
• Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
• No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 2;
• Patients or their legal guardians volunteer to participate in the study and sign the informed consent -