This study is a single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population were patients with relapsed and refractory acute myeloid leukemia (r/r AML) .
Single-center clinical study. The main purpose is an IIT clinical trial to evaluate the safety and preliminary efficacy of CLL1 and CD38 dual CAR-T injection in r/r AML subjects . The included population was patients with relapsed and refractory acute myeloid leukemia (r/r AML) .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
CLL1 and CD38 dual-target CAR-T injection
920th Hospital of Joint LogisticsSupport Force of People's Liberation
Kunming, Yunnan, China
Dose limited toxicity (DLT);
Dose limited toxicity (DLT);
Time frame: 28 days after CAR-T infusion
Adverse events (AE)
• Adverse events (AE): CTCAE version 5.0 standards will be used for rating
Time frame: 48 weeks after CAR-T infusion
• Overall response rate (ORR);
defined as the proportion of subjects who achieved CR, CR with partial hematologic recovery(CRh), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free status (MLFS), or partial remission (PR).
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Overall complete response rate (CRR);
defined as the proportion of subjects who achieved morphological complete response (CR),CR with partial hematologic recovery(CRh) and complete response with incomplete hematological recovery ( CRi ).
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Partial response rate (PRR);
defined as the proportion of subjects achieving partial response (PR).
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• The proportion of patients who achieved complete remission (CR) who tested negative for MRD (MRD-rate);
only used to evaluate subjects who achieve CR,CRh and CRi . In this study, the proportion of MRD-negative subjects was detected by flow cytometry. Sensitivity is defined as: collecting 100,000 nucleated cells in a bone marrow sample, of which the number of leukemia cells is less than 10 (i.e., MRD level \<10 -4 ). Response with MRD detection at low-level (CRMRD-LL) is included in this category of CR, CRh or CRi with MRD-negative. CRMRD-LL is currently only defined for NPM1-mutant and CBF-AML
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Median bone marrow blast percentage decline;
Median bone marrow blast percentage decline;
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Relapse-free survival (RFS);
defined only for patients achieving CR, CRh, or CRi; measured from the date of achievement of remission until the date of hematologic relapse or death from any cause; patients not known to have relapsed or died at last follow-up are censored on the date they were last known to be alive.
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Event-free survival (EFS);
used to evaluate all subjects . It is calculated from the start of cell infusion until treatment failure, relapse or death (various reasons). Subjects without the above events will be counted until the last follow-up examination date. For patients who did not achieve CR/CRh/ CRi , EFS was calculated from the start of cell infusion until disease progression or death. The first event shall prevail.
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Overall survival (OS);
used to evaluate all subjects. The time from cell infusion to death from any cause was calculated.
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Duration of response (DOR);
refers to the time from the first evaluation of CR, CRh, CRi , MLFS or PR to the first evaluation of disease recurrence or progression or death from any cause.
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Expansion and persistence of CAR-T cells (CAR copy number and CAR - T cell number)
CAR copy number and CAR - T cell number
Time frame: Days 4, 7, 10, 14 ,21,28 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
• The proportion of subjects with RCL detected in peripheral blood and the insertion site of CAR-T cell lentivirus within 15 years after the infusion of CLL1 and CD38 dual-target CAR-T injection.
• The proportion of subjects with RCL detected in peripheral blood and the insertion site of CAR-T cell lentivirus within 15 years after the infusion of CLL1 and CD38 dual-target CAR-T injection.
Time frame: within 15 years after the infusion of CLL1 and CD38 dual CAR-T injection
• CR with partial hematologic recovery rate (CRhR);
defined as the proportion of subjects who achieved CR with partial hematologic recovery.
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• CR with incomplete hematologic recovery rate (CRiR);
defined as the proportion of subjects who achieved CR with incomplete hematologic recovery
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion
• Morphologic leukemia-free state rate (MLFSR);
defined as the proportion of subjects who achieved Morphologic leukemia-free state
Time frame: 1month, 2 months, 3months, 6months ,9months,12months after CAR-T infusion