Acute Myeloid Leukemia, Mixed Phenotype Acute Leukemia, T Lymphoblastic Leukemia/Lymphoma
Conditions
Keywords
CD7 Positive, CAR-T
Brief summary
This is a prospective,open-label, single center and single arm phase 1/2 study to evaluate the efficacy and safety of T cells expressing humanized CD7 chimeric antigen receptors treatment for patients with refractory/relapsed CD7 positive acute leukemia.
Detailed description
The patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory acute leukemia.
Interventions
BIOLOGICALHumanized CD7 CAR-T cells
Split intravenous infusion of CD7 CAR-T cells \[dose escalating infusion of (0.5-10)x10\^6 CD7 CAR-T cells/kg
Sponsors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed CD7 positive relapsed/refractory acute leukemia. 2. Age 12-65 years. 3. Eastern Cooperative Oncology Group (ECOG) score 0-2. 4. CD7 on leukemia is \>30% positive detected with flow cytometry. 5. Patients with left ventricular ejection fraction ≥ 0.5 by echocardiography or grade I/II cardiovascular dysfunction according to the New York Heart Association Classification. 6. Patients with aspartate aminotransferase or glutamic-pyruvic transaminase \> 3x upper limit of normal or bilirubin \> 2.0 mg/dL.
Exclusion criteria
1. Patients are pregnant or lactating 2. Patients with congenital immunodeficiency. 3. Patients with central nervous system leukemia. 4. Patients with uncontrolled active infection. 5. Patients with active hepatitis B or hepatitis C infection. 6. Patients with HIV infection. 7. Patients with atrial or venous thrombosis or embolism. 8. Patients with myo-infarction or severe arrythmia in the recent 6 months. 9. Other comorbidities that investigators considered not suitable for this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events | 12 months | Adverse events are evaluated with CTCAE V5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 2 years | ORR includes CR, CRi, MLFS and PR. Complete remission (CR)#Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0x 10\^9/L; platelet count \>100x10\^9/L. CR with incomplete hematologic recovery (CRi)#All CR criteria except for residual neutropenia (\<1.0x10\^9/L) or thrombocytopenia (\<100x10\^9/L). Morphologic leukemia-free state (MLFS): Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required. Partial remission (PR): All hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. |
| Cumulative incidence of relapse(CIR) | 2 years | time from the date of achievement of a remission until the date of relapse. |
| the duration of CAR T-cells in vivo | 2 years | the time of CAR-T cells' persistence in blood and the copies of CAR-T cells |
Countries
China
Contacts
Primary Contactxiaowen tang, Ph.D
Backup ContactLin Yang, Ph.D
Outcome results
None listed