CD19+ acute B-lymphocytic leukemia and diffuse large B-cell lymphoma
Conditions
Interventions
B-ALL low dose:infusion of 0.1×10^6 CAR+ T Cells/kg
B-ALL intermediate dose:infusion of 1×10^6 CAR+ T Cells/kg
B-ALL high dose:infusion of 3×10^6 CAR+ T Cells/kg
DLBCL low dose:Infusion of 0.2×10^6 CAR+ T Cells/kg
DLBCL intermediate dose:Infusion of 2×10^6 CAR+ T Cells/kg
DLBCL high dose:Infusion of 3×10^6 CAR+ T Cells/kg
Sponsors
The First Affiliated Hospital of Xiamen University
Eligibility
Sex/Gender
All
Age
3 Years to 70 Years
Inclusion criteria
Inclusion criteria: For all: 1. Male or female aged 3-70 years; 2. Histologically confirmed diagnosis of CD19+ B-ALL per National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1); 3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions): (1) CR not achieved after standardized chemotherapy; (2) CR achieved following the first induction, but CR duration is 5%; 5. Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments; 6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent. For DLBCL: 1. Male or female aged 18-70 years; 2. Histologically confirmed diagnosis of DLBCL per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL transformed from follicular lymphoma and Chronic Lymphoblastic Leukemia/Small Lymphocyte Lymphoma and PMBCL; 3. Relapsed or refractory DLBCL (meeting one of the following conditions): (1) Recurrence, progression or SD after treatment with second-line or above second-line chemotherapy regimens; (2) Recurrence or progression after autologous hematopoietic stem cell transplantation; 4. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: For ALL: 1. History of hypersensitivity to any component of cell product; 2. Patients with extramedullary lesions; 3. Recurrence after allogeneic hematopoietic stem cell transplantation; 4. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/ lymphoma per WHO Classification Criteria; 5. Central nervous system leukemia (CNS2 or CNS3), resistant to intrathecal injecting of chemotherapeutic drugs, and/or undergoing skull and/or spine radiotherapy; patients with history of CNS but effectively controlled to allow enrollment; 6. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies; 7. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study. For DLBCL: 1. History of hypersensitivity to any component of cell product; 2. Prior treatment with any CAR-T cell product or other genetically-modified T cell therapies; 3. Recurrence after allogeneic hematopoietic stem cell transplantation; 4. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade of Toxicities and Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(up to 2 years)(for ALL arm);EFS (up to 2 years)(for ALL arm);OS (up to 2 years)(For ALL arm);ORR(up to 2 years)(For DLBL arm);DCR (up to 2 years)(For DLBCL arm); | — |
Countries
China
Contacts
Public ContactBing Xu
The First Affiliated Hospital of Xiamen University
Outcome results
None listed