B-cell Acute Lymphoblastic Leukemia, B Cell Lymphoma
Conditions
Brief summary
The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia （B-ALL）.
Detailed description
The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.
Interventions
BIOLOGICALAnti-CD19 CAR-T Cells Injection
Autologous genetically modified anti-CD19 CAR transduced T cells
Sponsors
KAEDI
Yan'an Affiliated Hospital of Kunming Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients or their legal guardians voluntarily participate and sign the Informed Consent Document; 2. 18 Years and older, Male and female; 3. Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program; B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types: 1. B-cell acute lymphoblastic leukemia; 2. Indolent B-cell lymphomas; 3. Aggressive B-cell lymphoma; 4、 Subjects: (1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy. 5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements: 1. Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) \<3 ×upper limit of normal (ULN); 2. Total bilirubin ≤34.2μmol/L; 3. Serum creatinine\<220μmol/L; 4. Baseline oxygen saturation≥95%; 5. Left ventricular ejection fraction（LVEF）≥40%. 7、 Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2，Expected survival≥3 months;
Exclusion criteria
1. Pregnant (urine/blood pregnancy test positive) or lactating women; 2. Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion; 3. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment; 4. Active or uncontrollable infection within four weeks prior to enrollment; 5. Patients with active hepatitis B/C; 6. HIV-infected patients; 7. Severe autoimmune or immunodeficiency disorders; 8. Patients are allergic to macromolecule drugs such as antigens or cytokines; 9. Subjects participated in other clinical trials within 6 weeks before enrollment; 10. Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones); 11. Mental illness; 12. Drug abuse/addiction; 13. The investigators consider other conditions unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability. | 0 to 14 days post infusion | The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined. |
| Copies numbers of CAR in peripheral blood (PB) | 1 year post infusion | Copies numbers of CAR in peripheral blood (PB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response after administration | 2 years post infusion | Duration of Response after administration |
| Progress Free Survival after administration | 2 years post infusion | Progress Free Survival after administration |
| Overall survival | 2 years post infusion | For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason |
Countries
China
Contacts
Primary ContactPeixian Zhang
Outcome results
None listed