Non-hodgkin's Lymphoma
Conditions
Keywords
NHL，CD19
Brief summary
This is a study of patients with relapsed or refractory non-Hodgkin's lymphoma. To evaluate the safety and efficacy of SL1904B in patients with relapsed or refractory non-Hodgkin's lymphoma.
Detailed description
The CARs consist of an anti-CD19 single-chain variable fragment（scFv） that was derived from the FMC63 mouse hybridoma, a portion of the human CD137（4-1BB） molecule, and the intracellular component of the human CD3ζ molecule. Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy. The Main research objectives: To evaluate the safety and efficacy of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma The Secondary research objectives: To investigate the cytokinetic characteristics of SL1904B in patients with recurrent or refractory non-Hodgkin's lymphoma.
Interventions
BIOLOGICALCD19 CAR-T
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
Sponsors
Beijing Lu Daopei Hospital
Hebei Yanda Ludaopei Hospital
Hebei Senlang Biotechnology Inc., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Sign the informed consent form and be willing and able to comply with the visit, treatment regimen, laboratory examination and other requirements of the study as stipulated in the trial flow chart; 2. The diagnosis of patients with relapsed or refractory non-hodgkin lymphoma; 3. There should be at least one measurable tumor focus according to the RECIST version 1.1; 4. ECOG Scores: 0\ 2; 5. The expression of CD19 on the tumor cells was reported as positive by either immunohistochemistry or flow cytometry; 6. Estimated survival time was longer than 3 months; 7. main organ functions shall meet the following requirements including: serum creatinine ≤1.5 times the upper limit of normal value (ULN); ALT ULN 2.5 or less; AST ULN 2.5 or less; Total bilirubin ≤ 1.5ULN; Left ventricular ejection fraction (LVEF) ≥45%; Hemoglobin ≥90g/L; Platelet count ≥50×109/L; absolute Neutrophil count (ANC) ≥1.0×109/L; Blood oxygen saturation \>92%； 8. Peripheral blood mononuclear immune cells must be collected at least 2 weeks after the last radiotherapy or systemic treatment.
Exclusion criteria
1. Serious cardiac insufficiency； 2. Has a history of severe pulmonary function damaging; 3. With other tumors which is/are in advanced malignant and has/have systemic metastasis; 4. Merging the metabolic diseases (except diabetes); 5. Merging severe autoimmune diseases or immunodeficiency disease; 6. Patients with active hepatitis B or hepatitis C virus infection; 7. Patients with HIV infection or syphilis infection; 8. Has a history of serious allergies on Biological products (including antibiotics); 9. Participated in any other clinical drug trial for the last six months; 10. Being pregnant and lactating or having pregnancy within 12 months; 11. With other uncontrolled diseases and considered not suitable to participate by the researchers; 12. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Incidence and severity of adverse events | First month post CAR-T cells infusion | To evaluate the possible adverse events occurred within first one month after SL1904B infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity |
| Efficacy: Overall Remission Rate (ORR) | 3 months post CAR-T cells infusion | Overall Remission Rate (ORR) including partial remission and complete remission rate after infusion of SL1904B |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy:duration of response (DOR) | 24 months post CAR-T cells infusion | duration of response (DOR) |
| Efficacy: progression-free survival (PFS) | 24 months post CAR-T cells infusion | progression-free survival (PFS) time |
| CAR-T proliferation | 3 months post CAR-T cells infusion | the copy number of CD19 CAR- T cells in the genomes of PBMC by qPCR method and percentage of CD19 CAR- T cells measured by flow cytometry method |
| Cytokine release | First month post CAR-T cells infusion | Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method |
Countries
China
Contacts
Primary ContactPeihua Lu, PhD&MD
Backup ContactJianqiang Li, PhD&MD
Outcome results
None listed