B-ALL
Conditions
Keywords
B-ALL, CD19 CAR-T
Brief summary
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD19 CAR-T cell in the treatment of recurrent or refractory B-ALL
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 1904B in patients with recurrent or refractory B-ALL The Secondary research objectives: To investigate the cytokinetic characteristics of 1904B in patients with recurrent or refractory B-ALL
Interventions
BIOLOGICALCD19 CAR-T
Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
Sponsors
Hebei Yanda Ludaopei Hospital
Beijing Lu Daopei Hospital
Hebei Senlang Biotechnology Inc., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Sign the informed consent 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. A definite diagnosis of B-cell Lymphocyte Leukemia, which meets any of the following criteria: Relapsed : a) relapsed within 12 months after first remission;Refractory: a) no remission after six weeks of induction therapy or no remission after two courses of induction therapy; b) relapsedafter CR for 2 or more times; c) The first relapse after chemotherapy and no remission after at least one salvage treatment; c) relapsed after hematopoietic stem cell transplantation; 3. ECOG Scores: 0\ 2 4. CD19 positivewere detected by immunohistochemistry or flow cytometry; 5. Estimated survival time\>3 months; 6. 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. Severe or persistent infection that cannot be effectively controlled； 5. Merging severe autoimmune diseases or immunodeficiency disease; 6. Patients with active hepatitis B or hepatitis C(\[HBVDNA+\]or \[HCVRNA+\]); 7. Patients with HIV infection or syphilis infection; 8. Has a history of serious allergies on Biological products (including antibiotics); 9. Being pregnant and lactating or having pregnancy within 12 months; 10. 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: Remission Rate | 3 months post CAR-T cells infusion | Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR) |
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