B-ALL
Conditions
Keywords
CD22 CAR-T， B-ALL
Brief summary
This is an open, single-arm, clinical study to evaluate efficacy and safety of anti CD22 CAR-T cell in the treatment of recurrent or refractory B-ALL
Detailed description
The CARs consist of an anti-CD22 single-chain variable fragment（scFv）, 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 CD22CAR-T in patients with recurrent or refractory B-ALL The Secondary research objectives: To investigate the cytokinetic characteristics of CD22CAR-T in patients with recurrent or refractory B-ALL
Interventions
BIOLOGICALCD22 CAR-T
Biological: CD22 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis
Sponsors
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 70 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with relapsed and refractory acute B-lymphoblastic leukemia who have any of the following: 1. B-ALL patients with relapse (including bone marrow morphological relapse 1 and minimal residual relapse 2) after remission by chemotherapy or autologous stem cell transplantation; 2. Primary B-ALL patients who can not be completely relieved by more than two times of repeated chemotherapy; 3. High risk primary B-ALL patients who have not been relieved but are not suitable for re intensive therapy after 1-2 times of chemotherapy; 2. Flow cytometry (FCM) showed CD 22 positive in bone marrow or peripheral blood; 3. There should be at least one assessable lesion in B-ALL patients with simple extramedullary recurrence; 4. The activity state score of the Eastern Cooperative Oncology Group (ECOG) was less than or equal to 2; 5. The estimated survival time is more than 3 months; 6. Need to sign informed consent.
Exclusion criteria
1. Serious cardiac insufficiency； 2. Has a history of severe pulmonary function damaging; 3. Other malignant tumors; 4. Serious infection or persistent infection and can not be effectively controlled； 5. Merging severe autoimmune diseases or immunodeficiency disease; 6. Patients with active hepatitis (HBV DNA or HCV RNA positive); 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（including a history of serious mental illness, substance abuse and addiction）
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 CD22 CAR-T 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