B-ALL Clinical Trial
Official title:
Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia
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
Status | Recruiting |
Enrollment | 20 |
Est. completion date | December 1, 2022 |
Est. primary completion date | September 1, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | BeiJing Ludaopei Hospital | Beijing | Yizhuang |
China | Hebei yanda Ludaopei Hospital | Hebei | Sanhe |
Lead Sponsor | Collaborator |
---|---|
Hebei Senlang Biotechnology Inc., Ltd. | Beijing Ludaopei Hospital, Hebei Yanda Ludaopei Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety: Incidence and severity of adverse events | 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 | First month post CAR-T cells infusion | |
Primary | Efficacy: Remission Rate | Remission Rate including complete remission(CR)?CR with incomplete blood count recovery(CRi)?No remission(NR) | 3 months post CAR-T cells infusion | |
Secondary | Efficacy:duration of response (DOR) | duration of response (DOR) | 24 months post CAR-T cells infusion | |
Secondary | Efficacy: progression-free survival (PFS) | progression-free survival (PFS) time | 24 months post CAR-T cells infusion | |
Secondary | CAR-T proliferation | 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 | 3 months post CAR-T cells infusion | |
Secondary | Cytokine release | Cytokine( IL-6,IL-10,IFN-?,TNF-a ) concentration (pg/mL) by flow cytometry method | First month post CAR-T cells infusion |
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