CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia
NCT ID: NCT04626765
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
50 participants
INTERVENTIONAL
2020-04-01
2023-05-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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volunteer
The child's parents or legal guardians voluntarily signed the informed consent form, and the child himself/herself met the enter criteria for the diagnosis of patients with acute B-lymphoblastic leukemia (B-ALL) expressing specific target antigens
CD19 CAR-T
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
CD22 CAR-T
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
CD 19+22
CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
Fludarabine
25mg/㎡ for D-4、D-3 and D-2
Cyclophosphamide
500mg/㎡ for D-3 and D-2
Interventions
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CD19 CAR-T
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
CD22 CAR-T
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
CD 19+22
CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
Fludarabine
25mg/㎡ for D-4、D-3 and D-2
Cyclophosphamide
500mg/㎡ for D-3 and D-2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Recurrence of lymphoma patients with imaging (CT/MRI/PET-CT) detection and pathological diagnosis, or recurrence including bone marrow morphology relapse and the MRD recurrence of myeloma patients or leukemia patients, after chemotherapy or stem cell transplantation; Can't get complete remission (including MRD positive) after more than twice repeated chemotherapy of incipient lymphoma, myeloma or leukemia patients; One or twice chemotherapy cannot get remission again (including MRD positive), but not suitable for chemotherapy of incipient lymphoma, myeloma or leukemia patients.
2. There is a measurable lesions before treatment at least;
3. ECOG score≤2;
4. To be aged 1 to 18 years;
5. More than a month lifetime from the consent signing date
Exclusion Criteria
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
1 Year
18 Years
ALL
No
Sponsors
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The Second Hospital of Hebei Medical University
OTHER
Hebei Senlang Biotechnology Inc., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jianmin Luo, PhD&MD
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Hebei Medical University
Locations
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No.2 Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Jianqiang Li, PhD & MD
Role: primary
Jianmin Luo, PhD & MD
Role: backup
Other Identifiers
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CAR-T for Childhood B-ALL
Identifier Type: -
Identifier Source: org_study_id