Childhood Acute Lymphoblastic Leukemia
Conditions
Brief summary
In this study, CAR-T will be administered to children with acute lymphoblastic leukemia to explore the effect of CAR-T intervention time on the duration of complete remission and further verify the long-term safety and efficacy of CAR-T treatment.
Detailed description
After clinician evaluation, if the child meets the study criteria and after adequate communication, the parent or legal guardian voluntarily joins the clinical study, CAR-T technique can be used for related treatment, and the long-term therapeutic effect can be observed. In this trial, 50 children were publicly enrolled and treated with CAR-T. Patients participating in the clinical trial will be tested and assessed in terms of treatment safety, efficacy, and duration of response.
Interventions
DRUGCD19 CAR-T
CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
DRUGCD22 CAR-T
CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
DRUGCD 19+22
CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
DRUGFludarabine
25mg/㎡ for D-4、D-3 and D-2
DRUGCyclophosphamide
500mg/㎡ for D-3 and D-2
Sponsors
The Second Hospital of Hebei Medical University
Hebei Senlang Biotechnology Inc., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
： 1. The treat history meeting the following 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
1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Severe/Adverse Events | 28 days | Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis |
| CAR-T Cell expansion level | 24 months | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate of complete remission and partial remission | 24 months | Objective response rate of complete remission and partial remission |
| Overall survival time | 24 months | Overall survival time |
Countries
China
Contacts
Primary ContactJianqiang Li, PhD&MD
Outcome results
None listed