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| Name | Class |
|---|---|
| The Second Hospital of Hebei Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| volunteer | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T | Drug | CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Severe/Adverse Events | Number of Participants with Severe/Adverse Events as a Measure of Safety diagnosis | 28 days |
| CAR-T Cell expansion level | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate of complete remission and partial remission | Objective response rate of complete remission and partial remission | 24 months |
| Overall survival time | Overall survival time |
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Inclusion criteria:
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.
There is a measurable lesions before treatment at least;
ECOG score≤2;
To be aged 1 to 18 years;
More than a month lifetime from the consent signing date
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Li, PhD&MD | Contact | +8631189928689 | limmune@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin Luo, PhD&MD | The Second Hospital of Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2 Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D007252 | Influenza Vaccines |
| D003520 | Cyclophosphamide |
| D053493 | Cholestanetriol 26-Monooxygenase |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| CD22 CAR-T | Drug | CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells |
|
|
| CD 19+22 | Drug | CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells |
|
|
| Fludarabine | Drug | 25mg/㎡ for D-4、D-3 and D-2 |
|
|
| Cyclophosphamide | Drug | 500mg/㎡ for D-3 and D-2 |
|
|
| 24 months |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D010752 |
| Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000072501 | Cytochrome P450 Family 27 |
| D003577 | Cytochrome P-450 Enzyme System |
| D003580 | Cytochromes |
| D045762 | Enzymes and Coenzymes |
| D013250 | Steroid Hydroxylases |
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D006420 | Hemeproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |