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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR1800016541 | Registry Identifier | Chinese Clinical Trial Registry |
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This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Primary objective:
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19-CAR-T Cells | Experimental | Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19-CAR-T Cells | Biological | T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, ORR | The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR). | Up to Day90 after the CD19-CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of CAR-T cells remaining in vivo | Measure and analyze monthly | 2 years after cell infusion. |
| The lifetime of CAR-T cells remaining in vivo | Measure and analyze monthly |
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Inclusion Criteria:
7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhongwei Xu, MD, Phd | Contact | +86 010-69739722 | willyxu001@bioceltech.com |
| Name | Affiliation | Role |
|---|---|---|
| Peihua Lu, MD, PhD | Hebei Yanda Ludaopei Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebei Yanda Ludaopei Hospital | Recruiting | Langfang | Hebei | 065000 | China |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| 2 years after cell infusion. |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |