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| Name | Class |
|---|---|
| KAEDI | OTHER |
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The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and B-cell acute lymphoblastic leukemia (B-ALL).
The investigators designed an KD-019 Chimeric Antigen Receptor(CAR) with FMC63 single-chain antibody fragment (Scfv). This CAR has a CD8 hinge and transmembrane domains and a 4-1BB costimulatory domain; T cells expressing this CAR release relatively low levels of cytokines. Subjects with relapsed/refractory CD19-positive B-cell Lymphoma and B-ALL can participate if all eligibility criteria are met. Subjects receive chemotherapy prior to the infusion of KD-019 CAR-T cells. After the infusion, subjects will accept follow-up for side effects and effect of KD-019 CAR-T cells by the sponsor. Study procedures may be performed while hospitalized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD19 CAR-T Cells Injection | Experimental | Dosage form:injection Dosage:1-5x10^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19 CAR-T Cells Injection | Biological | Autologous genetically modified anti-CD19 CAR transduced T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability. | The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined. | 0 to 14 days post infusion |
| Copies numbers of CAR in peripheral blood (PB) | Copies numbers of CAR in peripheral blood (PB) | 1 year post infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason | 2 years post infusion |
| Duration of Response after administration |
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Inclusion Criteria:
B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:
(1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.
5、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peixian Zhang | Contact | 86-0871-63211268 | px29@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Peixian Zhang | Kunming Yan'an Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kunming Yan'an Hospital, Oncology Department | Recruiting | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Duration of Response after administration
| 2 years post infusion |
| Progress Free Survival after administration | Progress Free Survival after administration | 2 years post infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |