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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B cell Non-Hodgkin's Lymphoma patients.
The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation and Follow-up Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| C-CAR039 | Experimental | Autologous C-CAR039 administered by intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19/CD20-directed Chimeric Antigen Receptor T Cells | Biological | Autologous 2nd generation CD19/CD20-directed Chimeric Antigen Receptor T Cells, single infusion intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Observation | Incidence of adverse events after C-CAR039 infusion. Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity | up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration (Cmax) of C-CAR039 in the peripheral blood. | Detect Chimeric Antigen Receptor-T copies number by quantitative polymerase chain reaction(qPCR). | Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24 |
| Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood. |
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Inclusion Criteria:
The patient volunteered to participate in the study and signed the Informed Consent;
Age, 18-70 years (include 18 and 70), male or female;
Expected survival ≥ 12 weeks
Eastern Cooperative Oncology Group score 0-2
CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;
No contraindications of apheresis.
At least one measurable lesion according to Lugano 2014 criteria;
Adequate organ function and adequate bone marrow reserve
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
Detect Chimeric Antigen Receptor-T copies number by qPCR. |
| Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24 |
| Peripheral blood duration of C-CAR039 in the peripheral blood after infusion. | Detect Chimeric Antigen Receptor-T copies number by qPCR. | Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24 |
| Area under the curve 0h-28d of C-CAR039 in the peripheral blood. | Detect Chimeric Antigen Receptor-T copies number by qPCR. | Baseline, Days 4, 7, 10 and weeks 2, 3, 4 |
| Overall response rate (ORR) | Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria. | 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months |
| Duration of response (DOR) | The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion. | up to 24 months |
| Progression-free survival (PFS) | The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death. | 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months |
| Overall survival (OS) | The time from C-CAR039 infusion to the date of death. | up to 24 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |