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| Name | Class |
|---|---|
| Shanghai Cell Therapy Group Co.,Ltd | INDUSTRY |
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This is a single arm,open-label, non-randomized phase 2 study to determine the efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BZ019 | Experimental | The subjects are enrolled into single-dose(1~5x10^6/kg) of BZ019 ( non viral vector CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BZ019 | Biological | A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV). |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Clinical response will be assessed by RECIST 1.1. | Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) | Peak Plasma Concentration (Cmax) | Month 12 |
| Pharmacodynamics (PD) | PD of IL-2, IL-4, IL-6,IL-10, IL-15, IFN-γ, TNF-α will be analysed after CAR T cell infusion |
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Inclusion Criteria:
B) Subjects must be accepted adequate treatment before and have received at least 2 lines of treatment or relapse or progress after autologous hematopoietic stem cell transplantation, and the treatment history at least include:
a)Treatment by CD20 monoclonal antibody (Rituximab) except for CD20 negative; b) A chemotherapy regimen containing anthracyclines.
C)With Relapsed or refractory large B-cell lymphoma when screening:
a) The definition of relapsing is as follows:PD occurs at least after remission (including PR or CR) with standard therapy (including Rituximab) b) The definition of refractory is as follows: i) No response to the last treatment, including:The best response to the latest treatment is PD or SD; ii)Disease progression after ASCT or recurrence within ≤ 12 months (recurrence must be confirmed by biopsy), or if receiving remedial treatment after ASCT, the subject must have no reaction or recurrence after the last treatment.
D) CD19+ which was detected by immunocytochemistry or flow cytometric ;
A)Renal function defined as:
a)A serum creatinine of ≤1.5 x ULN or Estimated Glomerular Filtration Rate (eGFR) ≥ 60 mL/min/1.73 m^2;
B)Liver function defined as:
b) Alanine Aminotransferase (ALT) ≤ 5 x ULN;Bilirubin ≤ 2.0 mg/dl with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN; c) Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygenation > 91% on room air;
Exclusion Criteria:
• Patients who have previously received any anti-CD45, anti-CD19 or anti-CD3 therapy;
Previous or concurrent malignancy with the following exceptions:
Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study
A primary malignancy which has been completely resected and in complete remission for ≥ 5 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhang Yan, Ph. D | Contact | 021-67091122 | 1r1-7v5o4ef29a@dingtalk.com | |
| Liang Lijuan, Bachelor | Contact | 021-67091022 | lianglijuan3710@dingtalk.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mengchao Cancer Hospital | Recruiting | Shanghai | Shanghai Municipality | 201805 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36532014 | Derived | Zhang Y, Lin Z, Zhang F, Chen X, Yang Y, Fu X, Li Z, Sun Y, Qian Q. Rapid response in relapsed follicular lymphoma with massive chylous ascites to anti-CD19 CAR T therapy using Piggy Bac: A case report. Front Immunol. 2022 Dec 1;13:1007210. doi: 10.3389/fimmu.2022.1007210. eCollection 2022. |
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| Month 12 |
| Quality of life(QOL) | Quality of life will be assessed by EQ-5D health Index scale | Month 12 |