Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma

Study Overview
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Brief Summary
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B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.

Official Title
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Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma

Conditions
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Lymphoma Leukemia

Intervention / Treatment
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* Genetic: Welgenaleucel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies Absolute lymphocyte count, ALC )≧600/μl HIV, HTLV, Syphilis negative GPT ≦200 U/L Cr ≦221 umol/L Adequate venous access for apheresis, and no other contraindications for leukapheresis. Voluntary informed consent is given. Exclusion Criteria: Body weight < 20Kg Pregnant women. Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. Previously treatment with any gene or cell therapy products. Any uncontrolled active medical disorder that would preclude participation as outlined. Expected survival< 12 weeks Received investigational drug or device within 30 days pre-trial; Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Welgenaleucel (UWC19)<br>The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times | Genetic: Welgenaleucel<br>* Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.<br>* Other names: UWC19;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The adverse events associated with CAR T cell product infusions are assessed. | The type, frequency, severity, and duration of adverse events will be summarized | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CAR-T cell, CD19, Lymphoma, Leukemia