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

UWELL Biopharma9 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphoma Leukemia

Interventions

Eligibility

Sex: ALLMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The adverse events associated with CAR T cell product infusions are assessed.

The type, frequency, severity, and duration of adverse events will be summarized

Time frame: 30 days