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

UWELL Biopharma

Status: Completed

Conditions: Lymphoma Leukemia

Treatments: Genetic: Welgenaleucel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03811457

UCAR019

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: Under 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Welgenaleucel (UWC19)

Experimental group

Description:

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

Treatment:

Genetic: Welgenaleucel