Trial | NCT03811457  Report issue

Official Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    9
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 Started
Jun 01
2017
Primary Completion
Dec 31
2018
Study Completion
Dec 31
2018
Last Update
Jan 22
2019

Genetic Welgenaleucel

Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.

  • Other names: UWC19

Welgenaleucel (UWC19) Experimental

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

Criteria 

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.
No Results Posted