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OpenTrials
Completed

NCT Number: NCT03811457

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

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.

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Key information

Conditions

Lymphoma Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liaocheng People Hospital

Liaocheng, Shandong, 252000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Welgenaleucel

Genetic

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

Other names: UWC19

Primary outcomes

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

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

UWELL Biopharma

Industry

Collaborators

  • Liaocheng People's Hospital

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 22, 2019
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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