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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03811457
Recruitment Status : Completed
First Posted : January 22, 2019
Last Update Posted : January 22, 2019
Sponsor:
Collaborator:
Liaocheng People's Hospital
Information provided by (Responsible Party):
UWELL Biopharma

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lymphoma Leukemia Genetic: Welgenaleucel Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Welgenaleucel (UWC19)
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
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
Other Name: UWC19


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811457


Locations
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China, Shandong
Liaocheng People Hospital
Liaocheng, Shandong, China, 252000
Sponsors and Collaborators
UWELL Biopharma
Liaocheng People's Hospital
Investigators
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Study Director: Cheng-Yi Kuo, PhD UWELL Biopharma
More Information
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Responsible Party: UWELL Biopharma
ClinicalTrials.gov Identifier: NCT03811457    
Other Study ID Numbers: UCAR019
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UWELL Biopharma:
CAR-T cell, CD19, Lymphoma, Leukemia
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases