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

January 17, 2019 updated by: UWELL Biopharma
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Liaocheng, Shandong, China, 252000
        • Liaocheng People Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • UWC19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UWELL Biopharma

Collaborators

Liaocheng People's Hospital

Investigators

  • Study Director: Cheng-Yi Kuo, PhD, UWELL Biopharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 17, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 17, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCAR019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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