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

Primary Purpose

Lymphoma Leukemia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Welgenaleucel
Sponsored by
UWELL Biopharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma Leukemia focused on measuring CAR-T cell, CD19, Lymphoma, Leukemia

Eligibility Criteria

undefined - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Liaocheng People Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Welgenaleucel (UWC19)

Arm 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

Outcomes

Primary Outcome Measures

The adverse events associated with CAR T cell product infusions are assessed.
The type, frequency, severity, and duration of adverse events will be summarized

Secondary Outcome Measures

Full Information

First Posted
January 17, 2019
Last Updated
January 17, 2019
Sponsor
UWELL Biopharma
Collaborators
Liaocheng People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03811457
Brief Title
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Official Title
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UWELL Biopharma
Collaborators
Liaocheng People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma Leukemia
Keywords
CAR-T cell, CD19, Lymphoma, Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Welgenaleucel (UWC19)
Arm Type
Experimental
Arm 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
Intervention Type
Genetic
Intervention Name(s)
Welgenaleucel
Other Intervention Name(s)
UWC19
Intervention Description
Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
Primary Outcome Measure Information:
Title
The adverse events associated with CAR T cell product infusions are assessed.
Description
The type, frequency, severity, and duration of adverse events will be summarized
Time Frame
30 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-Yi Kuo, PhD
Organizational Affiliation
UWELL Biopharma
Official's Role
Study Director
Facility Information:
Facility Name
Liaocheng People Hospital
City
Liaocheng
State/Province
Shandong
ZIP/Postal Code
252000
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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