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

Sponsor
UWELL Biopharma (Industry)
Overall Status
Completed
CT.gov ID
NCT03811457
Collaborator
Liaocheng People's Hospital (Other)
9
Enrollment
1
Location
1
Arm
19
Actual Duration (Months)
0.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Welgenaleucel
 N/A

Study Design

Study Type:
Interventional
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 :
Jun 1, 2017
Actual Primary Completion Date :
Dec 31, 2018
Actual Study Completion Date :
Dec 31, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The adverse events associated with CAR T cell product infusions are assessed. [30 days]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Liaocheng People Hospital Liaocheng Shandong China 252000

    Sponsors and Collaborators

    • UWELL Biopharma
    • Liaocheng People's Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    UWELL Biopharma
    ClinicalTrials.gov Identifier:
    NCT03811457
    Other Study ID Numbers:
    • UCAR019
    First Posted:
    Jan 22, 2019
    Last Update Posted:
    Jan 22, 2019
    Last Verified:
    Jan 1, 2019
    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:
    Lymphoma
    Leukemia

    Study Results

    No Results Posted as of Jan 22, 2019