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

NCT03811457 | Completed DMC

• 1 other identifier: UCAR019
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphoma Leukemia

Keywords

CAR-T cell, CD19, Lymphoma, Leukemia

Outcome Measures

Primary Outcomes (1)

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

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

  30 days

Study Arms (1)

Welgenaleucel (UWC19)

EXPERIMENTAL

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

Interventions

Welgenaleucel GENETIC

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

Also known as: UWC19

Welgenaleucel (UWC19)

Eligibility Criteria

• Age: Up to 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Body weight \< 20Kg
• Pregnant women.
• Uncontrolled active infection.
• Active hepatitis B or hepatitis C infection.
• 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.

Sponsors & Collaborators

• UWELL Biopharma: lead
• Liaocheng People's Hospital: collaborator

Study Sites (1)

Liaocheng People Hospital

Liaocheng, Shandong, 252000, China

Location

MeSH Terms

Conditions

Lymphoma; Leukemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Cheng-Yi Kuo, PhD

  UWELL Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: January 22, 2019
• Study Start: June 1, 2017
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: January 22, 2019

Record last verified: 2019-01

Locations

CN (1)