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

NCT ID: NCT03811457

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2018-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Welgenaleucel

Intervention Type: GENETIC

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

Interventions

Welgenaleucel

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

Intervention Type: GENETIC

Other Intervention Names

UWC19

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.

• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liaocheng People's Hospital

OTHER

Sponsor Role: collaborator

UWELL Biopharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cheng-Yi Kuo, PhD

Role: STUDY_DIRECTOR

UWELL Biopharma

Locations

Liaocheng People Hospital

Liaocheng, Shandong, China

Countries

China

Other Identifiers

UCAR019

Identifier Type: -

Identifier Source: org_study_id