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

Lymphoma Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03811457
• Other study ID #: UCAR019
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2019
• Source: UWELL Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Lymphoma
• Lymphoma Leukemia

Intervention

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

Locations

Country	Name	City	State
China	Liaocheng People Hospital	Liaocheng	Shandong

Sponsors (2)

Lead Sponsor	Collaborator
UWELL Biopharma	Liaocheng People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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