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

Not Applicable

Completed

• Conditions: Lymphoma Leukemia
• Interventions: Genetic: Welgenaleucel

• Registration Number: NCT03811457
• Lead Sponsor: UWELL Biopharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-01-17
• Last Update Submitted: 2019-01-17
• Study First Posted: 2019-01-22
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Welgenaleucel (UWC19)	Welgenaleucel	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Liaocheng People Hospital; 🇨🇳 Liaocheng, Shandong, China