Immunotherapy With CD19 CART-cells for B Cell Acute Lymphoblastic Leukemia

NCT03599375 | Unknown Phase 1

• 1 other identifier: FJLU-002
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the safety and clinical activity of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in treating patients with recurrent or refractory CD19 positive B cell ccute lymphoblastic leukemia,and dynamically observe the changes of CAR-T in patients and the residual tumor.

Conditions

Leukemia, B-Cell

Keywords

Chimeric Antigen Receptor-Modified T Cells; CART; Recurrent B Cell Acute Lymphoblastic Leukemia; refractory B Cell Acute Lymphoblastic Leukemia; ALL

Outcome Measures

Primary Outcomes (1)

• overall response rate(ORR)

  ORR is defined as the proportion of partial responses plus complete responses.

  Participants will be followed for the duration of the treatment, with an expected average of 3 months.

Secondary Outcomes (2)

• Progression free survival(PFS)

  15 years

• Overall survival(OS)

  15 years

Study Arms (1)

B-ALL treated with CD19 CART cell

EXPERIMENTAL

The qualified CD19-targeted CART cells will be transferred to patient for 3 days as follow:D1,10% fraction;D2,30%;D3 60%. The number of CART cells for each course will be about 1×106/kg. If complete response (CR) or complete response with incomplete hemogram recovery (CRi) in hemogram is achieved after the first course of treatment, further treatment will be decided according to the clinical assessment and the wishes of the patient.If partial response (PR) is achieved after the first course, 1 or 2 courses of treatment will be continued. If there is no response (NR) after the first course, the treatment will be ceased or restarted based on the clinical assessment or patients' wishes. Treatent may be discontinued due to any severe toxicity, such as cytokine release syndrom.

Biological: CD19-targeted CART cells

Interventions

CD19-targeted CART cells BIOLOGICAL

CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.

B-ALL treated with CD19 CART cell

Eligibility Criteria

• Age: 14 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Recurrent or refractory B cell derived acute lymphoblastic leukemia (ALL)
• Patients who have failed at least one line of a standard treatment without effective treatment measures at present
• CD19 expression on the surface of B-ALL cells must be detected
• KPS\>80
• Life expectancy \>3 months
• Patients must have adequate cardiac function (no electrocardiogram with obvious abnormality, LVEF≥50%),adequate pulmonary function as indicated by room air oxygen saturation of \> 90%, and adequate renal function (Cr≤2.5 times of the normal range)
• The alanine aminotransferase (ALT) and the aspartate aminotransferase (AST)≤ 3 times of the normal range, and the total bilirubin (TBIL)≤2.0mg/dl(34.2umol/L)
• Hemoglobin(Hgb)≥80g/L
• Without contraindication of apheresis and cell isolation
• Patients and their families volunteer to participate in the research with signed written informed consent

You may not qualify if:

• Other concurrent severe and/or uncontrolled medical conditions: patients with another primary malignant disease; another severe and/or life-threatening medical disease.
• Evidence of uncontrolled current serious active infection
• HIV/HBV/HCV infection
• Pregnancy and nursing females
• Systemic glucocorticoid therapy within one week

Sponsors & Collaborators

• jiuwei cui: lead

MeSH Terms

Conditions

Leukemia, B-Cell; Burkitt Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief

Model Details: Patients with recurrent or refractory CD19+ ALL receive CD19 CAR T-cell immunotherapy.

Study Record Dates

• First Submitted: July 15, 2018
• First Posted: July 26, 2018
• Study Start: May 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2021
• Last Updated: February 26, 2019

Record last verified: 2019-02