CD19+Targeted CAR-T Cell Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma

NCT04271410 | Unknown Phase 1 DMC

• 1 other identifier: PBC004
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.

Conditions

Leukemia; Lymphoma, Large B-Cell, Diffuse; Leukemia, B-cell; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell

Keywords

Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Adverse events that related to treatment

  Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

  2 years

• The response rate of CD19 CAR-T treatment in patients with relapse/refractory B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy

  The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline

  2 years

Secondary Outcomes (6)

• Rate of CD19 CAR-T cells in bone marrow and peripheral blood

  2 years

• Quantity of CD19 CAR copies in bone marrow and peripheral blood

  2 years

• Cellular kinetics of CD19 positive cells in bone marrow

  1 years

• Duration of Response (DOR) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma

  2 years

• Progress-free survival(PFS) of CD19 CAR-T treatment in patients with refractory/relapsed B Cell Leukemia and Lymphoma

  2 years

Study Arms (1)

CD19 CAR-T cells treat

EXPERIMENTAL

Patients will be be treated with CD19 CAR-T cells

Biological: CD19 CAR-T cells

Interventions

CD19 CAR-T cells BIOLOGICAL

CD19 CAR-T cell therapy

CD19 CAR-T cells treat

Eligibility Criteria

• Age: 2 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent；
• Diagnose as relapsed/refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
• Failed to standard chemotherapy regimens;
• Relapse after complete remission, high-risk and / or refractory patients ;
• Relapse after hematopoietic stem cell transplantation;
• For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
• Evidence for cell membrane CD19 expression；
• All genders ，ages: 2 to 75 years；
• The expect time of survive is above 3 months;
• KPS\>60；
• No serious mental disorders ;
• Left ventricular ejection fraction ≥50%
• Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
• Sufficient renal function defined by creatinine clearance≤2 x ULN;
• Sufficient pulmonary function defined by indoor oxygen saturation≥92%;

You may not qualify if:

• Previous history of other malignancy;
• Presence of uncontrolled active infection;
• Evidence of disorder that need the treatment by glucocorticoids;
• Active or chronic GVHD；
• The patients treatment by inhibitor of T cell；
• Pregnant or breasting-feeding women;
• Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.

Sponsors & Collaborators

• Chongqing Precision Biotech Co., Ltd: lead

Study Sites (1)

920th Hospital of Joint Logistics Support Force

Kunming, Yunnan, China

RECRUITING

MeSH Terms

Conditions

Leukemia; Lymphoma, Large B-Cell, Diffuse; Leukemia, B-Cell; Lymphoma, B-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sanbin Wang, MD

  920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  PRINCIPAL INVESTIGATOR

• Cheng Qian, PhD

  Chongqing University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhi Yang, PhD

CONTACT

86-13206140093; yangzhi@precision-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 17, 2020
• Study Start: June 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: July 1, 2024
• Last Updated: April 18, 2023

Record last verified: 2023-03

Locations

CN (1)