A Study of Anti-CD19 CAR-T Cell Immunotherapy for Refractory /Relapsed B Cell Malignancies

NCT03191773 | Unknown Phase 1

• 1 other identifier: 2017-HS-32
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.

Conditions

Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (2)

• Number of participants with Adverse Events

  To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies.

  24 months

• Number of participants with clinical responses

  To determine if the treatment regimen can result in clinical regression of B cell malignancies in the patients as described above.

  24 months

Secondary Outcomes (1)

• Evaluation of overall survial

  24 months

Study Arms (1)

Anti-CD19 CAR transduced T cells

EXPERIMENTAL

Patients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells.

Combination Product: Drugs and anti-CD19 CAR transduced T cells

Interventions

Drugs and anti-CD19 CAR transduced T cells COMBINATION_PRODUCT

Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine. Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes.

Anti-CD19 CAR transduced T cells

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have a CD19+ B cell malignancy，including relapsed or refractory B cell leukemia and/or B cell lymphoma；
• Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis；
• Patients with history of allogeneic stem cell transplantation are eligible, providing 6 months had elapsed from SCT, they have no evidence of active graft-versus-host disease (GVHD) and no longer taking immunosuppressive agents during the treatment;
• Able to understand and sign the Informed Consent Document；
• There is no obvious dysfunctions in heart , liver, lung, kidney, and performance status with ECOG \< 2；
• Life expectancy：More than 3 months for leukemia and more than 6 months for lymphoma.

You may not qualify if:

• Patients that require urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression；
• Patients that have active hemolytic anemia；
• Patients who have uncontrollable infectious diseases within 2 weeks before enrollment;
• Patients with human immunodeficiency virus (HIV) antibody seropositive;
• Active infection of Hepatitis B virus and / or hepatitis C virus;
• Patients with any residual intracranial implants；
• Coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system；
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)；
• Concurrent opportunistic infections；
• Concurrent systemic steroid therapy；
• History of severe immediate hypersensitivity reaction to any of the agents used in this study；
• Women of child-bearing potential who are pregnant or breastfeeding；
• Patients with cardiac atrial or cardiac ventricular lymphoma involvement；
• Other anti-neoplastic investigational agents currently or within 30 days prior to start of the treatment；
• Psychiatric patients;

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Shenzhen Institute for Innovation and Translational Medicine: collaborator
• Guangzhou First People's Hospital: collaborator
• First People's Hospital of Foshan: collaborator
• Dongguan People's Hospital: collaborator
• The First Affiliated Hospital of Guangdong Pharmaceutical University: collaborator

Study Sites (5)

Department of Hematology, Dongguan People's Hospital

Dongguan, Guangdong, China

RECRUITING

Department of Hematology, the First People's Hospital of Foshan

Foshan, Guangdong, China

RECRUITING

Department of Hematology, Guangzhou First People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Department of Hematology, The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

RECRUITING

Department of Hematology,the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma

Interventions

Pharmaceutical Preparations

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; Leukemia, B-Cell; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ying Feng, MD

  Second Affiliated Hospital of Guangzhou Medical University

  STUDY DIRECTOR

• Mingjun Wang, MD

  Shenzhen Institute for Innovation and Translational Medicine

  STUDY DIRECTOR

Central Study Contacts

Ying Feng, MD

CONTACT

0086 13602723030; fyzlply@163.com

Mingjun Wang, MD

CONTACT

0086 15814723218; mingjunw429@163.com

Study Design

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

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: June 30, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)