Study Evaluating the Efficacy and Safety of PCAR-019 in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma

NCT02851589 | Unknown Phase 1 DMC

• 1 other identifier: PG-019-002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.

Conditions

Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Follicular Lymphoma; Mantle Cell Lymphoma; B-cell Prolymphocytic Leukemia; Diffuse Large Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Phase I: Adverse events attributed to the administration of PCAR-019

  2 years

Secondary Outcomes (1)

• Phase II: Objective Response Rate

  2 years

Study Arms (1)

PCAR-019

EXPERIMENTAL

Enrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.

Biological: PCAR-019 (anti-CD19 CAR-T cells)

Interventions

PCAR-019 (anti-CD19 CAR-T cells) BIOLOGICAL

Also known as: chimeric antigen receptor T cells with specificity for CD19

PCAR-019

Eligibility Criteria

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

You may qualify if:

• Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled:
• Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.
• Patients 14 years of age or older, and must have a life expectancy \> 12 weeks.
• Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
• Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
• Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR T cells.
• Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10\^9/L, Hb ≥ 6.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
• Ability to give informed consent.

You may not qualify if:

• The transduction efficiency of the T cells is less than 30% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
• Pregnant or nursing women may not participate.
• Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
• History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
• The existence of unstable or active ulcers or gastrointestinal bleeding.
• Patients need anticoagulant therapy (such as warfarin or heparin).
• Patients need long-term antiplatelet therapy (aspirin at a dose \> 300mg/d; clopidogrel at a dose \> 75mg/d).
• Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.

Sponsors & Collaborators

• PersonGen BioTherapeutics (Suzhou) Co., Ltd.: lead
• Anhui Provincial Hospital: collaborator

Study Sites (1)

PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Suzhou, Jiangsu, 215123, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Leukemia, Prolymphocytic, B-Cell; Lymphoma, Large B-Cell, Diffuse

Interventions

Immunotherapy, Adoptive; Sensitivity and Specificity; Antigens, CD19

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; Lymphoma, Non-Hodgkin; Lymphoma; Leukemia, Prolymphocytic; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Statistics as Topic; Mathematical Concepts; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Antigens, CD; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Antigens, Differentiation, B-Lymphocyte; Minor Histocompatibility Antigens; Histocompatibility Antigens; Isoantigens; Biomarkers

Study Officials

• Xingbing Wang, Ph.D.

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Xin Liu, Ph.D.

  Anhui Provincial Hospital

  PRINCIPAL INVESTIGATOR

• Lin Yang, Ph.D.

  PersonGen BioTherapeutics (Suzhou) Co., Ltd.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Yang, Ph.D.

CONTACT

86-512-65922190; info@persongen.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: July 28, 2016
• First Posted: August 1, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2019
• Last Updated: August 1, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)