CAR-T Cell Immunotherapy in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
Study Evaluating the Efficacy and Safety of PCAR-019 in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
1 other identifier
interventional
10
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedOctober 25, 2016
October 1, 2016
1.9 years
June 28, 2016
October 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells
2 years
Secondary Outcomes (1)
Phase II: Objective Response Rate
Safety follow-up is 100 days from last CAR-T infusion.
Study Arms (1)
PCAR-019
EXPERIMENTALEnrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.
Interventions
Eligibility Criteria
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 18 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 ≥ 9.0g/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 at the time of screening.
- 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.
- Previously treatment with any gene therapy products.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.lead
- The First People's Hospital of Hefeicollaborator
- Hefei Binhu Hospitalcollaborator
- Anhui Provincial Hospitalcollaborator
Study Sites (1)
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Suzhou, Jiangsu, 215123, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
June 28, 2016
First Posted
June 30, 2016
Study Start
October 1, 2016
Primary Completion
September 1, 2018
Study Completion
September 1, 2019
Last Updated
October 25, 2016
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share