PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
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ClinicalTrials.gov Identifier: NCT02892695 |
Recruitment Status : Unknown
Verified December 2016 by PersonGen BioTherapeutics (Suzhou) Co., Ltd..
Recruitment status was: Recruiting
First Posted : September 8, 2016
Last Update Posted : December 6, 2016
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Condition or disease | Intervention/treatment | Phase |
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Acute Lymphocytic Leukemia Chronic Lymphocytic Leukemia Follicular Lymphoma Mantle Cell Lymphoma B-cell Prolymphocytic Leukemia Diffuse Large Cell Lymphoma | Biological: anti-CD19 CAR-NK cells | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Relapsed or Refractory Leukemia and Lymphoma |
Study Start Date : | September 2016 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | September 2019 |

Arm | Intervention/treatment |
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Experimental: CAR-NK Cell immunotherapy
Enrolled patients will receive CAR-NK cell immunotherapy with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion.
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Biological: anti-CD19 CAR-NK cells
The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD19 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD19.
Other Name: chimeric antigen receptor NK cells with specificity for CD19 |
- Adverse events attributed to the administration of the anti-CD19 CAR-NK cells [ Time Frame: 2 years ]
- Objective Response Rate [ Time Frame: Safety follow-up is 100 days from last CAR-NK infusion ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 3 Years to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male and female subjects with CD19+ B cell malignancies in patients who have no available curative treatment options except stem cell transplantation, with limited prognosis (several months to < 2 year survival) and no available treatment option to achieve complete remission prior to transplant. Some patients who have enrolled to other CD19-CAR-T cell therapy trials may be eligible if their CD19-CAR-T cells cannot be produced successfully because they have insufficient T cells to allow the CD19-CAR-T cells to be made; their T cells are inefficiently transduced with CAR viruses; or their CAR-T cell expansion is failed. All of those patients must meet the following criteria:
- 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 3 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.
- 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 NK 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.
Exclusion Criteria:
- 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.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02892695
Contact: Lin Yang, Ph.D. | 86-512-65922190 | lin.yang@persongen.com |
China, Jiangsu | |
PersonGen BioTherapeutics (Suzhou) Co., Ltd. | Recruiting |
Suzhou, Jiangsu, China, 215123 | |
Contact: Lin Yang, Ph.D. 86-512-65922190 info@persongen.com | |
Principal Investigator: Yangyi Bao, MD | |
Principal Investigator: Xiang Sun, MD | |
Principal Investigator: Lin Yang, Ph.D. |
Responsible Party: | PersonGen BioTherapeutics (Suzhou) Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT02892695 |
Other Study ID Numbers: |
PG-119-001 |
First Posted: | September 8, 2016 Key Record Dates |
Last Update Posted: | December 6, 2016 |
Last Verified: | December 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Lymphoma Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Prolymphocytic Leukemia, Prolymphocytic, B-Cell |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Leukemia, B-Cell Lymphoma, B-Cell |