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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02819583
Other study ID # PG-019-001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received June 28, 2016
Last updated October 23, 2016
Start date October 2016
Est. completion date September 2019

Study information

Verified date October 2016
Source PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Contact Lin Yang, Ph.D.
Phone 86-512-65922190
Email info@persongen.com
Is FDA regulated No
Health authority China: National Health and Family Planning Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date September 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

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:

1. 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+.

2. Patients 18 years of age or older, and must have a life expectancy > 12 weeks.

3. Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.

4. Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.

5. 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.

6. 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.

7. Ability to give informed consent.

Exclusion Criteria:

1. 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.

2. Pregnant or nursing women may not participate.

3. Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.

4. 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.

5. History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.

6. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.

7. Previously treatment with any gene therapy products.

8. The existence of unstable or active ulcers or gastrointestinal bleeding.

9. Patients need anticoagulant therapy (such as warfarin or heparin).

10. Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).

11. Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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


Locations

Country Name City State
China PersonGen BioTherapeutics (Suzhou) Co., Ltd. Suzhou Jiangsu

Sponsors (4)

Lead Sponsor Collaborator
PersonGen BioTherapeutics (Suzhou) Co., Ltd. Anhui Provincial Hospital, Hefei Binhu Hospital, The First People's Hospital of Hefei

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells 2 years Yes
Secondary Phase II: Objective Response Rate Safety follow-up is 100 days from last CAR-T infusion. No
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