Acute Lymphocytic Leukemia, B-cell Prolymphocytic Leukemia, Chronic Lymphocytic Leukemia, Diffuse Large Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma
Conditions
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.
Interventions
BIOLOGICALPCAR-019 (anti-CD19 CAR-T cells)
Sponsors
The First People's Hospital of Hefei
Hefei Binhu Hospital
Anhui Provincial Hospital
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Phase II: Objective Response Rate | Safety follow-up is 100 days from last CAR-T infusion. |
Countries
China
Contacts
Primary ContactLin Yang, Ph.D.
Outcome results
None listed