CD20-positive B-cell non-Hodgkin lymphoma
Conditions
Interventions
investigational material(s)
Generic name etc : CART001
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material
Sponsors
National Cancer Center Hospital East
Yamaguchi University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria including below but not limited to: 1) Patient with refractory CD20-positive B-cell non-Hodgkin lymphoma. 2) Patient with relapsed or refractory lymphoma after two lines of chemotherapy including Rituximab. 3) Patient has measurable lesions 4) Age at registration is of 20 years or older 5) ECOG Performance status, 0-2 6) Organ function is preserved by all of the following criteria. a) Absolute neutrophil count >= 1,000 /mm3 b) Platelets >= 80,000 /mm3 c) Hemoglobin >= 8.0 g/dL d) Total serum bilirubin ==92% (room air) i) PT =< 18 sec j) APTT =< 57 sec 7) Patient agrees to use adequate contraception for the duration of study period and for 6 months after the last study treatment. 8) The patient survival is expected to be longer than 2 months after first study treatment. 9) Witten informed consent is obtained before study participation.
Exclusion criteria
Exclusion criteria: Exclusion criteria including below but not limited to: 1) Synchronous or metachronous (within 2 years) malignancies. 2) History of genetic-based therapy 3) Tumor cell invasion into CNS 4) Active autoimmune disease requiring any therapies. 5) Patient who has received anti-cancer therapy, radiotherapy or other investigational drug within 2 weeks prior to study registration. 6) History of allogeneic stem cell transplantation. 7) Patient who cannot complete steroids therapy 72hr before apheresis or chemotherapy. 8) Patient who has or is suspected to have bacterial infection or virus infection. 9) Positive test result for HBs antigen, HBc antibody or HBV-DNA. 10) Active infection of HCV, HIV or HTLV. 11) Severe cardiovascular disease. 12) History of hypersensitivity reactions to streptomycin, amphotericin, bovine serum, rodent derived substances, or human serum albumin. 13) Patient during pregnancy or lactation. 14) Patient without compliance of study protocol. 15) Patient who is considered to interfere with evaluation of the study therapy or safety or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse events including the dose limiting toxicity on FCAR-CD20 therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics pharmacodynamics efficacy Profile of pharmacokinetics Pharmacodynamics Efficacy | — |
Countries
Japan
Outcome results
None listed