Refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation
Conditions
Interventions
investigational material(s)
Generic name etc : TBI-1301-A
INN of investigational material : -
Therapeutic category code : 639 Other biological preparations
Dosage and Administration for Investigationa
Sponsors
Dokkyo Medical University, Tokyo University. Nagoya City University, Mie University, Osaka International Cancer Institute, Kyushu University, Nagasaki University, Kagoshima University, Imamura General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1) Patient with refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation from his/her relative or from an unrelated individual registerated in Japan Marrow Donor Program (JMDP) 2) HLA-A*02:01 or HLA-A*02:06 positive 3) NY-ESO-1-expression in tumor-infiltrated tissue (skin, lypph node, etc) or peripheral blood by immunohistochemistry or PCR 4) (Only secondary registration) Having a donor who matches eligibility criteria 5) ECOG Performance Status, 0 ~ 2 6) Age >=20 years on consent 7) Life expectancy >= 12 weeks after consent 8) No severe damage on the major organs (bone marrow, heart, lung, liver, kidney, etc) and meet the following lab value criteria; T. billirubin =55% SpO2 >=94% 9) (only secondary registration) Completion of TBI-1301-A preparation 10) Ability to understand the study contents and to give a written consent at his/her free will Donor: 1) Original donor of hematopoetic stem cell transplantation 2) Age >=20 (20<= Age <=57, in case of an unrelated person coordinated by JMDP) years on consent 3) Ability to understand the study contents and to give a written consent at his/her free will
Exclusion criteria
Exclusion criteria: Patients: 1) The following serious complications are excluded from the study; Unstable angina, cardiac infarction, or heart failure Uncontrolled diabetes or hypertension Active infection Obvious interstitial pneumonia or lung fibrosis by chest X-ray Active autoimmune disease requiring steroids or immunosuppressive therapy 2) Serious hypersensitivity 3) Tumor cell invasion into CNS 4) Active multiple cancer 5) History of serious hypersensitivity reactions to bovine or murine derived substances, human serum albumin, streptomycin sulfate or amphotericin B 6) History of hypersensitivity reaction to drugs used in this study 7) Recurrence within 30 days after hematopoietic stem cell transplantation 8) GVHD >= Grade 3 (based on the guideline given JSHCT) 9) Uncontrollable pleural effusion, ascites or pericardial effusion 10) Antitumor therapy (chemotherapy, molecular targeted therapy, immunotherapy, radiation therapy, etc.) which are performed or will be performed within 4 weeks prior to the pre-treatment 11) Psycological disorder or drug dependency which may have impact on the consent 12) Pregnant females, lactating females (except when they cease and don't resume lactation) or female and male patients who cannot agree to practice the adequate birth control from the consent to at lease 6 months after the transfusion of TBI-1301-A 13) Any other inadequacy for this study Donor: 1) Positvity fo any of HBs antigen, HBV-DNA, HCV antibody, HCV-RNA, HIV antibody, HIV-RNA, serologic test of syphilis and parvovirus B19-DNA 2) Psycological disorder or drug dependency which may have impact on the consent 3) Any other inadequacy for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Safety - Frequency of occurring adverse event - Frequency of occurring product failure - Appearance of replication competent retrovirus (RCR) - Appearance of clonality | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1) Pharmacokinetics of blood TBI-1301-A 2) Clinical effects 3) Transition of laboratory test values 4) Appearance and severity of GVHD | — |
Countries
Japan
Outcome results
None listed