Investigator-initiated multi-institutional phase I clinical trial of NY-ESO-1-specific TCR gene-modified T cell therapy for adult T cell leukemia/lymphoma patients relapsed after allogeneic hematopoietic stem cell transplantatio
- Conditions
- Refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation
- Registration Number
- JPRN-UMIN000031853
- Lead Sponsor
- agasaki University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 1
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety - Frequency of occurring adverse event - Frequency of occurring product failure - Appearance of replication competent retrovirus (RCR) - Appearance of clonality
- Secondary Outcome Measures
Name Time Method 1) Pharmacokinetics of blood TBI-1301-A 2) Clinical effects 3) Transition of laboratory test values 4) Appearance and severity of GVHD