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 transplantation

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000031853
• Date of registration: 23/03/2018
• Prospective Registration: No
• Primary sponsor: Nagasaki University
• Public title: 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 transplantation
• Scientific title: 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 transplantation - A phase 1 investigator-initiated study of TBI-1301-A for refractory ATLL experiencing recurrence after allo-HSCT
• Date of first enrolment: 2018/02/01
• Target sample size: 12
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035766
• Study type: Interventional
• Study design: Single arm Non-randomized
• Phase: Phase I

Countries of recruitment

Japan

Contacts

• Name: Tatsushi Goto
• Affiliation: Secretariat of clinical trial coordinating committee none

• Name: Hiroaki Ikeda
• Affiliation: Graduate School of Biomedical Sciences, Nagasaki University Department of Oncology

Key inclusion & exclusion criteria

Inclusion 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

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

Refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation

Intervention(s)

TBI-1301-A is transfused once after pretreatment by cyclophosphamide

Primary Outcome(s)

Safety - Frequency of occurring adverse event - Frequency of occurring product failure - Appearance of replication competent retrovirus (RCR) - Appearance of clonality

Secondary Outcome(s)

1) Pharmacokinetics of blood TBI-1301-A 2) Clinical effects 3) Transition of laboratory test values 4) Appearance and severity of GVHD

Secondary ID(s)

JapicCTI-183830

Source(s) of Monetary Support

none

Ethics review

Status: YES
Approval date: 22/12/2017
Contact:

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Nagasaki University Hospital IRB

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Results

• Results available: Yes
• Date Completed: 31/01/2021