A phase 1 investigator-initiated study of TBI-1301-A for refractory ATLL experiencing recurrence after allo-HSCT

Phase 1

Completed

• Conditions: Refractory ATLL experiencing recurrence after allogenic hematopoietic stem cell transplantation

• Registration Number: JPRN-jRCT2080223774
• Lead Sponsor: Dokkyo Medical University, Tokyo University. Nagoya City University, Mie University, Osaka International Cancer Institute, Kyushu University, Nagasaki University, Kagoshima University, Imamura General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 12

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 < 3xULN
AST(GOT), ALT(GPT) < 5xULN
Creatinine < 3xULN
LVEF >=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

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

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>1) Pharmacokinetics of blood TBI-1301-A<br>2) Clinical effects<br>3) Transition of laboratory test values<br>4) Appearance and severity of GVHD