Safety and efficacy of TBI-0301 gene-transduced donor lymphocyte infusion in patients with hematological malignancy experiencing recurrence/relapse or aggravation after allogeneic hematopoietic stem-cell transplantatio

Phase 1

• Conditions: hematological malignancy

• Registration Number: JPRN-jRCT2080220900
• Lead Sponsor: Takara Bio Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Patients:
(1)Patients with a diagnosis of relapse, recurrence or aggravation of hematological malignancy after related allogeneic stem cell transplantation
(2)Patients should be > 20 years old
(3)ECOG performance status (PS) 0 to 2
(4)No severe organ damage as measured by:
-Oxygen saturation > 93 % (non-invasive measurement is acceptable)
-AST (GOT) and ALT (GPT) < 5 X ULN
-Total bilirubin and serum creatinine < 3 X ULN
-Physically normal electrocardiogram

Donor:
(1)Original donor of hematopoietic stem cell transplantation
(2)Donor should be > 20, < 65 years old
(3)ECOG performance status (PS) 0
(4)Having a good heart, lung, liver and kidney function
-No ischemic electrocardiographic changes and no arrhythmia requiring treatment on ischemic
-Chest x-ray without evidence of active infection, and arterial oxygen saturation > 93% without oxygen administration (non-invasive measurement is acceptable)
-Serum creatinine < 1.5 mg/dL
-AST (GOT) , ALT (GPT), and total serum bilirubin < 2 X ULN
(5)Having a good hematopoietic capacity
-WBC > 3,000 /microliter, PLT > 130,000 /microliter
-Hb > 13.0 g/dL for men, 11.0 g/dL for women

Exclusion Criteria

Patient:
(1)Relapsed, recurrent or aggravated patients in very early after transplantation who can not expect the effect of donor lymphocyte infusion.
(2)Patients with Epstein-Barr virus- associated lymphoproliferative disorder
(3)Presence of grade II to IV acute GVHD or extensive chronic GVHD
(4)LVEF at rest < 50 %
(5)Patients with central nervous system involvement
(6)Patients with multiple malignancies
(7)Patients with active infection
(8)Ongoing GCV, acyclovir or valacyclovir administration within 24 hours before the infusion of donor lymphocytes transduced with TBI-0301

Donor:
(1)Presence of complication and medical history listed below:
-Autoimmune disease (include collagen disease)
-Phlebothrombosis, arteriosclerotic disease
-Congestive heart failure, ischemic Heart failure, cerebrovascular lesion
-Interstitial pneumonia
-Malignant tumor
(2)Diabetes uncontrollable even with regular insulin use, or uncontrollable hypertension
(3)History of grave drug allergy
(4)Pregnant or lactating women
(5)Any of the HBs antigen, HCV antibody and HIV antibody, and serological test for syphilis positivity
(6)Uncontrollable mental illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified