Spots Global Cancer Trial Database for Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
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Trial Identification
Brief Title: Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia
Official Title: A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia
Study ID: NCT03155191
Conditions
Interventions
Study Description
Brief Summary: Evaluate the safety (P-I), pharmacokinetics and anti-tumor effect of immunotherapy of autologous T cells genetically modified to express anti-CD19 chimeric antigen receptor (CAR) (TBI-1501) for relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.
Detailed Description: Enroll patients after confirming eligibility. Following enrollment, peripheral blood mononuclear cells and blood plasma will be obtained from each subject by apheresis to start the manufacturing of TBI-1501. Before TBI-1501 administration, it is necessary to pass the quality tests. Subject will be hospitalized from Day -3 to Day 28, and administered Cyclophosphamide (1,000 mg/m2/day×2 days) on Day -3 and Day -2.
Keywords
Eligibility
Minimum Age: 16 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Of Fukui Hospital, Yoshida, Fukui, Japan
Kyushu University Hospital, Higashi-ku, Fukuoka, Japan
Hokkaido University Hospital, Sapporo-shi, Hokkaido, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Mie University Hospital, Tsu-shi, Mie, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Jichi Medical University hospital, Shimotsuke-shi, Tochigi, Japan
Cancer Institute Hospital Of JFCR, Kōto, Tokyo, Japan
The Institute of Medical Science, The University of Tokyo, Minato-ku, Tokyo, Japan
Akita University Hospital, Akita, , Japan
Okayama University Hospital, Okayama, , Japan
Contact Details
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