A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia
TBI-1501
Takara Bio Inc.
7-4-38 Nojihigashi, Kusatsu, Shiga
+81-77-565-6976
takara-clinical@takara-bio.co.jp
Takara Bio Inc.
7-4-38 Nojihigashi, Kusatsu, Shiga
+81-77-565-6976
takara-clinical@takara-bio.co.jp
completed
Dec. 08, 2017
21
Interventional
Phase I:
Cyclophosphamide is administered for conditioning medication of TBI1501, that is CD19-CAR-T cells, (cohort -1: 3x10^5 cells/kg, cohort 1: 1x10^6 cells/kg, cohort 2: 3x10^6 cells/kg).
Phase II:
Recommended dose of Phase-II will be administered. Cyclophosphamide will be administered as conditioning. The end of study will be Week 52 after administration of TBI-1501.
treatment purpose
1-2
1.In phase I, patients must be more than 18 years of age. In phase II, patients must be more than 16 years of age.
2.Patients with relapse or refractory CD19+ acute B-cell lymphoblastic leukemia
3.Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
4.Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc), as defined below
- Total bilirubin level more than 1.5xULN (Upper limit of normal)
- AST(GOT)/ALT(GPT) level more than 5.0xULN
- Serum creatinine more than 2.0mg/dL
- SpO2 more than 92%
- LVEF more than 50%
5.Patients must be able to understand and willing to sign a written informed consent document (for patients under 20 years of age their legal guardian must give informed consent).
1.White blood cell counts more than 50,000/uL
2.Received expected antitumor therapy (chemotherapy or radiation therapy, etc) within 2 weeks.
3.Received HSCT within 12 weeks before enrollment.
4.Under treatment for GVHD.
5.lymphocytes except for blasts more than 500/uL
6.Presence of active CNS-3
7.Concurrent use of systemic steroids or immunosuppressive agents (except for replacement therapy and local administration. e.g. inhalation, application and so on).
8.HBs Ag positive ,or either HBc Ab positive or HBs positive with HBV-DNA over 1.3LogIU/ml
9.Presence of active hepatitis C infection
10.HIV Ab or anti-HTLV-1 Ab positive
11.History of allergy about component of investigational product or animal(cattle and/or mouse)-derived additives
12.Hypersensitivity to antibiotics.
13.Presence of symptomatic cardiac arrhythmias or serious heart disease.
14.Presence of another malignant tumor.
15.Psychiatric disorder, alcohol addiction or drug addiction that affects the ability of informed consent.
16.Active or serious infection.
17.Both men and women who have generative functions, and who cannot agree with using contraceptive devices from the day of the consent to the end of study.
18.Pregnant or lactating women.
19.Any other patients judged by the investigators to be inappropriate for the study.
16age old over
No limit
Both
CD19+ B-acute Lymphoblastic Leukemia
investigational material(s)
Generic name etc : TBI-1501
INN of investigational material : -
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : 0.3 to 3 x 10^6 autologous CD19-CAR-T cells/kg per patient will be administered intravenously after a conditioning chemotherapy with cyclophosphamide.
control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -
