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Active, not recruiting Phase 1/2

Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT03155191 · tracked via the Priya Life Science Japan tracker
Phase
Phase 1/2
Started
2017-06-01
Last updated
2024-11-20

Condition(s) studied

Lymphoblastic Leukemia, Acute Adult

Investigational drug(s) / intervention(s)

TBI-1501

TBI-1501: Phase-I portion: Cyclophosphamide is administered for conditioning medication of TBI1501, that is CD19-CAR-T cells, (cohort -1: 3×10\^5 cells/kg, cohort 1: 1×10\^6 cells/kg, cohort 2: 3×10\^6 cells/kg). Phase-II portion: Recommended dose of Phase-II part will be administered. Cyclophosphamide will be administered as conditioning. The end of study will be Week 52 after administration of TBI-1501.

Study 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.

Eligibility

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. In phase-1 study, patients must be ≥ 18 years of age. In phase-2 study, patients must be ≥ 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 ≤1.5xULN (Upper limit of normal) * AST(GOT)/ALT(GPT) level ≤5.0xULN * Serum creatinine ≤2.0mg/dL * SpO2 ≧ 92% * LVEF ≥50% 5. Patients must be able to understand and willing to sign a written informed consent document (for patients \<20 years of age their legal guardian must give informed consent). Exclusion Criteria: 1. White blood cell counts ≧ 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 ≦ 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 \> 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.

Primary outcome measure(s)

  • Phase-I portion: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 — One year
    Adverse event (frequency, seriousness, duration, causality, severity, classification), mortality, severe adverse event, discontinuation due to adverse event.
  • Phase-II portion: Anti-tumor effect (CR+CRi rate) — 56 days
    Complete Remission (CR)+Complete Remission with Incomplete Blood Count Recovery (CRi) , as determined by assessments of peripheral blood and bone marrow.

Trial sites (11)

FacilityCityRegionStatus
Akita University Hospital Akita Akita
University Of Fukui Hospital Yoshida Fukui
Kyushu University Hospital Higashiku Fukuoka
Hokkaido University Hospital Sapporo Hokkaido
Kobe City Medical Center General Hospital Kobe Hyōgo
Mie University Hospital Tsu Mie-ken
Tohoku University Hospital Sendai Miyagi
Okayama University Hospital Okayama Okayama-ken
Jichi Medical University hospital Shimotsuke-shi Tochigi
Cancer Institute Hospital Of JFCR Kōto Tokyo
The Institute of Medical Science, The University of Tokyo Minato-ku Tokyo
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03155191 on ClinicalTrials.gov ↗ ← All trials in Japan