Active, not recruitingNCT03155191TBI-1501Updated Nov 20, 2024

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

A Phase 1/2 interventional study of TBI-1501 in Lymphoblastic Leukemia, Acute Adult, sponsored by Takara Bio Inc.. Active, not recruiting at 11 sites in Japan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-11-20.

Sponsored by Takara Bio Inc. · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 21
Allocation: Not applicable
Ages: 16 Years and older
Sex: All

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.

Read the 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.

Conditions studied

Lymphoblastic Leukemia, Acute Adult

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Keywords

Acute lymphoblastic leukemia
Leukemia
Lymphoblastic
TBI-1501
Anti-CD19 CAR Expressing T cells Therapy
CD19 CAR Gene-Transduced Lymphocyte
Adoptive Immunotherapy
Genetically Engineered Lymphocyte Therapy
Retroviral Vector
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Experimental
Immune System Diseases
Chimeric antigen receptor

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's planned enrollment of 21 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

Takara Bio Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 16 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

In phase-1 study, patients must be ≥ 18 years of age. In phase-2 study, patients must be ≥ 16 years of age.
Patients with relapse or refractory CD19+ acute B-cell lymphoblastic leukemia
Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
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%
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

Exclusion Criteria:

White blood cell counts ≧ 50,000/uL
Received expected antitumor therapy (chemotherapy or radiation therapy, etc) within 2 weeks.
Received HSCT within 12 weeks before enrollment.
Under treatment for GVHD.
lymphocytes except for blasts ≦ 500/uL
Presence of active CNS-3
Concurrent use of systemic steroids or immunosuppressive agents (except for replacement therapy and local administration. e.g. inhalation, application and so on).
HBs Ag positive ,or either HBc Ab positive or HBs positive with HBV-DNA > 1.3LogIU/ml
Presence of active hepatitis C infection
HIV Ab or anti-HTLV-1 Ab positive
History of allergy about component of investigational product or animal(cattle and/or mouse)-derived additives
Hypersensitivity to antibiotics.
Presence of symptomatic cardiac arrhythmias or serious heart disease.
Presence of another malignant tumor.
Psychiatric disorder, alcohol addiction or drug addiction that affects the ability of informed consent.
Active or serious infection.
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.
Pregnant or lactating women.
Any other patients judged by the investigators to be inappropriate for the study.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 21 participants (estimated)

Study arms

Experimental
Dose Level -1 to 2
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. cohort -1: 3×10\^5 cells/kg cohort 1: 1×10\^6 cells/kg cohort 2: 3×10\^6 cells/kg.
Biological: TBI-1501

Interventions

BiologicalTBI-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.

What researchers measure

Primary outcomes

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

Study locations

11 sites

University Of Fukui Hospital
Yoshida, Fukui 910-1193, Japan
Kyushu University Hospital
Higashi-ku, Fukuoka 812-8582, Japan
Hokkaido University Hospital
Sapporo-shi, Hokkaido 060-8648, Japan
Kobe City Medical Center General Hospital
Kobe, Hyogo 650-0047, Japan
Mie University Hospital
Tsu-shi, Mie 514-8507, Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574, Japan
Jichi Medical University hospital
Shimotsuke-shi, Tochigi 329-0498, Japan
Cancer Institute Hospital Of JFCR
Kōto, Tokyo 135-8550, Japan
The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo 108-8639, Japan
Akita University Hospital
Akita, 010-8543, Japan
Okayama University Hospital
Okayama, 700-8558, Japan

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03155191
Lead sponsor: Takara Bio Inc.
Responsible party: Sponsor
First posted: May 16, 2017
Start date: Jun 1, 2017
Primary completion: Mar 31, 2035 (estimated)
Completion: Mar 31, 2035 (estimated)
Last update: Nov 20, 2024

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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