# TBI-1501

Source: https://onco.cc/drugs/tbi-1501/  
OnCo record `tbi-1501` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TBI-1501 is an experimental CAR-T cell therapy from Takara Bio in phase 2 trials for acute lymphoblastic leukaemia, aimed at CD19.

## Summary

TBI-1501 is a CAR-T cell therapy developed by Takara Bio. Its target is CD19. ClinicalTrials.gov describes the intervention as: 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. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, in acute lymphoblastic leukaemia. The largest, NCT03155191, plans to enrol 21 participants with primary completion expected 2035-03-31. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-2
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Modality: CAR-T cell therapy
- Mechanism: CAR-T cell therapy directed at CD19, as stated in the ClinicalTrials.gov intervention record; the detailed mechanism is not stated.

## Sources

- ClinicalTrials.gov: trials of TBI-1501: https://clinicaltrials.gov/search?intr=TBI-1501
- Sponsor page: https://www.takara-bio.com

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/)
- targets: [CD19](https://onco.cc/targets/cd19/)
- companies: [Takara Bio](https://onco.cc/companies/takara-bio/)
- trials: [Study of TBI-1501 for Relapsed or Refractory Acute Lymphoblastic Leukemia](https://onco.cc/trials/nct03155191/)

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JSON: https://onco.cc/api/v1/entities/tbi-1501.json