# TBI-1301

Source: https://onco.cc/drugs/tbi-1301/  
OnCo record `tbi-1301` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

TBI-1301 is an experimental investigational agent whose form is not stated in the registry from Takara Bio in phase 3 trials for sarcomas, with its target not yet stated publicly.

## Summary

TBI-1301 is an investigational agent whose form is not stated in the registry developed by Takara Bio. Its molecular target is not stated in the ClinicalTrials.gov intervention record, and OnCo has not confirmed one from the sponsor's pipeline page. ClinicalTrials.gov describes the intervention as: Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment. It is the investigational product in 1 recruiting or active industry-led phase 2 and phase 3 interventional cancer trial, including the phase 3 study NCT07174427 (Multi-centre Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma), in sarcomas. The largest, NCT07174427, plans to enrol 5 participants with primary completion expected 2032-03. Status reflects the highest phase registered on ClinicalTrials.gov; no efficacy results are recorded here.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-11
- Tags: pipeline; ctgov-ingest
- Modality: TCR-T cell therapy (per the sponsor's pipeline page; form not stated in the registry record)
- Mechanism: Mechanism not stated in the ClinicalTrials.gov record or on the sponsor's pipeline page.

## Sources

- ClinicalTrials.gov: trials of TBI-1301: https://clinicaltrials.gov/search?intr=TBI-1301
- Sponsor page: https://www.takara-bio.com

## Connected records

- cancers: [Sarcomas (soft tissue, bone, GIST)](https://onco.cc/cancers/sarcoma/)
- companies: [Takara Bio](https://onco.cc/companies/takara-bio/)
- trials: [Multi-center Study of TBI-1301 (INN: Mipetresgene Autoleucel; Mip-cel) in Patients With NY-ESO-1 Positive Synovial Sarcoma](https://onco.cc/trials/nct07174427/)

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JSON: https://onco.cc/api/v1/entities/tbi-1301.json