# FUMANBA-1

Source: https://onco.cc/trials/fumanba-1/  
OnCo record `fumanba-1` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The single-arm trial that won eque-cel its approval in China, with almost every patient responding and most reaching deep remissions.

## Summary

Multicentre single-arm study reported in JAMA Oncology 2024: objective responses in about 96% of infused patients, high rates of stringent complete response and minimal residual disease negativity, durable responses including in patients previously exposed to CAR-T, and mostly grade 1 to 2 cytokine release syndrome. Basis of NMPA approval in June 2023, China's first fully human BCMA CAR-T.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Tags: china
- Registry id: NCT05066646
- Phase: 1/2
- Setting: Relapsed or refractory multiple myeloma after three or more lines, China: single-arm study of equecabtagene autoleucel
- Sponsor: IASO Biotherapeutics and Innovent Biologics
- Enrolled: 103
- Result: ORR about 96% in infused patients (JAMA Oncol 2024).
- Outcomes: Overall response rate (efficacy-evaluable): Equecabtagene autoleucel 1.0 × 10^6 CAR+ T cells/kg 96%; Complete response or better: Equecabtagene autoleucel 74.3%; MRD negativity (10^-5): Equecabtagene autoleucel 95%; Progression-free survival at 12 months: Equecabtagene autoleucel 78.8%; Cytokine release syndrome, any grade: Equecabtagene autoleucel 93.2%
- Replication: Single-arm phase 1b/2 across 14 Chinese centres; no randomised comparison. The response rate sits alongside zevor-cel (LUMMICAR STUDY 1, ORR 92.2%) and cilta-cel (CARTITUDE-1), so the depth of response is consistent across fully human and llama-derived BCMA CAR-Ts; 9 of 12 patients previously exposed to another CAR-T responded.

## Sources

- ClinicalTrials.gov NCT05066646: https://clinicaltrials.gov/study/NCT05066646
- JAMA Oncol 2024: https://doi.org/10.1001/jamaoncol.2024.4879

## Connected records

- cancers: [Multiple myeloma](https://onco.cc/cancers/multiple-myeloma/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [BCMA](https://onco.cc/targets/bcma/)
- drugs: [Equecabtagene autoleucel](https://onco.cc/drugs/equecabtagene-autoleucel/)
- companies: [IASO Biotherapeutics](https://onco.cc/companies/iaso-bio/), [Innovent Biologics](https://onco.cc/companies/innovent/)
- institutions: [Tongji Hospital, Huazhong University of Science and Technology](https://onco.cc/institutions/tongji-hospital-wuhan/)
- key papers: [Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma: The FUMANBA-1 Nonrandomized Clinical Trial](https://onco.cc/key-papers/paper-li-jama-oncol/)

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