CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Recruiting· 24 target
Drug / intervention
ESO-T01drug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Age 18 years or older
  • ✓Multiple myeloma confirmed by IMWG criteria with BCMA expression
  • ✓Previously treated with at least 2 lines of anti-MM therapy with disease progression within 12 months, or refractory to both immunomodulatory drugs and proteasome inhibitors with progression within 2 months
  • ✓Measurable disease with serum M-protein ≥0.5 g/dL, urinary M-protein ≥200 mg/24h, or serum involved free light chain ≥10 mg/dL with abnormal κ/λ ratio
Key exclusion· 15
  • ✕Previous treatment with VSV-G pseudotype viral therapy
  • ✕Allogeneic HSCT within 6 months or autologous HSCT within 3 months prior to infusion
  • ✕Other active malignancies (except treated with curative intent ≥2 years prior or non-melanoma skin cancer)
  • ✕Serious uncontrolled infections

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06791681
NCT06791681Early Ph 1RecruitingOn TrackUpdated 16mo ago
CompareCT.gov

Clinical Study for Evaluating ESO-T01 Injection's Safety and Efficacy in Treating Relapsed/refractory Multiple Myeloma

Chunrui Li·interventional·Posted Jan 24, 2025·Updated Feb 11, 2025

In Brief

A Early Phase 1 clinical trial evaluating ESO-T01 for Relapsed/ Refractory Multiple Myeloma. Currently recruiting, targeting 24 participants across 1 site.

Detailed Summary

This is a single center, single arm, open-label, dose-escalation clinical study to observe the safety, tolerability, preliminary efficacy, pharmacokinetics, pharmacodynamics of ESO-T01 injection for treating patients with relapsed/refractory multiple myeloma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRelapsed/ Refractory Multiple Myeloma
CountriesChina
CollaboratorsShenzhen Pregene Biopharma Co., Ltd.

Timeline

Early Ph 1Recruiting
2025202620272028
First PostedJan 24, 2025
Enrollment StartJan 27, 2025
Primary CompletionNov 30, 2027
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 1.4 years agoPrimary completion in 1.4 years

Interventions

ESO-T01drug

ESO-T01 injection is the third-generation self-inactivating lentiviral vector targeting T cells in vivo, which carries a single VHH-directed BCMA-targeted CAR.