OncoMatch/Clinical Trials/NCT06791681
A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma
Is NCT06791681 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies ESO-T01 for relapsed/ refractory multiple myeloma.
Treatment: ESO-T01 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Biomarker criteria
Required: BCMA (TNFRSF17) expression (expression on MM cells by flow cytometry or immunohistochemistry)
BCMA expression on MM cells determined by flow cytometry or immunohistochemistry
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: anti-myeloma therapy
Previously treated with at least 2 lines of anti-MM therapy, with at least 1 complete treatment cycle for each line, and disease progression within 12 months after the most recent anti-myeloma treatment
Cannot have received: targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices
Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices within 5 half-lives
Cannot have received: immune/non-immune-directed systemic therapy
Received immune/non-immune-directed systemic therapy within 1 week
Cannot have received: cytotoxic therapy
Received cytotoxic therapy within 1 week
Cannot have received: proteasome inhibitor
Received proteasome inhibitors or immunomodulatory agent therapy within 2 weeks
Cannot have received: immunomodulatory drug
Received proteasome inhibitors or immunomodulatory agent therapy within 2 weeks
Cannot have received: radiation therapy
Exception: if the radiation field covered ≤5% of bone marrow reserve, the subject is eligible regardless of the date of radiotherapy completion
Received radiotherapy within 4 weeks (if the radiation field covered ≤5% of bone marrow reserve, the subject is eligible regardless of the date of radiotherapy completion)
Cannot have received: allogeneic hematopoietic stem cell transplant
Received allogeneic HSCT within 6 months prior to infusion
Cannot have received: autologous hematopoietic stem cell transplant
autologous HSCT within 3 months prior to infusion
Cannot have received: viral therapy using VSVG pseudotype virus
Previously treated with any viral therapy using VSVG pseudotype virus
Lab requirements
Blood counts
Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening, recombinant human erythropoietin allowed); ANC ≥ 600/μL (no G-CSF within 1 week or pegylated G-CSF within 2 weeks prior to screening); Platelet count ≥ 50,000/μL; Lymphocyte count ≥ 500/μL; Absolute CD3-positive T cell count ≥ 150/μL
Kidney function
creatinine clearance ≥ 45 mL/min
Liver function
ALT and AST ≤ 3.0 × ULN; TBIL and ALP ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, such as Gilbert's syndrome, where direct bilirubin can be ≤ 1.5 × ULN); Albumin ≥ 3 g/dL
Cardiac function
Left ventricular ejection fraction ≥ 40% (measured by echocardiogram or MUGA scan); No clinically significant pericardial effusion detected; No clinically significant ECG abnormalities detected
Bone marrow function at screening (or within 2 months prior to screening) meets the following criteria: ... Renal function at screening (or within 2 months prior to screening) should be normal, with a creatinine clearance ≥ 45 mL/min; Liver function at screening (or within 2 months prior to screening) must meet the following criteria: ... Cardiac function at screening (or within 2 months prior to screening) must meet the following criteria: ...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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