OncoMatch/Clinical Trials/NCT06691685
A Clinical Study to Evaluate the Safety and Efficacy of ESO-T01 in Treating Relapsed/Refractory Multiple Myeloma.
Is NCT06691685 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies ESO-T01 for multiple myeloma.
Treatment: ESO-T01 — This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability, preliminary efficacy and immunogenicity of ESO-T01 for 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 pathology immunohistochemistry)
BCMA expression on MM cells determined by flow cytometry or pathology 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 evidence of disease progression within 12 months after the most recent anti-myeloma treatment, or being refractory to both immunomodulatory drugs and proteasome inhibitors, with disease progression within 2 months after the most recent anti-myeloma treatment
Cannot have received: targeted therapy
Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices within 5 half-lives
Cannot have received: systemic therapy
Received immune/non-immune-directed systemic therapy within 1 week
Cannot have received: cytotoxic chemotherapy
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 is allowed); ANC ≥ 600/μL (no use of 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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