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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.

Early Phase 1RecruitingChunrui LiNCT06791681Data as of May 2026

Treatment: ESO-T01This 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.

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Extracted 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

Min 2 prior lines

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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