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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 (Jun 2026). This Early Phase 1 trial studies ESO-T01 for relapsed/ refractory multiple myeloma.

Early Phase 1RecruitingChunrui LiNCT06791681Data as of Jun 2026Location: China

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

Treatments studied

Other

ESO-T01

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.

Frequently asked questions

Is NCT06791681 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive investigational medical devices, immune/non-immune-directed systemic therapy, cytotoxic therapy disqualifies patients from enrollment.

Does this trial require TNFRSF17?

Yes, TNFRSF17 expression is a required biomarker for enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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