A Study of ESO-T01 in Treating Relapsed/ Refractory Multiple Myeloma

Inclusion Criteria:

1. Age ≥ 18 years；

2. Diagnosis of multiple myeloma (MM) confirmed according to the IMWG diagnosticcriteria, with BCMA expression on MM cells determined by flow cytometry orimmunohistochemistry;

3. Previously treated with at least 2 lines of anti-MM therapy, with at least 1complete treatment cycle for each line, and disease progression within 12 monthsafter the most recent anti-myeloma treatment, or being refractory to bothimmunomodulatory drugs and proteasome inhibitors, along with disease progressionwithin 2 months after the most recent anti-myeloma treatment (according to the IMWGdiagnostic criteria);

4. Disease must be measurable at screening, meeting at least one of the followingcriteria:Serum M-protein level ≥ 0.5 g/dL; Urinary M-protein level ≥ 200 mg/24h;Serum involved free light chain ≥ 10 mg/dL and an abnormal serum free light chain κ/λ ratio;

5. ECOG score 0-2, with an expected survival time ≥ 3 months;

6. Bone marrow function at screening (or within 2 months prior to screening) meets thefollowing criteria: a.Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1week before screening), recombinant human erythropoietin is allowed; for patientswho meet the ≥6 g/dL criterion at screening, red blood cell transfusion is allowedto maintain hemoglobin ≥ 6 g/dL; b.Absolute neutrophil count (ANC) ≥ 600/μL (no useof granulocyte colony-stimulating factor (G-CSF) within 1 week or pegylated G-CSFwithin 2 weeks prior to screening); c. Platelet count ≥ 50,000/μL; d. Lymphocytecount ≥ 500/μL; e. Absolute CD3-positive T cell count ≥ 150/μL;

7. Renal function at screening (or within 2 months prior to screening) should benormal, with a creatinine clearance ≥ 45 mL/min;

8. Liver function at screening (or within 2 months prior to screening) must meet thefollowing criteria: a. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 3.0 × the upper limit of normal (ULN); b. Total bilirubin (TBIL) and alkalinephosphatase (AKP or ALP) ≤ 2.0 × ULN (except for congenital hyperbilirubinemia, suchas Gilbert's syndrome, where direct bilirubin can be ≤ 1.5 × ULN); c. Albumin ≥ 3g/dL;

9. Cardiac function at screening (or within 2 months prior to screening) must meet thefollowing criteria: a. Left ventricular ejection fraction ≥ 40% (measured byechocardiogram or MUGA scan); b. No clinically significant pericardial effusiondetected; c. No clinically significant ECG abnormalities detected;

10. Pulmonary function at screening (or within 2 months prior to screening) must meetthe following criteria: Oxygen saturation ≥ 90%;No clinically significant pleuraleffusion detected;

11. For women of childbearing potential, a negative pregnancy test must be obtained atscreening and prior to drug infusion, and they must not be breastfeeding;

12. Male and female subjects of childbearing potential must agree to use effectivecontraception from the time of informed consent until 1 year after the study drugadministration;

13. Male and female subjects of childbearing potential must agree not to donate sperm oreggs (oocytes) or other reproductive cells from the time of informed consent until 1year after the study drug administration;

14. The participant or their legally authorized representative must provide writteninformed consent (ICF), indicating their understanding of the purpose and proceduresof the study and their willingness to participate.

Exclusion Criteria:

1. Previous anticancer treatment (as determined by the investigator): a. Receivedtargeted therapy, epigenetic therapy, other investigational drugs, or treatmentusing invasive investigational medical devices within 5 half-lives; b. Receivedimmune/non-immune-directed systemic therapy within 1 week; Received cytotoxictherapy within 1 week; c. Received proteasome inhibitors or immunomodulatory agenttherapy within 2 weeks; d. Received radiotherapy within 4 weeks (if the radiationfield covered ≤5% of bone marrow reserve, the subject is eligible regardless of thedate of radiotherapy completion);

2. Received allogeneic HSCT within 6 months prior to infusion, or autologous HSCTwithin 3 months prior to infusion;

3. Other malignancies prior to screening (except the following): Malignancies treatedwith curative intent and no evidence of active disease ≥2 years before enrollment;Adequately treated non-melanoma skin cancer with no evidence of disease;

4. Previously treated with any viral therapy using VSVG pseudotype virus;

5. Serious uncontrolled infections during screening: Bacterial, viral, fungal, etc.infections;

6. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with elevated peripheral blood HBV DNA levels within 6 months prior toinfusion; Positive for hepatitis C antibody (HCV Ab) with elevated peripheral bloodHCV RNA levels; Positive for HIV antibody; Positive for syphilis;

7. Symptomatic heart failure or significant arrhythmias: NYHA Class III or IVcongestive heart failure; Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent implantation within ≤6 months prior to signing ICF;Clinically significant ventricular arrhythmias or unexplained syncope (except whencaused by vasovagal or dehydration); Significant non-ischemic cardiomyopathyhistory;

8. Other significant diseases: Primary immunodeficiency; Stroke or seizure within 6months prior to screening; Obvious clinical evidence of dementia or altered mentalstatus; History of Parkinson's disease or Parkinsonism;

9. Surgery within 2 weeks prior to treatment or planned surgery within 2 weekspost-treatment, except for local anesthesia procedures;

10. Use of live-attenuated vaccines within 1 month before treatment;

11. Known severe allergic reaction to ESO-T01 or its formulation components;

12. Known severe allergic reaction to Tocilizumab;

13. Inability to establish venous access;

14. Any other condition deemed by the investigator as unsuitable for participation inthe study.