A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

Inclusion Criteria:

• Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnosticcriteria

• Relapsed/refractory multiple myeloma as defined by:

1. Received at least 3 prior lines of MM treatment (must include a PI, an IMiD,and an anti-CD38 antibody).

2）Disease progression within 12 months of the most recent anti-MM therapy; ordisease progression within the past 6 months and subsequently lack response to themost recent line of therapy.

• Measurable disease at screening as defined by any of the following:

1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-proteinlevel ≥200 mg/24 hours; or

2. Light chain multiple myeloma without measurable disease in the serum or theurine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serumimmunoglobulin kappa lambda free light chain ratio.

• Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must beGPRC5D expression positive if previously received BCMA targeted therapy

• ECOG 0-1

• Expected life expectancy exceeds 12 weeks

• Adequate bone marrow reserve or organ function meeting the following criteria:

1. Hemoglobin ≥ 70 g/L

2. Platelet count ≥ 50 × 10^9/L

3. Absolute lymphocyte count ≥ 0.3×10^9/L

4. Absolute neutrophil count ≥ 1.0 × 10^9/L

5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 timesthe upper limit of normal (ULN)

6. Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia (such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN isrequired)

7. Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).

8. corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5mg/dl (≤1.6 mmol/L)

9. SpO2>92% on room air

10. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram;no clinically meaningful pericardial effusion by ultrasound

Exclusion Criteria:

• Solitary plasmacytoma

• Known active central nervous system (CNS) involvement or exhibits clinical signs ofCNS involvement of multiple myeloma.

• Received allogeneic stem cell transplant; received autologous stem cell transplantwithin 12 weeks before screening

• Active second primary malignant tumor, exclude the following: cured non- melanomaskin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal orlobular carcinoma in situ of the breast

• Any other significant medical disease, abnormality, or condition that, in theinvestigator judgment, may make the patient unsuitable for participation in thestudy or put the patient at risk.

• Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary ALamyloidosis.