A Phase III Study of Eque-cel in Subjects with Len-refractory RRMM (FUMANBA-03)

Inclusion Criteria:

1. 18 to 75 years of age (inclusive of critical values), either gender.

2. The subject was previously diagnosed with multiple myeloma and had received 1-2lines of therapy (including chemotherapy regimens based on proteasome inhibitors andimmunomodulatory agents, with each line of therapy receiving at least 1 full cycle ;Documented disease progression during or within 12 months after the most recentanti-myeloma therapy.

3. Subjects was lenalidomide-refractory during prior therapy.

4. ECOG score of 0 or 1.

5. Subjects must have appropriate organ function and meet all of the followinglaboratory test results before enrollment:

(1) Haematology: absolute neutrophil count (ANC) ≥1×10^9/L (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10^9/L; Platelets ≥50×10^9 / L (must not have received platelet transfusion within 7 days prior to laboratory test); Hemoglobin ≥60g/L (must not have received red blood cells transfusion within 7 days prior to laboratory test); (2) Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of upper limit of normal (ULN); Serum total bilirubin ≤1.5 times of ULN; (3) Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml/min; (4) Coagulation: fibrinogen≥1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, pro-thrombin time (PT) ≤ 1.5 × ULN; (5) Pulse oxygen saturation > 91%; (6) Left ventricular ejection fraction (LVEF)≥50%;

6. Subjects agree to use effective tools or drug contraception (excluding safe periodcontraception) after signing the informed consent form.

7. Subjects must agree to sign or personally sign an ethics committee-approved informedconsent form before starting any screening procedures.

Exclusion Criteria:

1. Subjects who have used or required long-term immune-suppressive agents (e.g.,cyclosporine or systemic steroids) within 14 days prior to enrollment, but the useof physiological substitutes, intermittent, topical, and inhaled steroids isallowed.

2. Subjects who have undergone autologous haematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to randomization, or who have previously undergoneallogeneic haematopoietic stem cell transplantation (Allo-HSCT).

3. Subjects received the following anti-tumor treatments before enrollment: (1)Treatedwith an immunomodulator within 7 days, or; (2)Received plasma exchange, radiotherapy (except local radiotherapy for myeloma-related bone lesions), cytotoxicchemotherapy, treatment with proteasome inhibitors or other investigational drugwithin 14 days, or; (3) Treatment with monoclonal antibody for multiple myelomawithin 21 days, or; (4) Received other anti-cancer therapy within 14 days or atleast 5 half-lives (whichever is shorter) prior to enrollment.

4. Significant cardiac disorder.

5. Unstable systemic disease as judged by the investigator: including but not limitedto severe liver, renal, or metabolic disease requiring medication.

6. The subject will not be able to participate in this study if the investigatordetermines that the subject meets any of the following conditions: (1) Subjects witha history of allergic reaction to the excipient components (DMSO and albumin) ofEque-cel, fludarabine, cyclophosphamide, tocilizumab, or; (2) Subjects who areintolerant to dexamethasone, or; (3) Subjects who have a Life-threatening allergy,hypersensitivity reaction, or intolerance to pomalidomide and/or its excipients (intolerance is defined as discontinuation of prior treatment due to any AE relatedto pomalidomide) or;

7. Have malignancies other than multiple myeloma within 5 years before screening,excluding cervical carcinoma in situ after radical surgery, basal cell or squamouscell skin cancer, localized cancer of prostate after radical prostatectomy, breastductal carcinoma in situ after radical mastectomy or carcinoma papillary thyroidafter radical thyroidectomy.

8. Subjects suspected or confirmed to have central nervous system involvement of MMduring the screening period.

9. Subjects with concurrent plasma cell leukemia(defined as plasma cell proportion inperipheral blood > 5%), Waldenström macroglobulinaemia, POEMS syndrome (polyneuropathy, organ hypertrophy, endocrinopathy, monoclonal protein and skinchanges) or primary amyloidosis during screening period.

10. Have extramedullary multiple myeloma-extraosseous (EM-E); have multipleextramedullary multiple myeloma-bone related (EM-B) and the maximum transversediameter of any lesion is >3cm; have a single EM-B and the maximum transversediameter of the lesion is >3cm.

11. Had major surgery within 2 weeks prior to randomization or planned to have surgerywithin 2 weeks after study treatment (except for subjects who were scheduled to havesurgery under local anesthesia).

12. Subject with uncontrollable infection.

13. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positiveand hepatitis B virus (HBV) DNA quantification in peripheral blood was higher thanthe lower limit of detection; hepatitis C virus (HCV) antibody positive andhepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiencyvirus (HIV) antibody positive; Syphilis test positive; positive cytomegalovirus (CMV) DNA.

14. Pregnant or breastfeeding women.

15. The subject has a history of central nervous system disorder within 6 months priorto signing the informed consent form.

16. Non-hematological toxicity reactions due to prior treatment have not resolved tobaseline or ≤ Grade 1 (NCI-CTCAE v5.0, alopecia, Grade 2 peripheral neuropathy wereexcepted).

17. Subjects had other conditions that the investigator considered unsuitable forenrollment.