Study of Anitocabtagene-autoleucel in Relapsed or Refractory Multiple Myeloma (iMMagine-1)

Inclusion Criteria:

1. Age 18 years or older and has capacity to give informed consent

2. Relapsed or refractory multiple myeloma treated with at least 3 prior regimens ofsystemic therapy including proteasome inhibitor, immunomodulatory drugs (IMiD) andanti-CD38 antibody and are refractory to the last line of therapy. For each line, 2consecutive cycles are required unless the best response after 1 cycle wasprogressive disease. Note: IMWG criteria defines refractory disease as disease progression on or within 60 days of a therapy Note: Induction treatment with or without hematopoietic stemcell transplant and with or without maintenance is considered a single regimen

3. Documented measurable disease including at least one or more of the followingcriteria:

4. Serum M-protein ≥1.0 g/dL

5. Urine M-protein ≥200 mg/24 hours

6. Involved serum free light chain ≥10 mg/dL with abnormal κ/λ ratio (i.e., >4:1or <1:2)

7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1

8. Life expectancy >12 weeks

9. Adequate organ function defined as:

10. Oxygen (O2) saturation ≥92% on room air

11. Left Ventricular Ejection Fraction (LVEF) ≥45% by echocardiogram (ECHO) ormultigated acquisition (MUGA) scan

12. Absolute neutrophil count (ANC) ≥1.0k/µl, platelet count (PLT) ≥50k/µl, [NOTE: Platelet transfusion not allowed within 14 days; filgrastim (orbiosimilar) not allowed within 7 days, pegfilgrastim (or biosimilar) within 14days]

13. Creatinine clearance ≥45 mL/min min (as determined by the Cockgroft-Gaultequation) and not on dialysis

14. Aspartate transaminase (AST)/alanine transaminase (ALT) <3 x upper limits ofnormal (ULN)

15. Total bilirubin <1.5 x ULN (allow 3x ULN for Gilbert's syndrome)

16. Prothrombin time test (PTT), prothrombin time (PT)/international normalizedratio (INR) <1.5 x ULN, unless on a stable dose of anti-coagulant for athromboembolic event (Subjects with any history of thromboembolic stroke; orhistory or Grade 2 (G2) or greater hemorrhage within one year are excluded)

17. Resolution of adverse events (AEs) from any prior systemic anticancer therapy,radiotherapy, or surgery to Grade 1 or baseline (except G2 alopecia and G2 sensoryneuropathy)

18. Male and female participants of childbearing potential must agree to use highlyeffective methods of birth control through 12 months after the dose of studytreatment

19. Willing to comply with and able to tolerate study procedures, including consent toparticipate in separate Long-term Safety Follow-up lasting up to 15 years per FDAguidance

20. Subject's leukapheresis product from non-mobilized cells is received and acceptedfor cell processing by manufacturing site. NOTE: Leukapheresis will be performedonly after all other eligibility criteria are confirmed

Exclusion Criteria:

1. Plasma cell leukemia or history of plasma cell leukemia

2. Treatment with the following therapies as specified below

3. Any prior systemic treatment for multiple myeloma within the 14 days prior toscheduled leukapheresis

4. Receiving high-dose (e.g., >10 mg prednisone or equivalent) systemic steroidtherapy or any other form of immunosuppressive therapy within 14 days prior toleukapheresis

5. Prior treatment with any gene therapy or gene-modified cellular immune-therapy

6. Prior B-cell maturation antigen (BCMA) directed therapy

7. Autologous stem cell transplantation within 3 months prior to leukapheresis, orany prior allogeneic stem cell transplantation

8. Subjects with solitary plasmacytomas without evidence of other measurable diseaseare excluded

9. History of allergy or hypersensitivity to study drug components. Subjects with ahistory of severe hypersensitivity reaction to dimethyl sulphoxide (DMSO) areexcluded

10. Contraindication to fludarabine or cyclophosphamide

11. Severe or uncontrolled intercurrent illness or laboratory abnormalities including

12. Active bacterial, viral, or fungal infection requiring systemic treatment (isolated fever may not constitute active infection in and of itself, (e.g.,related to disease)

13. Symptomatic congestive heart failure (i.e., New York Heart Association stageIII or IV)

14. Unstable angina, arrhythmia, or myocardial infarction (MI) within 6 monthsprior to Screening

15. Significant pulmonary dysfunction

16. Uncontrolled thromboembolic events or recent severe hemorrhage (i.e., withinone year)

17. Any history of pulmonary embolism (PE) in the past 12 months or deep veinthrombosis (DVT) within three months of enrollment. Therapeutic dosing ofanticoagulants (e.g., warfarin, low molecular weight heparin, Factor Xainhibitors) is allowed for history of PE/DVT if greater than twelve and threemonths, respectively, from time of enrollment, and should be at a stablemaintenance dose.

18. Auto-immune disease requiring immunosuppressive therapy within the last 24months

19. Seropositive for and with evidence of active hepatitis B or C infection at time ofScreening, or HIV seropositive

20. Subjects with a history of hepatitis B but have received antiviral therapy andhave non-detectable viral DNA are eligible

21. Subjects seropositive because of hepatitis B virus vaccine with no signs oractive infection are eligible

22. Subjects who had hepatitis C but have received antiviral therapy and show nodetectable hepatitis C virus (HCV) viral RNA are eligible

23. Active central nervous system (CNS) involvement by malignancy

24. Any sign of active or prior CNS pathology including but not limited to history ofepilepsy, seizure, paresis, aphasia, stroke, subarachnoid hemorrhage or CNS bleed,severe brain injury, dementia, cerebellar disease, Parkinson's disease, organicbrain syndrome or psychosis

25. Active malignancy not related to myeloma that has required therapy in the last 3years or is not in complete remission. Exceptions to this criterion includesuccessfully treated non-metastatic basal cell or squamous cell skin carcinoma, orprostate cancer that does not require therapy.

26. Females who are pregnant or breastfeeding or females of childbearing potential notusing an effective method of birth control

27. Subjects with any significant medical condition, laboratory abnormality, orpsychiatric illness that would prevent the subject from participating in study (orfull access to medical records) as written including follow up, the interpretationof data or place the subject at unacceptable risk

28. Any vaccine ≤ 6 weeks before leukapheresis and/or anticipation of the need for sucha vaccine during the subject's participation in the study

29. Concurrent enrollment on another study using an investigational therapy for thetreatment of RRMM