Study of HBI0101 (NXC-201) CAR-T Therapy in Multiple Myeloma and Light-Chain Amyloidosis

Inclusion Criteria:

1. ≥18 years of age at the time of signing informed consent.

2. Voluntarily signed informed consent form.

3. Diagnosis of multiple myeloma and/or light-chain amyloidosis with relapsed orrefractory disease, with measurable disease at screening visit

4. Subject suffering from multiple myeloma must have been exposed to at least two priorlines of therapy including proteasome inhibitor, immunomodulatory (IMiDs) therapy oranti-CD38 antibody, or functionally high-risk patients (i.e. first relapse within 18months of treatment initiation) may be included. Subject with amyloidosis must have been exposed to at least one prior line oftherapy which includes proteasome inhibitor or anti-CD38 antibody, or subjects withinsufficient response (i.e. not achieving a VGPR or CR after exposure to at least ananti-CD38 antibody and a proteasome inhibitor) may be included.

5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.

6. Women of child-bearing potential (WCBP), defined as a sexually mature woman who hasnot undergone a hysterectomy or tubal ligation or who has not been naturallypostmenopausal for at least 24 consecutive months, must have a negative serumpregnancy test prior to treatment. All sexually active WCBP and all sexually activemale subjects must agree to use effective methods of birth control throughout thestudy.

7. Recovery to ≤ Grade 2 or baseline of any non-hematologic toxicities due to priortreatments, excluding alopecia and Grade 3 neuropathy.

8. Ability and willingness to adhere to the study visit schedule and all protocolrequirements.

9. Subjects with relapsed multiple myeloma who have previously undergone allogenic stemcell transplantation must have no evidence of graft versus host disease aftercessation of any immunosuppressive therapy for at least one month before recruitmentto the study.

Exclusion Criteria:

1. Contraindication to a study treatment/procedure or is anticipated to receivetreatment/procedure that may preclude performance of study procedures.

2. Known bulky central nervous system disease.

3. Inadequate hepatic function defined by aspartate aminotransferase (AST) and/oralanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) and directbilirubin > 4x ULN.

4. Inadequate renal function defined by serum creatinine clearance/estimated clearanceof <20(ml/min).

5. International ratio (INR) or partial thromboplastin time (PTT) > 2 x ULN, unless ona stable dose of anticoagulant for a thromboembolic event (provided this event isnot an exclusion criteria).

6. Inadequate bone marrow function defined by absolute neutrophil count (ANC) < 1000cells/mm^3, platelet count < 30,000 mm^3, or hemoglobin < 8 g/dL. Subjects withabsolute lymphocyte count < 300 cells/mm^3 may be excluded (due to potentialchallenges with producing CART cells), per investigator judgement.

7. Echocardiogram with left ventricular ejection fraction < 40%.

8. Ongoing treatment with chronic immunosuppressant such as cyclosporine or systemicsteroids (physiological replacement doses of steroids are allowed up to 12 mg/m^2/dhydrocortisone or equivalent)

9. Significant co-morbid condition or disease which in the judgment of the Investigatorwould place the subject at undue risk or interfere with the study; examples include,but are not limited to, cirrhotic liver disease, sepsis, recent significanttraumatic injury, and other conditions.

10. Known human immunodeficiency virus (HIV) positive status.

11. Active Hepatitis B or Hepatitis C active infection.

12. Active CMV infection.

13. Known history of stroke, unstable angina, myocardial infarction, or ventriculararrhythmia requiring medication or mechanical control within 3 months.

14. Chronic atrial fibrillation with uncontrolled heart rate.

15. Second primary malignancies that has required therapy in the last 2 years or is notin complete remission.

16. Subjects who have had a venous thromboembolic event (e.g., pulmonary embolism ordeep vein thrombosis) requiring anticoagulation and who meet any of the followingcriteria:

17. Have been on a stable dose of anticoagulation for < 1 month (except for acuteline insertion induced thrombosis.)

18. Have had a Grade 2, 3, or 4 hemorrhage in the last 30 days

19. Are experiencing continued symptoms from their venous thromboembolic event (e.g. continued dyspnea or oxygen requirement).

20. Pregnant or lactating women.

21. Participation in another interventional clinical trial within 30 days prior toscreening visit.