Immune cell therapy in Relapsed or Refractory Multiple Myeloma

Phase 1

Recruiting

Conditions: Multiple myeloma in relapse.
Multiple myeloma in relapse
C90.02

Registration Number: IRCT20200413047063N4

Lead Sponsor: Tehran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1.Age 18-80 years with expected survival > 3 months.
2.Confirmed diagnosis of active multiple myeloma with detectable BCMA expression in malignant cells.
3.Relapsed or refractory disease with at least 2 prior lines of treatment, including a proteasome inhibitor and immunomodulator, without achieving significant efficacy.
4.Measurable disease at screening according to IMWG criteria, as defined by any of the following: Serum monoclonal paraprotein (M-protein) level =1.0 g/dL or urine M-protein level being as defined; or light chain MM without measurable disease in the serum or the urine; serum immunoglobulin free light chain disease dL and abnormal serum immunoglobulin kappa/lambda free light chain ratio.
5.ECOG performance status of 0-1.
6.Acceptable cardiac, liver, and kidney function.
7.Signed written informed consent.

Exclusion Criteria

1.Pregnant or lactating women.
2.Uncontrolled active infection, HIV infection, or positive syphilis serology reaction.
3.Active hepatitis B or hepatitis C infection.
4.Recent or current use of glucocorticoids or other immunosuppresses.
5.Severe cardiac, liver, renal insufficiency, diabetes, or other diseases.
6.Participation in other clinical research in the past three months.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of dose-limiting toxicity (DLTs). Timepoint: Daily during the first seven days after the injection and then weekly until 4 weeks. Method of measurement: History, Physical exam, and lab test.;Overall Remission Rate (ORR). Timepoint: 8 weeks after CAR-NK cells infusion. Method of measurement: Assessed using International Myeloma Working Group (IMWG) criteria.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS). Timepoint: 48 weeks after CAR-NK cells infusion. Method of measurement: Assessed using IMWG criteria.;Duration of Response (DOR). Timepoint: 48 weeks after CAR-NK cells infusion. Method of measurement: Assessed using IMWG criteria.