Refractory or recurrent multiple myeloma
Conditions
Interventions
Dose escalation phase - low dose group:Infuse 100 × 10^6 CAR+ T cells/per person
Dose escalation phase - medium dose group:Infuse 200 × 10^6 CAR+ T cells/per person
Dose escalation phase - high dose group:Infuse 300 × 10^6 CAR+ T cells/per person
Dose escalation phase:The safe and effective dose of C1801-4V2 cells determined during the dose escalation phase
Sponsors
The First People’s Hospital of Jingzhou
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age = 18 years old, no gender restriction; 2.Multiple myeloma (MM) diagnosed according to IMWG diagnostic criteria, with MM cell BCMA expression confirmed by flow cytometry or bone marrow pathology immunohistochemistry; 3.When filtering, use r/r MM; 4.Received at least second-line treatment for MM (including at least one proteasome inhibitor and one immunomodulatory agent), with disease progression documented by examination data within 12 months of the most recent myeloma treatment; (1) Induction chemotherapy, stem cell transplantation, and maintenance therapy given continuously are considered one line of treatment if there is no disease progression between treatments; (2) Each line of treatment must include at least two complete cycles, unless the best response to the treatment regimen is recorded as disease progression (PD). 5.For screening, the disease must be measurable, which means meeting one of the following criteria: (1) Serum M protein level =0.5 g/dL (=5 g/L); (2) Urine M protein level =200 mg/24h; (3) Involved serum free light chain =10 mg/dL (100 mg/L) with an abnormal serum free light chain ratio; 6.ECOG 0-2 points; 7.Expected survival time is more than 12 weeks; 8.No severe mental disorders; 9.Important organ functions are basically normal: (1) Echocardiography indicates an ejection fraction =50%, and the electrocardiogram shows no significant abnormalities; (2) Creatinine clearance (CrCl) (Cockcroft-Gault formula, Appendix 4) =30 mL/min; (3) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3.0×upper limit of normal (ULN); (4) Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) =2.0×ULN (Gilbert syndrome = 3.0×ULN); (5) Absolute lymphocyte count (ALC) =0.5×10^9/L; absolute neutrophil count (ANC) =1×10^9/L; platelet count (PLT) =50×10^9/L; (6) Prothrombin time (PT) =1.5×ULN, activated partial thromboplastin time (APTT) 92%; 10.Meet the standards for single blood draw or venipuncture, and have no contraindications for cell collection; 11.Men who are fertile and women of childbearing age must agree to use effective contraception from the time of signing the informed consent until 1 year after the use of the investigational drug. Women of childbearing age must have a negative blood pregnancy test at screening and before cell infusion, and must not be breastfeeding. 12.The subject or their guardian agrees to participate in this clinical trial and signs the informed consent form (ICF), indicating their understanding of the purpose and procedures of the clinical trial and their willingness to participate in the study;
Exclusion criteria
Exclusion criteria: 1.History of allergy to any component of the cell product; 2.There is evidence of MM involvement in the central nervous system during screening; 3.Multiple myeloma patients with extramedullary disease (excluding those with a single extramedullary plasmacytoma with a maximum transverse diameter =3 cm); 4.Has any of the following cardiac conditions: (1) New York Heart Association (NYHA) Class III or IV congestive heart failure; (2) Myocardial infarction or coronary artery bypass grafting (CABG) or coronary stent placement within = 6 months prior to signing the ICF; (3) Clinically significant ventricular arrhythmia or history of unexplained syncope (except for vasovagal or dehydration-related cases); (4) History of severe non-ischemic cardiomyopathy; (5) Other cardiac conditions deemed unsuitable for participation by the investigator; 5.Has a history of allogeneic hematopoietic stem cell transplantation, or received autologous hematopoietic stem cell transplantation (ASCT) within 12 weeks prior to leukocyte collection; 6.Patients with other malignancies within the past 3 years prior to screening, excluding those who have undergone curative treatment for malignancies and have had no known active disease for =3 years prior to enrollment, as judged by the investigator to have a low risk of recurrence; or those with adequately treated non-melanoma skin cancer with no current evidence of disease; 7.History of symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months or currently requires anticoagulant therapy; 8.Screen out participants who have participated in other interventional clinical studies within the past 1 month; 9.Vaccinated with live attenuated vaccine within 4 weeks before screening; 10.Stroke or epileptic seizure within 6 months prior to signing the ICF (excluding old lacunar infarcts); 11.Received the following anti-cancer treatments prior to single collection or peripheral blood collection: chemotherapy or targeted therapy within 14 days or at least 5 half-lives (whichever is shorter); 12.Within 1 day before the single collection or peripheral blood collection, there is an active infection requiring systemic treatment or an uncontrolled infection (excluding CTCAE grade 1 genitourinary and upper respiratory infections). 13.Has a chronic disease requiring treatment with systemic corticosteroids or other immunosuppressants, or has received systemic corticosteroids (=20 mg/day prednisone or equivalent doses of other corticosteroids) or other immunosuppressants within 3 days before apheresis or peripheral blood collection, except in the following cases: use of topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment (such as prevention of contrast media allergy); 14.Any of the following conditions apply: (1) Hepatitis B surface antigen (HBsAg) and/or hepatitis B e antigen (HBeAg) positive; (2) Hepatitis B e antibody (HBe-Ab) positive and/or hepatitis B core antibody (HBc-Ab) positive, with HBV DNA copy number greater than the measurable lower limit; (3) Hepatitis C antibody (HCV-Ab) positive; (4) Treponema pallidum antibody (TP-Ab) and TRUST both positive; (5) Human immunodeficiency virus (HIV) antibody test positive; 15.Other researchers believe that it is not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness ;PK;PD;PD;PD;PD; | — |
Countries
China
Contacts
Public ContactTan Jie
The First People’s Hospital of Jingzhou
Outcome results
None listed