Multiple myeloma
Conditions
Interventions
Interventions:Immune cells refer to immune cells engineered through techniques such as gene modification and gene knockout, expressing chimeric antigen receptors (CARs) on their surface. Sources of im
Sponsors
People's Liberation Army The General Hospital of Western Theater Command
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be eligible for inclusion: 1.Diagnosed with multiple myeloma with no effective treatment options (such as autologous or allogeneic stem cell transplantation) and limited prognosis with current therapies (12 weeks. 4.Diagnosis of multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies. 5.Patients who have failed chemotherapy for multiple myeloma. 6.Patients with relapsed multiple myeloma. 7.ALT, AST 50%. 10.Treatment failure with autologous or allogeneic stem cell transplantation. 11.Not suitable for stem cell transplantation or unwilling to undergo transplantation due to logistical constraints. 12.Able to undergo venous blood sampling without contraindications to other leukocyte depletion procedures. 13.Able to comprehend and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women, or women planning pregnancy within six months. 2.Infectious diseases (such as HIV, active tuberculosis, etc.). 3.Active hepatitis B or hepatitis C infection. 4.Feasibility assessment screening showing transduction of target lymphocytes <10% or inadequate expansion (<5-fold) under CD3/4-1BB co-stimulation. 5.Abnormal vital signs and inability to cooperate with examinations. 6.Patients with mental or psychological disorders unable to comply with treatment and efficacy assessment. 7.Highly allergic individuals or those with a history of severe allergies, especially to IL-2. 8.Subjects requiring antimicrobial therapy due to systemic or severe local infections. 9.Impairment of essential organ function such as heart, lungs, or brain. 10.Subjects with severe autoimmune diseases. 11.Patients deemed ineligible for treatment due to other reasons by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR);Duration of relief(DOR);Progression-free survival(PFS);Overall survival(OS); | — |
Countries
China
Contacts
Public ContactFan Fangyi
Department of Hematology, People's Liberation Army The General Hospital of Western Theater Command
Outcome results
None listed