An open clinical study on the safety and efficacy of CAR-T cell therapy for relapsed and refractory multiple myeloma
- Conditions
- Multiple myeloma
- Registration Number
- ChiCTR2400088696
- Lead Sponsor
- People's Liberation Army The General Hospital of Western Theater Command
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Subjects must meet all of the following criteria to be eligible for inclusion:<br><br>1.Diagnosed with multiple myeloma with no effective treatment options (such as autologous or allogeneic stem cell transplantation) and limited prognosis with current therapies (<2 years).<br>2.Aged 18-70 years.<br>3.Expected survival >12 weeks.<br>4.Diagnosis of multiple myeloma confirmed by physical examination, pathological examination, laboratory tests, and imaging studies.<br>5.Patients who have failed chemotherapy for multiple myeloma.<br>6.Patients with relapsed multiple myeloma.<br>7.ALT, AST < 3 times the upper limit of normal.<br>8.Bilirubin < 2.0 mg/dl.<br>9.Karnofsky Performance Status (KPS) >50%.<br>10.Treatment failure with autologous or allogeneic stem cell transplantation.<br>11.Not suitable for stem cell transplantation or unwilling to undergo transplantation due to logistical constraints.<br>12.Able to undergo venous blood sampling without contraindications to other leukocyte depletion procedures.<br>13.Able to comprehend and voluntarily sign the informed consent form.
1.Pregnant or lactating women, or women planning pregnancy within six months.<br>2.Infectious diseases (such as HIV, active tuberculosis, etc.).<br>3.Active hepatitis B or hepatitis C infection.<br>4.Feasibility assessment screening showing transduction of target lymphocytes <10% or inadequate expansion (<5-fold) under CD3/4-1BB co-stimulation.<br>5.Abnormal vital signs and inability to cooperate with examinations.<br>6.Patients with mental or psychological disorders unable to comply with treatment and efficacy assessment.<br>7.Highly allergic individuals or those with a history of severe allergies, especially to IL-2.<br>8.Subjects requiring antimicrobial therapy due to systemic or severe local infections.<br>9.Impairment of essential organ function such as heart, lungs, or brain.<br>10.Subjects with severe autoimmune diseases.<br>11.Patients deemed ineligible for treatment due to other reasons by the physician.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate(ORR);Duration of relief(DOR);Progression-free survival(PFS);Overall survival(OS);
- Secondary Outcome Measures
Name Time Method