a study of kq-2003 car-t cell therapy for patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a multicenter, open-label, dose-escalation/expansion phase 1/2a study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and determine the recommended dose of kq-2003 car t-cells for patients with relapsed/refractory multiple myeloma


Eligibility criteria:
inclusion criteria: * age ≥18 years old, male or female; * diagnosis of mm with relapsed or refractory disease; * eastern cooperative oncology group (ecog) performance ≤2 ; * expected survival of at least 12 weeks; * participant has measurable disease; * adequate venous access for the apheresis of peripheral blood mononuclear cell; * adequate organ function; * able and willing to comply with the study protocol and follow-up plan, and sign the informed consent form in writing. exclusion criteria: * received any treatment that might influence the activity of car-t cells prior to the collection of peripheral blood mononuclear cells; * have history of vaccination within the 4 weeks preceding the collection of peripheral blood mononuclear cells; * have active bleeding or venous thromboembolic events requiring anticoagulation; * have tested positive for cytomegalovirus and/or mycobacterium tuberculosis, or had any uncontrolled active infection within 14 days prior to the collection of peripheral blood mononuclear cells; * subjects infected with active hbv or hcv, hiv, syphilis; * subjects with known central nervous system disease or multiple myeloma involving the central nervous system (cns) or presenting with cns-related symptoms; * patients currently experiencing active autoimmune diseases; * diagnosed with immunodeficiency or receiving any other form of immunosuppressive therapy within 7 days prior to enrollment in this study. * have following severe diseases: unstable angina, cerebrovascular accident or transient ischemic attack, myocardial infarction , new york heart association (nyha) class ≥ iii, congestive heart failure, poorly controlled severe arrhythmias or other cardiac diseases requiring mechanical support; subjects with known chronic obstructive pulmonary disease (copd) with a forced expiratory volume in 1 second (fev1) \< 50% of predicted normal; subjects with known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or currently having any category of uncontrolled asthma; subjects requiring oxygen to maintain adequate oxygen saturation; subjects with hypertension whose blood pressure cannot be lowered to the following range despite treatment with two or more antihypertensive medications;. * subjects with malignancies other than multiple myeloma; * have any non-hematologic toxicity resulting from prior treatments that cannot be restored to ≤ grade 1 or baseline, excluding alopecia and grade 2 neuropathy; * history of alcohol abuse, drug addiction, substance abuse, or mental illness within the past year; * presence of acute graft-versus-host disease (gvhd) or extensive chronic gvhd of grade ≥ 2 requiring treatment within the 4 weeks before enrollment, or as judged by the investigator to likely require anti-gvhd treatment during the study; subjects who had previously received bcma-cd19 dual-target car-t cell products or autologous stem cell transplantation within 12 weeks before the collection of peripheral blood mononuclear cells; * known allergy or hypersensitivity reactions to cyclophosphamide, fludarabine, dimethyl sulfoxide (dmso), cd19, or bcma-targeted drugs; * subjects had participated in other clinical trials and used its investigational drugs within the 3 months prior to the collection of peripheral blood mononuclear cells * pregnant or lactating women * any situation that the investigator believes may increase the risk of subjects or interfere with the results of clinical trials