Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07362732
Eligibility Criteria:
Inclusion Criteria:
* 1\. Age range: 18-75 years old, gender not limited;
* 2\. Expected survival time exceeds 12 weeks;
* 3\. According to the diagnostic criteria of the International Myeloma Working Group (IMWG) for multiple myeloma, the diagnosis is multiple myeloma (MM), and the expression of BCMA target antigen is confirmed by flow cytometry, bone marrow pathology, and immunohistochemistry.
* 4\. Having measurable multiple myeloma lesions:
* 5\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point;
* 6\. Before screening (at baseline), corresponding conditions should be met;
* 7\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;
* 8\. Those who can understand this experiment and have signed the informed consent form.
Exclusion Criteria:
* 1\. Accompanied by other uncontrolled malignant tumors;
* 2\. Previously received chimeric antigen receptor therapy or other transgenic T cell therapy less than 6 months after the first administration;
* 3\. Have received any anti myeloma treatment (including but not limited to chemotherapy, targeted therapy, immunotherapy, radiation therapy \[excluding local radiotherapy for pain control\], etc.) within 14 days prior to the first use of medication;
* 4\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection;
* 5\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases;
* 6\. Within 14 days prior to enrollment, there is an uncontrolled active infection. Note: If there is no evidence of active infection within 72 hours before enrollment, subjects who continue to use prophylactic antibiotics, antifungal drugs, or antiviral drugs are allowed;
* 7\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression;
* 8\. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial;
* 9\. Unstable pulmonary embolism, deep vein thrombosis, or other significant arterial/venous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment;
* 10\. Long term use of immunosuppressants due to autoimmune diseases or organ transplantation, except for recent or current inhaled corticosteroid therapy;
* 11\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment;
* 12\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07362732
Study Brief:
Protocol Section:
NCT07362732