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:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT07100067
Eligibility Criteria:
Inclusion Criteria:
* Subjects voluntarily participate in clinical research.
* Age ≥18 years old.
* Eastern Cooperative Oncology Group (ECOG) score 0-2.
* Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria.
* Measurable lesions were present.
* Subjects have received treatment with one PI, one IMiD and a CD38 monoclonal antibody.
* Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria).
* Expected survival ≥3 months.
* Clinical laboratory values in the screening period meet criteria.
Exclusion Criteria:
* Received previous therapy targeting FcRH5 targets.
* Prior antineoplastic therapy and meet exclusion criteria (before apheresis);
* Subjects had Plasma cell leukemia, Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.
* Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;
* Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.
* Serious underlying diseases were present.
* Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.
* Also enrolled in other clinical studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07100067
Study Brief:
Protocol Section:
NCT07100067