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 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT07070960
Eligibility Criteria:
Inclusion Criteria:
1. Age between 18 and 70 years (inclusive);
2. Estimated life expectancy of more than 12 weeks;
3. Diagnosis of multiple myeloma confirmed by physical examination, pathological evaluation, laboratory tests, and imaging studies;
4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than 3 times the upper limit of normal (ULN);
5. Karnofsky Performance Status (KPS) score \> 50%.
6. Ineligible for ASCT.
Exclusion Criteria:
1. Pregnant or lactating women, or women planning to become pregnant within the next six months;
2. Transduction efficiency of targeted lymphocytes \<10%, or expansion fold \<5× under CD3/CD28 co-stimulation, as determined by feasibility screening;
3. History of severe allergies or hypersensitivity, especially to interleukin-2 (IL-2);
4. Significant dysfunction of vital organs including the heart, lungs, or brain;
5. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07070960
Study Brief:
Protocol Section:
NCT07070960