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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT06379451
Eligibility Criteria:
Inclusion Criteria:
1. Age range from 18 to 70 years old;
2. Expected survival time\>12 weeks;
3. Diagnosed as multiple myeloma through physical examination, pathological examination, laboratory examination, and imaging;
4. Difficult to treat multiple myeloma patients;
5. Patients with recurrent multiple myeloma;
6. ALT, AST\<3 times normal; Bilirubin\<2.0mg/dl;
7. Quality of Life Score (KPS)\>50%;
8. The patient has no serious diseases such as heart, liver, or kidney;
9. Recurrence or no remission of the disease after hematopoietic stem cell transplantation or cellular immunotherapy;
10. Inappropriate conditions for stem cell transplantation or abandonment of transplantation due to limitations in conditions;
11. Blood can be taken intravenously without any other contraindications for leukocyte removal surgery;
12. Can understand and voluntarily sign a written informed consent form.
Exclusion Criteria:
1. Pregnant or lactating women, or women with pregnancy plans within six months;
2. Infectious diseases (such as HIV, active tuberculosis, etc.);
3. Active hepatitis B or hepatitis C infection;
4. Feasibility assessment screening proves that the transfection of targeted lymphocytes is less than 10% or the amplification is insufficient (\<5-fold) under the co stimulation of CD3/CD28;
5. Abnormal vital signs and inability to cooperate with the examination;
6. Individuals with mental or psychological disorders who cannot cooperate with treatment and efficacy evaluation;
7. Highly allergic constitution or a history of severe allergies, especially those who are allergic to IL-2;
8. Subjects with systemic or severe local infections requiring anti infection treatment;
9. Subjects with severe autoimmune diseases;
10. The doctor believes that there are other reasons why patients cannot be included in treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06379451
Study Brief:
Protocol Section:
NCT06379451