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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT07107204
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary participation with signed informed consent by the participant or their legal guardian and being willing and able to comply with all trial procedures.
2. Age:≥18 and \<70 years, any gender.
3. Diagnosis:Confirmed hematologic malignancy (leukemia, lymphoma, or multiple myeloma) .
4. Leukemia-Specific Requirement:Bone marrow blast count ≥5% (morphological) at screening.
5. Measurable Disease.
6. Relapsed/Refractory Status.
7. Adequate organ and hematologic function.
8. An ECOG activity status score of 0-1.
9. A life expectancy of ≥ 3 months.
10. Eligible participants of childbearing potential (both males and females) must agree to using effective contraception throughout the study period.
Exclusion Criteria:
1. Acute promyelocytic leukemia (APL).
2. Patients with hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or any other known bone marrow failure syndrome.
3. Patients with isolated extramedullary leukemia and multiple myeloma.
4. Patients with uncontrolled active central nervous system leukemia (CNSL).
5. Patients who have received anticancer therapy prior to administration.
6. A history of active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years.
7. A history of clinically significant cardiovascular disease, severe cardiac rhythm/conduction abnormalities ,severe pulmonary disease that may lead to severe episodes of dyspnea,head trauma, impaired consciousness, epilepsy, cerebral ischemia, or cerebral hemorrhagic disease.
8. A severe acute or chronic infection when enrollment.
9. Remaining the toxic reaction in previous anti-tumor therapy that has not recovered to ≤ Grade 1 .
10. Unresolved \> grade 1 irAE or the history of a grade ≥ 3 irAE in previous immunotherapy, or known hypersensitivity to the formulation of the investigational product.
11. Patients undergoing acute graft-versus-host disease (GVHD) or moderate-to-severe chronic GVHD or systemic GVHD therapy.
12. A history of other type of malignancies.
13. Received a live attenuated vaccine within 28 days prior to the administration of the investigational product.
14. Poor compliance.
15. A history of alcohol/drugs abuse.
16. Current pregnancy or breastfeeding.
17. Other severe physical or mental illnesses or abnormal laboratory test results that the investigator deems unsuitable for participation in this study considering safety and compliance.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT07107204
Study Brief:
Protocol Section:
NCT07107204