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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT06465160
Eligibility Criteria:
Inclusion Criteria:
1. Male or female participants aged from 18 years old and above.
2. Low Risk MDS diagnosis with R-IPSS score of ≤3 with mutational burden and/or low burden of high-risk mutations as defined by IPSS-M.
3. Participant has anemia and is blood transfusion dependent (received 2 or more units of packed blood per /4 weeks for at least 8 weeks before enrollment).
4. A baseline natural history of the participant is available, including anemia and transfusions frequency at least 6 months before enrollment.
5. Participant has utilized all existing treatments for low risk MDS that are approved and available to him or is not medically eligible for those treatment options.
6. Participant is not eligible for Allogeneic Bone Marrow Transplantation.
7. Participant is medically able to undergo the study interventions, as determined by the investigator.
8. Participant and/or legal guardian(s) able to understand and provide voluntary written informed consent.
Exclusion criteria:
1. History of infection with HIV-1, HIV-2, or HTLV I/II.
2. Current active infection with HBV , HCV, HTLV I/II, Treponema Pallidum or HIV I-II.
3. Participant is unable to undergo apheresis.
4. Participant has known hypersensitivity to murine proteins or iron-dextran.
5. Participant has chronic severe infection.
6. Participant has disease or condition that may risk the participant or interfere with the ability to interpret the study results.
7. History of treatment for malignant disease (other than excision of non-melanoma skin cancer) in the last 2 years
8. Pregnancy or breastfeeding
9. History of treatment with gene therapy, bone marrow or allogeneic cord blood transplantation.
10. Currently participating in another clinical trial, or participation in another clinical trial within 1 year prior to study enrollment.
11. In the opinion of the Investigator, the participant is unsuitable for participating in the study for any reason.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT06465160
Study Brief:
Protocol Section:
NCT06465160