Venetoclax-containing Therapy Combined With Microtransplant for Intermediate-risk and Higher MDS

Inclusion Criteria:

• Age >=18 years, male or female, non-limited by race or ethnicity.

• Confirmed diagnosis of MDS according to the World Health Organization (WHO) 5thedition classification, based on histopathology and cytogenetics.

• Risk stratification according to the Revised International Prognostic Scoring System (IPSS-R) must place the patient in the intermediate-, high-, or very high-riskcategory.

• Not candidates for or refuse allogeneic hematopoietic stem cell transplantation.

• Adequate hepatic function including alanine transaminase (ALT) and aspartateaminotransferase (AST )<= 3 × upper limit of normal(ULN), and total bilirubin <= 1.5 × ULN.

• Adequate renal function including serum creatinine <= 2 × ULN or CrCl>= 40mL/min.

• LVEF measured by echocardiogram is within the normal range (LVEF > 50%).

• The subject must have one donor who is >= 18 years old and HLA matched at 0-7/10loci (i.e., at least 3 HLA loci must be mismatched). In addition, the donorvoluntarily donates hematopoietic stem cells and signs the consent form.

• Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research,and is willing to participate in research.

• Donor inclusion criteria: The donor meets the institution's criteria for relatedperipheral blood hematopoietic stem cell donors. The donor must be able to toleratethe cell separation and collection process, and sign the Informed Consent Form.

Exclusion Criteria:

• Uncontrolled infection or hemorrhage.

• Cardiovascular disease with clinical significance, such as uncontrolled or highlysymptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarctionwithin 6 months prior to screening, or New York Heart Association (NYHA) functionclass 3 (moderate) or class 4 (severe) heart disease.

• Uncontrolled autoimmune disease or requiring immunosuppression treatment.

• History of severe blood infusion reaction.

• Nursing women, women of childbearing potential with positive urine pregnancy test,or women of childbearing potential who are not willing to maintain adequatecontraception.

• Psychiatric disorder or cognitive impairment that in the researcher's judgment wouldmake the subject not likely to adhere to the protocol requirements.

• Major surgery within 4 weeks prior to enrollment.

• Life-threatening illness other than MDS or uncontrolled intercurrent illness.