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:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04689308
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects ≥18 years of age;
2. Willing and able to understand and sign an informed consent form and to comply with all aspects of the protocol;
3. Life expectancy of ≥12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
5. Histologically confirmed B-cell Malignancies who have relapsed or are refractory to standard of care therapies, and have received ≥1 prior lines of therapy:
Part A: Subjects with B-cell Malignancies (regardless of subtype); Part B: Subjects With Selected Relapsed/Refractory B-cell Malignancies based on data from Part A;
6. There must be radiographically measurable disease for effects assess at dose expansion cohort;
7. Adequate organ function, as specified below:
Hematologic: Platelet count \>65 × 10\^9/L (may be posttransfusion, must one week before the first dose of starting study treatment); Hemoglobin (Hgb) ≥ 80 g/L; international normalized ratio (INR) or plasma prothrombin time (PT) ≤1.5 × ULN; absolute neutrophil count \>1.0 × 10\^9/L (growth factor use is allowed to bring pre-treatment neutrophils to \>1.0 × 10\^9 cells/L if bone marrow infiltration is involved, provided this is not within 7 days of starting study treatment); Hepatic: Total bilirubin \<1.5 × upper limit normal (ULN), Total bilirubin \<3 × ULN for Gilbert Syndrome; Aspartate aminotransferase (AST) and Alanine transaminase (ALT) ≤2.5 × ULN; Renal: Creatinine clearance ≥60 mL/min (as estimated by the Cockcroft-Gault equation );
8. Willing to have bone marrow biopsy/aspirate for baseline disease assessment and assessment of response to treatment;
9. Willingness of men and women of reproductive potential to observe conventional and highly effective birth control from the beginning of the study screening until 6 months after receiving the last treatment of investigational product. A fertile woman must be confirmed by a positive serum beta-human chorionic gonadotropin \[β-hCG\] test before 7 days of starting study treatment.
Exclusion Criteria:
1. History of other active malignancies within 1 years of study entry, with the exception of adequately treated in-situ carcinoma of cervix, localized basal cell or squamous cell carcinoma of skin, previous malignancy that was not recurred in 5 years;
2. History of allogeneic or autologous stem cell transplant or chimeric antigen receptor-modified T-cell (CAR-T) therapy within the past 100 days before starting study treatment, or diagnosis of graft vs host disease;
3. Clinically significant, uncontrolled cardiac or cardiovascular disease, or history of myocardial infarction, New York Heart Association (NYHA) Class III or IV, QTc prolongation (defined as a QTc \> 450 ms) or other significant electrocardiogram (ECG) abnormalities including 2nd degree atrioventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate less than 50 beats/min) ,within 6 months prior to planned start of MH048 treatment;
4. Transformation (e.g., Richter's transformation, prolymphocytic leukemia, or blastoid lymphoma) prior to the planned start of MH048 treatment;
5. Subjects with known or suspected history of allergy to MH048 capsules or excipients;
6. Any unresolved toxicities from prior therapy of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v5.0) Grade 2 or higher at the time of starting MH048 treatment, with the exception of toxicities not considered a safety risk (eg, alopecia, neuropathy, or asymptomatic laboratory abnormalities);
7. Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection;
8. Active uncontrolled autoimmune disease;
9. Clinically significant active malabsorption syndrome;
10. Subjects with human immunodeficiency virus (HIV) , Active hepatitis B virus (HBsAg positive, or HBsAg negative/HBcAb positive ，and HBV DNA\>10\^3) or Active HCV infection (HCVAb positive ,and HCV RNA positive);
11. Major surgery within 4 weeks prior to planned start of MH048 treatment (expect for biopsy, laser eye surgery)；
12. Women of childbearing potential who are pregnant or lactating;
13. Subjects requiring therapeutic anticoagulation;
14. Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose of MH048 treatment;
15. Received a CYP3A4, CYP2A8 strong inhibitor or inducer within 5 half-lives of planned investigational product administration；
16. Medical history of massive bleeding (hemophilia or other disease need the treatment of blood transfusion）;
17. Severe neurological/mental illness, and in the opinion of the Investigator, is unable to adhere to the requirements of the study;
18. Receipt of any investigational agent or clinical study within 28 days;
19. Unstable brain metastasis patient.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04689308
Study Brief:
Protocol Section:
NCT04689308