Clinical trial · Interventional
This is a Phase 1 Study of MH048 in Patients With Selected Relapsed/Refractory B-cell Malignancies
A Phase 1, Multicenter, Open-Label, Dose Escalation and Dose Expansion Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Antitumor Activity of MH048 in Subjects With Selected Relapsed/Refractory B-cell Malignancies
NCT04689308CI-TRIAL-00053765unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 study of MH048 in patients with selected Relapsed/Refractory B-cell Malignancies.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory B-cell Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MH048 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part A: Dose Escalation and Determination of RP2D
- description
- Part A: Dose Escalation and determination of RP2D, multiple dose levels of MH048 to be evaluated
- interventionNames
- Drug: MH048
- type
- EXPERIMENTAL
- label
- Part B: Dose Expansion in Selected Relapsed/Refractory B-cell Malignancies
- description
- Part B: Selected relapsed/refractory B-NHL subjects with at least 1 prior systemic OR standard-of-care therapy.
- interventionNames
- Drug: MH048
Primary outcomes (3)
- measure
- To evaluate the incidence and severity of Treatment-Emergent Adverse Events [Safety and Tolerability]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.