MTM-H-001 Injection for Adults With Relapsed or Hard-to-Treat B-cell Lymphomas and Leukemia
Tests MTM-H-001 in adults whose B-cell cancers returned or resisted treatment.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate MTM-H-001 Injection in Adult Participants With Relapsed or Refractory B-cell Malignancies
Key facts
- Where
- Langfang, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07476378, who can take part
Where in China
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesLangfang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Trial code
- NCT07476378
- Record updated
- 17 March 2026
- Original description
This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with relapsed/refractory (R/R) B-cell malignancies.Read full original descriptionShow less
An Open-label, Single-arm, Dose-escalation and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in the Treatment of Adult Participants With Relapsed or Refractory B-cell Malignancies (Archonc-001)
This is an investigator-initiated, open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of MTM-H-001 in adult participants with relapsed/refractory (R/R) B-cell malignancies.
Inclusion: Male or female, aged 18 - 75 years old (inclusive); The participant or his/her legally acceptable representative gives consent to this clinical study participation and signs an Informed Consent Form (ICF) indicating their understanding of the objectives and procedures of the clinical study and willingness to participate in the study; Participants with histopathologically and immunohistochemically confirmed Non-Hodgkin B-cell Lymphoma (B-NHL) according to the 2016 World Health Organization (WHO) classification of tumors of hematopoietic and lymphoid tissues (CLL/SLL diagnosed in accordance with 2018 iwCLL criteria); Relapsed or refractory disease after receiving at least two prior lines of standard therapy, or relapsed or refractory disease after receiving autologous hematopoietic stem cell transplant (ASCT) (if applicable); Adequate major organ function, defined as meeting the following criteria:; Hematology: Hemoglobin (Hb) ≥80 g/L; absolute neutrophil count (ANC) ≥1.0×10\^9/L; and platelet count (PLT) ≥75×10\^9/L; Coagulation: International Normalized Ratio (INR) ≤1.5×Upper Limit of Normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×Upper Limit of Normal (ULN); Serum Total Bilirubin (TBIL) ≤1.5×ULN (except for participants with documented Gilbert's syndrome); Blood creatinine (Cre) ≤1.5×ULN, or calculated creatinine clearance (Ccr) ≥50 mL/min (using the Cockcroft-Gault formula); Cardiac function: Good hemodynamic stability, Left Ventricular Ejection Fraction (LVEF) ≥50%; Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2; Expected survival >3 months; Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and agree to use at least one effective contraceptive method throughout the study and within 6 months after the last treatment cycle.
Exclusion: Uncontrolled active infection requiring intravenous treatment within one week prior to the first dose; B-NHL participants with a history of Richter's transformation of chronic lymphocytic leukemia (CLL); Primary central nervous system (CNS) lymphoma, or malignant tumors involving the CNS; Known history of other malignancies within the past 5 years, excluding cured localized tumors (including cervical carcinoma in situ, basal cell carcinoma of the skin, and prostate carcinoma in situ, etc.); Active hepatitis B virus (HBV) infection; Active hepatitis C virus (HCV) infection; Active human immunodeficiency virus (HIV) infection or a past history of HIV infection; History of any mental disorders (e.g., schizophrenia, bipolar disorder, eating disorders, major depression, or anxiety) as reported by the participant or documented in medical records; Corrected QT interval using Fridericia (QTcF) is ≥450 ms (male) or ≥470 ms (female) according to the electrocardiography (ECG) examination results at screening; Currently experiencing or having experienced within the past 6 months any of the following:; Congestive heart failure (New York Heart Association [NYHA] Class III-IV); Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg with medication treatment; Myocardial infarction, clinically significant arrhythmias, unstable angina, Torsades de Pointes, left bundle branch block or bifascicular block, coronary/peripheral artery bypass grafting, congenital long QT syndrome; Cerebrovascular accident, transient ischaemic attack; Symptomatic pulmonary embolism; Burkitt's lymphoma/leukemia, primary mediastinal large B-cell lymphoma (LBCL); Pregnant or breastfeeding women.