A Study to Evaluate MTM-H-001 Injection in Adult Participants With Relapsed or Refractory B-cell … (NCT07476378) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
A Study to Evaluate MTM-H-001 Injection in Adult Participants With Relapsed or Refractory B-cell Malignancies
China69 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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:
✓. 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);
Exclusion criteria
✕. B-NHL participants with a history of Richter's transformation of chronic lymphocytic leukemia (CLL).
What they're measuring
1
Incidence of Dose-Limiting Toxicity (DLT)
Timeframe: 42 days following first dose of MTM-H-001 for each participant
Trial details
NCT IDNCT07476378
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
. Primary central nervous system (CNS) lymphoma, or malignant tumors involving the CNS.
✕. Burkitt's lymphoma/leukemia, primary mediastinal large B-cell lymphoma (LBCL).
✕. 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;
✕. Uncontrolled active infection requiring intravenous treatment within one week prior to the first dose;