A Study to Evaluate MTM-H-001 Injection in Adult Participants With Relapsed or Refractory B-cell Malignancies

NCT07476378 | Not Yet Recruiting

• 1 other identifier: MTM-H-001-001
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphoma, Large B-Cell, Diffuse (DLBCL); Lymphoma, Follicular; Lymphoma, Mantle-Cell; Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL); Lymphoma, B-Cell, Marginal Zone; Transformed Follicular Lymphoma (TFL)

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicity (DLT)

  Percentage of participants experiencing DLTs

  42 days following first dose of MTM-H-001 for each participant

Secondary Outcomes (7)

• Objective response rate (ORR)

  Throughout the study, up to 24 months

• Disease control rate (DCR)

  Throughout the study, up to 24 months

• Time to response (TTR)

  Throughout the study, up to 24 months

• Duration of response (DOR)

  Throughout the study, up to 24 months

• Event-free survival (EFS)

  Throughout the study, up to 24 months

Study Arms (1)

Experimental group

EXPERIMENTAL

Part A: Dose Escalation Part, MTM-H-001 Injection, 4 dose groups are planned. The study treatment period includes an induction phase and a maintenance phase. Part B: Dose Expansion Part, MTM-H-001 Injection, 3 dose cohorts are planned. The dose and frequency for each cohort will be determined based on the safety, PK, and PD data of participants from the dose groups in Part A

Drug: MTM-H-001 Injection

Interventions

MTM-H-001 Injection DRUG

Each participant receives MTM-H-001 Injection

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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;
• 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;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• MagicTime Medicine: collaborator

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Langfang, Hebei, 065000, China

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell, Marginal Zone

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell

Study Officials

• Ning Li, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Green

CONTACT

716-474-6710; michaelgreen@magictimemed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)