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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL); Lymphoma, Large B-Cell, Diffuse (DLBCL); Transformed Follicular Lymphoma (TFL)
• Intervention / Treatment: Drug: MTM-H-001 Injection

• Study Type: Interventional
• Enrollment (Estimated): 69
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Green; Phone Number: 716-474-6710; Email: michaelgreen@magictimemed.com

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China, 065000
      • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Contact: Ning Li, Ph.D; Phone Number: +86-010-87788713; Email: Lining@cicams.ac.cn
      • Contact: Yale Jiang; Phone Number: +86-13261010586; Email: yalejiang@cicams.ac.cn
      • Principal Investigator: Ning Li, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female, aged 18 - 75 years old (inclusive);
2. 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;
3. 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)
4. 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).

5. Adequate major organ function, defined as meeting the following criteria:

   1. Hematology: Hemoglobin (Hb) ≥80 g/L; absolute neutrophil count (ANC) ≥1.0×10^9/L; and platelet count (PLT) ≥75×10^9/L;
   2. Coagulation: International Normalized Ratio (INR) ≤1.5×Upper Limit of Normal (ULN) and Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN;
   3. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×Upper Limit of Normal (ULN);
   4. Serum Total Bilirubin (TBIL) ≤1.5×ULN (except for participants with documented Gilbert's syndrome);
   5. Blood creatinine (Cre) ≤1.5×ULN, or calculated creatinine clearance (Ccr) ≥50 mL/min (using the Cockcroft-Gault formula);
   6. Cardiac function: Good hemodynamic stability, Left Ventricular Ejection Fraction (LVEF) ≥50%;
6. Eastern Cooperative Oncology Group (ECOG) performance status score: 0-2;
7. Expected survival >3 months;
8. 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 Criteria:

1. B-NHL participants with a history of Richter's transformation of chronic lymphocytic leukemia (CLL).
2. Primary central nervous system (CNS) lymphoma, or malignant tumors involving the CNS.
3. Burkitt's lymphoma/leukemia, primary mediastinal large B-cell lymphoma (LBCL).
4. 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.);
5. Active hepatitis B virus (HBV) infection;
6. Active hepatitis C virus (HCV) infection;
7. Active human immunodeficiency virus (HIV) infection or a past history of HIV infection;
8. Uncontrolled active infection requiring intravenous treatment within one week prior to the first dose;
9. Corrected QT interval using Fridericia (QTcF) is ≥450 ms (male) or ≥470 ms (female) according to the electrocardiography (ECG) examination results at screening;

10. Currently experiencing or having experienced within the past 6 months any of the following:

    1. Congestive heart failure (New York Heart Association [NYHA] Class III-IV);
    2. Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg with medication treatment;
    3. 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;
    4. Cerebrovascular accident, transient ischaemic attack;
    5. Symptomatic pulmonary embolism;
11. 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;
12. Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Experimental group; 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; Each participant receives MTM-H-001 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Dose-Limiting Toxicity (DLT)	Percentage of participants experiencing DLTs	42 days following first dose of MTM-H-001 for each participant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Percentage of participants who achieve complete response (CR) and partial response (PR) (evaluated by the investigator according to the criteria of Lugano 2014 and iWCLL 2018).	Throughout the study, up to 24 months
Disease control rate (DCR)	Percentage of participants who achieve complete response (CR), partial response (PR) and stable disease (SD).	Throughout the study, up to 24 months
Time to response (TTR)	Time from the first dose of MTM-H-001 to the first documented response (CR or PR).	Throughout the study, up to 24 months
Duration of response (DOR)	Time from the first documented objective response (CR or PR) to the first documented progressive disease (PD) or death from any cause (whichever occurs first).	Throughout the study, up to 24 months
Event-free survival (EFS)	Time from the first dose of MTM-H-001 to the first documented PD or relapse, initiation of any new anti-lymphoma treatment, or death from any cause (whichever occurs first).	Throughout the study, up to 24 months
Progression free survival (PFS)	Time from the first dose of MTM-H-001 to the first documented PD or death from any cause (whichever occurs first).	Throughout the study, up to 24 months
Overall survival (OS)	Time from the first dose of MTM-H-001 to death from any cause.	Throughout the study, up to 24 months

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: MagicTime Medicine
• Investigators: Principal Investigator: Ning Li, Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: March 12, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Chronic Disease; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Leukemia, B-Cell; Lymphoma, B-Cell; Leukemia, Lymphoid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone
• Other Study ID Numbers: MTM-H-001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No