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Lymphoma, Large B-Cell, Diffuse (DLBCL)Archonc-001NCT07476378

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

A study testing MTM-H-001 Injection in people with Lymphoma, Large B-Cell, Diffuse (DLBCL) and Lymphoma, Follicular, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
MTM-H-001 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteChina
Study dates
Mar 2026to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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;
  • 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;
  • Pregnant or breastfeeding women.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michael Green contact

716-474-6710

michaelgreen@magictimemed.com

China1 site

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Langfang, Hebei, 065000

    Ning Li, Ph.D, +86-010-87788713, Lining@cicams.ac.cn

    Yale Jiang, +86-13261010586, yalejiang@cicams.ac.cn

Other trials in China

About this study

Official title: 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.

Being tested
MTM-H-001 Injection
Medical subject headings
Lymphoma, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MTM-H-001 InjectionDrug

    Each participant receives MTM-H-001 Injection

Study groups in NCT07476378
Study groupRoleWhat they receive
Experimental groupExperimentalPart 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
Receives: Drug: MTM-H-001 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Dose-Limiting Toxicity (DLT)

    Percentage of participants experiencing DLTs

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

Secondary outcomes (7)

  1. 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).

    Measured: Throughout the study, up to 24 months

  2. Disease control rate (DCR)

    Percentage of participants who achieve complete response (CR), partial response (PR) and stable disease (SD).

    Measured: Throughout the study, up to 24 months

  3. Time to response (TTR)

    Time from the first dose of MTM-H-001 to the first documented response (CR or PR).

    Measured: Throughout the study, up to 24 months

  4. 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).

    Measured: Throughout the study, up to 24 months

  5. 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).

    Measured: Throughout the study, up to 24 months

  6. 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).

    Measured: Throughout the study, up to 24 months

  7. Overall survival (OS)

    Time from the first dose of MTM-H-001 to death from any cause.

    Measured: Throughout the study, up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
69 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07476378
Sponsor's protocol ID
MTM-H-001-001
Acronym
Archonc-001
Status last verified
Mar 2026
First submitted
12 Mar 2026
Last updated
17 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MTM-H-001 Injection in people with Lymphoma, Large B-Cell, Diffuse (DLBCL) and Lymphoma, Follicular, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michael Green (716-474-6710, michaelgreen@magictimemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose-Limiting Toxicity (DLT) (time frame: 42 days following first dose of MTM-H-001 for each participant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07476378.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.

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