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New drug MTM-H-001 takes on tough blood cancers

NCT ID NCT07476378

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests a new drug called MTM-H-001 in 69 adults with B-cell blood cancers (like certain lymphomas and leukemias) that have come back or stopped responding to treatment. The main goal is to check safety and find the right dose, while also seeing if it can shrink tumors. It's an open-label, single-arm trial, meaning everyone gets the drug and there's no placebo group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MTM-H-001 Injection
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-treat B-cell blood cancers.
What could go wrong
This is a very early, small trial (69 people) with no control group. It mainly checks safety, so it may not show clear benefit or could have unexpected side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 69 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Langfang, Hebei, 065000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.