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

ConditionsLymphoma, Large B-Cell, Diffuse (DLBCL)Lymphoma, FollicularLymphoma, Mantle-CellChronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Lymphoma, B-Cell, Marginal ZoneTransformed Follicular Lymphoma (TFL)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.);

Trial design

Design model

Sequential

Treatments tested in this trial

  • MTM-H-001 Injection

    Drug

    Each participant receives MTM-H-001 Injection

Treatment groups

69 Participants
are divided into 1 treatment group
Group A: Experimental groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Dose-Limiting Toxicity (DLT)

Percentage of participants experiencing DLTs

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

Secondary outcomes

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).

Time frame
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).

Time frame
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).

Time frame
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).

Time frame
Throughout the study, up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

MagicTime Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: