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, Follicular Lymphoma, Mantle-Cell Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)Lymphoma, B-Cell, Marginal Zone Transformed 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

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

Treatments tested in this trial

MTM-H-001 Injection

Treatment groups

69 Participants

are divided into 1 treatment group

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

MagicTime Medicine

Collaborator

Source ClinicalTrials.gov