A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases

NCT07593911 | Not Yet Recruiting

• 1 other identifier: MTM-H-001-003
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 B-cell-related autoimmune diseases.

Conditions

Systemic Lupus Erthematosus (SLE); Lupus Nephritis (LN); Multiple Sclerosis; IgG4-Related Diseases; Rheumatoid Arthritis (RA); Myasthenia Gravis (MG)

Outcome Measures

Primary Outcomes (1)

• Incidence of Dose-Limiting Toxicity (DLT)

  Percentage of participants experiencing DLTs

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

Secondary Outcomes (3)

• Change from baseline in disease activity

  Throughout the study, up to 12 months for each participant

• Change from baseline in Physician Global Assessment (PhGA)

  Throughout the study, up to 12 months for each participant

• Change from baseline in health-related quality of life (HRQoL) score

  Throughout the study, up to 12 months for each participant

Study Arms (1)

Experimental group

EXPERIMENTAL

Part A: Dose Escalation Part, MTM-H-001 Injection, 5 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, 6 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

Interventions

MTM-H-001 Injection DRUG

Each participant receives MTM-H-001 Injection

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Confirmed diagnosis of the target autoimmune disease per international classification criteria;
• Adequate organ function to tolerate treatment;
• 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.

You may not qualify if:

• Active, severe, uncontrolled infection;
• Pregnancy or breastfeeding women;
• History of malignancy within the protocol-defined period, except adequately treated low-risk cancers;
• Any condition that, in the investigator's opinion, would compromise safety, compliance, or interpretability of study data.

Sponsors & Collaborators

• Beijing GoBroad Hospital: lead
• MagicTime Medicine: collaborator

Study Sites (1)

Beijing GoBroad Hospital

Beijing, Beijing Municipality, 102206, China

Location

MeSH Terms

Conditions

Lupus Nephritis; Multiple Sclerosis; Myasthenia Gravis; Immunoglobulin G4-Related Disease; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jing Pan, Ph.D

  Beijing GoBroad Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Pan, Ph.D

CONTACT

+86-010-50847588; panj@gobroadhealthcare.com

Yusha Huang

CONTACT

yushahuang@MagicTimeMed.onmicrosoft.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)