A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)

May 12, 2026 updated by: Beijing GoBroad Hospital

An Open-Label, Single-Arm, Dose-Escalation and Expansion Basket Study Evaluating the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Efficacy of MTM-H-001 in Patients With B-Cell-Related Autoimmune Diseases (ArchAid-002)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 102206
        • Beijing GoBroad Hospital
        • Contact:
        • Principal Investigator:
          • Jing Pan, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Key inclusion criteria include：

    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. Confirmed diagnosis of the target autoimmune disease per international classification criteria;
    4. Adequate organ function to tolerate treatment;
    5. 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:

  • Key exclusion criteria include:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group

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
Each participant receives MTM-H-001 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Dose-Limiting Toxicity (DLT)
Time Frame: 42 days following first dose of MTM-H-001 for each participant
Percentage of participants experiencing DLTs
42 days following first dose of MTM-H-001 for each participant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in disease activity
Time Frame: Throughout the study, up to 12 months for each participant
Change from baseline in autoimmune disease activity, e.g. Change from baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score for SLE
Throughout the study, up to 12 months for each participant
Change from baseline in Physician Global Assessment (PhGA)
Time Frame: Throughout the study, up to 12 months for each participant
Change of Physician Global Assessment (PhGA) score from baseline
Throughout the study, up to 12 months for each participant
Change from baseline in health-related quality of life (HRQoL) score
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing GoBroad Hospital

Collaborators

MagicTime Medicine

Investigators

  • Principal Investigator: Jing Pan, Ph.D, Beijing GoBroad Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTM-H-001-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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