Systemic Lupus Erthematosus (SLE)ArchAid-002NCT07593911
A Study to Evaluate MTM-H-001 Injection in Adult Patients With B-Cell-Related Autoimmune Diseases
A study testing MTM-H-001 Injection in people with Systemic Lupus Erthematosus (SLE) and Lupus Nephritis (LN), run by Beijing GoBroad Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Multiple Sclerosis
- What is being tested?
- MTM-H-001 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- Jun 2026to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Yusha Huang contact
China1 site
Beijing GoBroad Hospital
Beijing, Beijing Municipality, 102206
Jing Pan, Ph.D, +86-010-50847588 ext. 869, panj@gobroadhealthcare.com
Jing Pan, Ph.D
About this study
Official title: 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.
- Conditions
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Multiple Sclerosis, Myasthenia Gravis (MG), IgG4-Related Diseases, Rheumatoid Arthritis (RA)
- Being tested
- MTM-H-001 Injection
- Medical subject headings
- Lupus Nephritis, Multiple Sclerosis, Myasthenia Gravis, Immunoglobulin G4-Related Disease, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MTM-H-001 InjectionDrug
Each participant receives MTM-H-001 Injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: MTM-H-001 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicity (DLT)
Percentage of participants experiencing DLTs
Measured: 42 days following first dose of MTM-H-001 for each participant
Secondary outcomes (3)
Change from baseline in disease activity
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
Measured: Throughout the study, up to 12 months for each participant
Change from baseline in Physician Global Assessment (PhGA)
Change of Physician Global Assessment (PhGA) score from baseline
Measured: Throughout the study, up to 12 months for each participant
Change from baseline in health-related quality of life (HRQoL) score
Change from baseline in health-related quality of life (HRQoL) score
Measured: Throughout the study, up to 12 months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study startJun 2026 (estimated)
- Primary completionNov 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erthematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing GoBroad Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MagicTime Medicine
- Responsible party
- Sponsor
- Investigators
- Jing Pan, Ph.D, Principal investigator, Beijing GoBroad Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07593911
- Sponsor's protocol ID
- MTM-H-001-003
- Acronym
- ArchAid-002
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07593911
- Acronym / sponsor ID
- ArchAid-002 / MTM-H-001-003
- Conditions
- Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN), Multiple Sclerosis, Myasthenia Gravis (MG), IgG4-Related Diseases, Rheumatoid Arthritis (RA)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Beijing GoBroad HospitalUniversity, hospital or other
- Collaborators
- MagicTime Medicine
- Study start
- Jun 2026 (estimated)
- Primary completion
- Nov 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: MTM-H-001 InjectionPart 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MTM-H-001 InjectionEach participant receives MTM-H-001 Injection | Drug | Experimental group |
Primary outcome
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
3 secondary outcomes
Change from baseline in disease activity
Time frame: 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 from baseline in health-related quality of life (HRQoL) score
Time frame: Throughout the study, up to 12 months for each participant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yusha Huang contact
Jing Pan, Ph.D principal investigator
Beijing GoBroad Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MTM-H-001 Injection in people with Systemic Lupus Erthematosus (SLE) and Lupus Nephritis (LN), run by Beijing GoBroad Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Pan, Ph.D (+86-010-50847588 ext. 869, panj@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicity (DLT) (time frame: 42 days following first dose of MTM-H-001 for each participant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.