Study QEL-005-CLN-01. Phase I/II study of QEL-005 in patients with diffuse cutaneous systemic sclerosis (dcSSc) and in patients with difficult to treat rheumatoid arthritis (D2TRA).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Quell Therapeutics Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2026-04-21

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Quell Therapeutics Limited

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy, Therapy, Dose response

To determine the safety and tolerability of a single dose of QEL-005.

Secondary objectives 2

1. To understand early signs of clinical activity of QEL-005 in participants with D2TRA.
2. To understand early signs of clinical activity of QEL-005 in participants with dcSSc.

Conditions and MedDRA coding

Diffuse cutaneous systemic sclerosis (dcSSc) Difficult to treat rheumatoid arthritis (D2TRA)

Regulatory references

Scientific advice from competent authorities

Paul-Ehrlich-Institut, Medicines And Healthcare Products Regulatory Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Participants must be at least 18 years of age at the time of signing the informed consent.
2. Up to date vaccination schedule as per local guidance
3. Adequate haematological, liver and renal function as assessed by the Investigator according to local laboratory tests
4. Willing to undergo annual influenza vaccination
5. Willing to enter a 15-year follow-up
6. Eastern Cooperative Oncology Group (ECOG) performance status grade < 3
7. Able and willing to use a highly effective method of contraception
8. Stable dose of steroid prior to screening
9. Specific inclusion criteria for participants with difficult to treat rheumatoid arthritis (D2TRA) only: 1. Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria 2. Diagnosis of D2TRA per 2021 EULAR criteria 3. Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA. 4. Evidence of inflammation in target joints used for the DAS28 CRP assessment
10. Specific inclusion criteria for participants with systemic sclerosis (SSc) only 1. Diagnosis of diffuse cutaneous systemic sclerosis (dcSSc) as per the 2013 ACR-EULAR criteria. 2. Serologically positive for antinuclear antibodies 3. Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs). 4. Skin involvement with a total modified Rodnan Skin Score of at least 15 Evidence of lung fibrosis based on imaging or pulmonary function testing 5. Evidence of active disease based on a validated SSc activity assessment

Exclusion criteria 8

1. Presence of a significant medical condition(s), or clinically significant laboratory abnormality, that, in the Investigator's opinion, may impact participant safety or the participant’s ability to undergo study procedures.
2. History or concern of autoimmune diseases other than those under study
3. Active infection, or recurrent chronic infection requiring intervention
4. Immunodeficiency or receiving immunoglobulin replacement therapy
5. Past or current infection with Hepatitis B or C, tuberculosis (TB), syphilis or HIV.
6. Participants with clinically significant cardiac dysfunction or pulmonary disease
7. History of malignancy within the past 5 years
8. Receiving prohibited medications that cannot be stopped at screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Dose escalation part: Incidence of protocol-defined dose-limiting toxicities (DLTs) within 14 days postinfusion; Treatment-emergent SAEs, adverse events (AEs) and AEs of Special Interest (AESIs); Clinically significant changes in safety laboratory assessments, ECG and vital signs.
2. Expansion part: Treatment-emergent serious adverse events (SAEs), adverse events (AEs) and AEs of Special Interest (AESIs); Clinically significant changes in safety laboratory assessments, electrocardiogram (ECG) and vital signs.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Quell Therapeutics Limited

Sponsor organisation

Quell Therapeutics Limited

Address

3rd Floor, Translation And Innovation Hub, 84 Wood Lane Translation And Innovation Hub 84 Wood Lane

City

London

Postcode

W12 0BZ

Country

United Kingdom

Scientific contact point

Organisation

Quell Therapeutics Limited

Contact name

Clinical Department

Public contact point

Organisation

Quell Therapeutics Limited

Contact name

Clinical Department

Third parties 8

Locations

2 EU/EEA countries · 4 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 31 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications