Dendritic cell therapy combined treatment in multiple sclerosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

13 Jan 2025 → 3 Mar 2026

Decision date (initial)

2025-01-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519975-24-00

EudraCT number

2020-000737-41

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To evaluate the radiological efficacy and safety of TolDec therapy in combination with first line immunotherapy in RRMS patients.

Secondary objectives 8

1. To evaluate the safety and tolerability of the TolDec therapy in combination with first line immunotherapy in RRMS patients.
2. To evaluate the clinical efficacy of the TolDec therapy in combination with first line immunotherapy in terms of (1) relapse rate and (2) disability scales (EDSS and MSFC) in RRMS patients at week 24 and 48.
3. To evaluate the radiological efficacy of the TolDec therapy in combination with first line immunotherapy by the presence of CUA lesions through 24 week period.
4. To evaluate the radiological efficacy of the TolDec therapy in combination with first line immunotherapy by the presence of gadolinium enhancing, new or enlarging T2 lesions, and cortical lesions through 24 week period.
5. To evaluate changes in brain volume (global, white and gray matter) and cervical cord at different time points during the study period.
6. Changes from baseline in the number of cortical lesions on MRI at 24 weeks.
7. To evaluate the advanced MR measurements of diffuse damage of brain tissue by magnetization transfer image (MTR) and relaxation times of T1 and T2, and Diffusion tensor imaging (DWI) at week 12 and 24.
8. To evaluate immunological changes by cytokine production, T-cell Ag specific proliferation, and peripheral T-cell subsets.

Conditions and MedDRA coding

Multiple sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age between 18-65 years old.
2. Patients diagnosed with RRMS according to 2017 McDonald criteria (see Appendix 1).
3. MS disease duration < 10 years.
4. Expanded disability status scale (EDSS) from 0 to < 5.5.
5. Patients eligible to start or already are in on treatment with first line immunomodulatory treatment (interferon beta 1a, interferon beta 1b, glatiramer acetate, teriflunomide or dymethyl-fumarate).
6. One or more documented relapses within the 2 years before the screening with either: a) one relapse which occurred within the last year prior the screening of the study; b) the presence of ≥ 1Gd+ T1 lesion or ≥ 2 new T2 lesion within 12 months prior the screening of the study (i.e, compared with an cerebral MRI in the last 12 months).
7. Able to sign informed consent.
8. Women of child-bearing potential* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogenonly hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence.

Exclusion criteria 15

1. Presence of a relapse or use of steroids 30 days prior to screening visit.
2. Concomitant use of any type of immunomodulatory / immunosuppressive therapy.
3. Use of previous immunosuppressive or cytotoxic therapy in the last 6 months. Use of previous alemtuzumab, cladribine or bone marrow or stem cell transplant at any time.
4. Patients unable or unwilling to undergo MRI scans.
5. Severe systemic diseases or history of cancer or hereditary familiar cancer.
6. Clinically relevant concomitant disease: cardiac, gastrointestinal, hepatic, pulmonary, neurological, renal or other major disease.
7. Impossibility to proceed to the leukapheresis (e.g. absence of peripheral venous access).
8. Pregnant or breastfeeding women.
9. Drug or alcohol abuse.
10. Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at screening.
11. Ongoing known bacterial, viral or fungal infection (with the exception of onychomycosis and dermatomycosis), positive hepatitis B surface antigen or hepatitis C antibody tests at screening.
12. Patients with a known history of syphilis or tuberculosis or test positive for syphilis (positive rapid plasma reagin, RPR) or tuberculosis (positive skin test) at screening. Active or latent tuberculosis (TB).
13. Dementia or severe psychiatric, cognitive or behavioral problems or other comorbidity that may interfere with the compliance to the protocol.
14. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the subject at risk by participating in the study.
15. Participation in other experimental studies within the previous 90 days prior to screening visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. EFFICACY - Changes from baseline in the number of CUA lesion (mean number of the sum at week 12, 18 and 24). A CUA lesion is defined as a new or persisting gadolinium-enhancing (Gd+) lesion on T1 MRI or a new or enlarging lesion on T2. Lesions identified in both scans were only counted once.
2. SAFETY: - Proportion of patients with any Grade 3 -4 adverse events related to product administration during the study period. - Proportion of patients with any Grade 3 -4 adverse events related to study product.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Sponsor organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Address

Calle Rosellon 149-153

City

Barcelona

Postcode

08036

Country

Spain

Scientific contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Dra. Yolanda Blanco

Public contact point

Organisation

Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer

Contact name

Dra. Yolanda Blanco

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 4 files

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

Application history

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