AzTrials
AzTrials

Refractory Non-Hodgkin LymphomaEarly Phase 1CARTD-BG-1NCT06097455

First in Human Study of the Infusion of ARI0003 Cells in Relapsed/Refractory to Treatment B-cell Aggressive Lymphoma

A Early Phase 1 study testing ARI0003 in people with Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by Fundacion Clinic per a la Recerca Biomédica at 7 sites in Spain.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or refractory (that means that they did not respond to other treatments). This is a first in human study. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ARI0003
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
7 sitesSpain
Study dates
15 Jan 2024to 15 Jan 2027
Phase
Early Phase 1
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Diagnosis of CD19+ or CD269+ relapsed/refractory (R/R) aggressive B-cell lymphoma in one of the following circumstances:
  • Burkitt's lymphoma;
  • Histology not covered by approved CART19-cell products (plasmablastic lymphoma, primary effusion lymphoma, intravascular lymphoma, transformed lymphoma from marginal zone lymphoma or chronic lymphocytic leukaemia, primary cutaneous DLBCL, T-cell rich DLBCL, high-grade B-cell lymphoma, grey zone lymphoma or grade 3b follicular lymphoma); or
  • Aggressive B-cell lymphoma that is refractory or relapsing after treatment with CART19-cell therapy.
  • 2. Age older than 18 years. 3. ECOG performance status of 0-2. 4. Estimated life expectancy of at least 3 months. 5. Adequate venous access and absence of contraindications for lymphapheresis. 6. Signature of informed consent. 7. In patients who have received any anti-CD19 or anti-CD269 therapy (e.g. tisagenlecleucel, axicabtagene autoleucel, tafasitamab, loncastuximab, belantamab mafodotin, idecabtagene vicleucel, etc.), a centralised tumour sample confirming the expression of at least one of the antigens (either CD19 or CD269) will be needed at study inclusion

Who cannot join

  • 1. Any experimental or non-commercialized therapy in the previous 4 weeks. 2. Any other concomitant neoplasia, unless it has been in complete remission for 3 years or longer, except for non-melanoma skin cancer or completely resected in situ carcinoma.
  • 3. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).
  • 4. Active infection requiring systemic medical therapy. 5. Active HBV or HCV infection. 6. Positive serology for HIV. 7. Any concomitant and uncontrolled medical disease. 8. Severe organic impairment defined by cardiac ejection fraction <40%, DLCO <40%, GFR <30 ml/min or bilirubin >3 times the upper limit of normality (unless due to Gilbert's syndrome).
  • 9. Lactating or pregnant women. 10. Men or women of childbearing potential unable or unwilling to use highly efficient contraceptive measures from the beginning until the end of the study.
  • 11. CNS disease in the form of a macroscopic solid lesion in the encephalon or spinal cord (isolated meningeal disease is allowed

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Julio Delgado, MD PhD contact

+34932275400

jdelgado@clinic.cat

Sara Varea, MSc contact

+34932275400

svarea@clinic.cat

7 sites in 1 country

Spain7 sites

  • Hospital Clínic Barcelona

    Barcelona, 08036

    Julio Delgado, +34932275400, jdelgado@clinic.cat

  • H. Ramon y Cajal

    Madrid

    Javier Lopez Jiménez, MD

  • H.U. Virgen de la Arrixaca

    Murcia

    Jose M Moraleda, MD PhD

  • Hospital Central de Asturias

    Oviedo

    Jose M Garcia Gala, MD

  • Hospital Son Espases

    Palma de Mallorca

    Leyre Bento de Miguel, MD

  • H. Clínico de Salamanca

    Salamanca

    Fermín Sanchez-Guijo

  • CHU Santiago de Compostela

    Santiago de Compostela, A Coruña

    Adrián Mosquera Orgeira, MD

Other trials in Spain

About this study

Official title: First in Human, Pilot, Open-label, Prospective, Multicentre, Non-randomised Clinical Trial to Evaluate the Safety and Efficacy of ARI0003 (CART CD19/ CD269 Cells) in Patients With Relapsed/Refractory B-cell Aggressive Lymphoma

ths study consist in testing a CAR T therapy (ARI0003 cells (antiCD19 and antiBCMA) in patients suffering relapsed NHL (that means that symptoms of NHL reappeared ) or refractory (that means that they did not respond to other treatments). This is a first in human study.

Being tested
ARI0003
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ARI0003Genetic

    Also called Adult autologous differentiated T-cells from peripheral blood, expanded and co-transduced lentiviruses: one containing a chimeric antigen receptor anti-CD19 and another containing an anti-CD269 (BCMA)

    Treatment with ARI0003 cells

Study groups in NCT06097455
Study groupRoleWhat they receive
ARI0003ExperimentalARI0003 will be administered intravenously under a split regime. A total dose between 0.5 and 5 x106 cell/Kg will be administered in 3 administrations (fractions):
Receives: Genetic: ARI0003

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of > grade 3 CRS and/or ICANS

    Rate of patients who develop grade > 3 cytokine release syndrome (CRS) and/or grade > 3 immune cell associated neurotoxicity syndrome (ICANS) according to the criteria and grading defined in the international consensus document of the American Society for Transplantation and Cellular Therapy (ASTCT criteria). ASTCT score can be between 1 and 4 (being 1 the minimum value and 4 the maximum) and where higher score means worse outcome.

    Measured: in the first 30 days after ARI0003 administration

  2. ORR

    Overall response rate (ORR) according to Lugano criteria (best response within 3 months post ARI0003 infusion

    Measured: within 3 months post ARI0003 infusion

Secondary outcomes (6)

  1. Procedure-related mortality (PRM)

    Procedure-related mortality (PRM), defined as any death not directly cause by the lymphoma that is related with the procedure. For the estimation of PRM, disease relapse will be considered as a competing event

    Measured: through study completion, an average of 24 months

  2. Toxicity: incidence of AE

    Toxicity defined as the incidence of grade >3 adverse events (AEs) as per CTCAE version 5.0. The following AEs will be considered AEs of special interest (AESI): CRS, ICANS, macrophagic activation syndrome (MAS), tumour lysis syndrome (TLS), prolonged cytopenia (beyond 6 months), infections and second primary malignancies

    Measured: at 3 and 12 months

  3. Complete response rate

    Complete response rate

    Measured: at 3 months

  4. Duration of response,

    Duration of response, calculated from the time of first disease evaluation (3 months);

    Measured: from month 3 to study completion, an average of 24 months

  5. Progression-free survival

    Progression-free survival, calculated from ARI-0003 cell infusion

    Measured: through study completion, an average of 24 months

  6. Overall survival

    Overall survival, calculated from ARI-0003 cell infusion

    Measured: through study completion, an average of 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start15 Jan 2024 (estimated)
  3. Primary completion15 Apr 2025 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06097455
Sponsor's protocol ID
CARTD-BG-1
Other IDs
2023-5072-13-97-00
Acronym
CARTD-BG-1
Status last verified
Oct 2023
First submitted
9 Oct 2023
Last updated
26 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bachiller M, Barcelo-Genestar N, Rodriguez-Garcia A, Alserawan L, Dobano-Lopez C, Gimenez-Alejandre M, Castellsague J, Colell S, Otero-Mateo M, Antonana-Vildosola A, Espanol-Rego M, Ferruz N, Pascal M, Martin-Antonio B, Anguela XM, Fillat C, Olesti E, Calvo G, Juan M, Delgado J, Perez-Galan P, Urbano-Ispizua A, Guedan S. ARI0003: Co-transduced CD19/BCMA dual-targeting CAR-T cells for the treatment of non-Hodgkin lymphoma. Mol Ther. 2025 Jan 8;33(1):317-335. doi: 10.1016/j.ymthe.2024.11.028. Epub 2024 Nov 19.

    PubMed 39563035

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing ARI0003 in people with Refractory Non-Hodgkin Lymphoma and Relapsed Non-Hodgkin Lymphoma, run by Fundacion Clinic per a la Recerca Biomédica at 7 sites in Spain.

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 5 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Julio Delgado, MD PhD (+34932275400, jdelgado@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of > grade 3 CRS and/or ICANS (time frame: in the first 30 days after ARI0003 administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06097455, which also lists 1 linked publication.

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 26 Oct 2023.

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