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Acute Lymphoid LeukemiaPhase 2CART19-BE-02NCT04778579

Study of the Infusion of ARI-0001 Cells in Patients With CD19 + Acute Lymphoid Leukemia Resistant or Refractory to Therapy

A Phase 2 study testing ARI-0001 cells in people with Acute Lymphoid Leukemia, run by Sara V. Latorre at 9 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To assess the efficacy (in terms of response rate and duration) of the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated to the 4-aBB and CD3z… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Lymphoid Leukemia
What is being tested?
ARI-0001 cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
9 sitesSpain
Study dates
11 May 2021to 31 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnoses of CD19+ acute lymphoid leukemia, with a life expectancy of less than 2 years that meet the following conditions:
  • Relapsed/refractory not candidate for transplantation (due to associated diseases or absence of donor)
  • in allogenic post-transplant relapse.
  • Measurable disease understood as the presence of measurable residual disease by flow cytometry in bone marrow or peripheral blood
  • Age less than 70 years (from 18 to 70).
  • ECOG functional status from 0 to 2
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  • Life expectancy of at least 3 months.
  • Adequate venous access to perform a lymphapheresis. Absence of contraindications for it.
  • Signature of informed consent.

Who cannot join

  • Treatment with any experimental or non-marketed substance within four weeks prior to recruitment, or actively participating in another therapeutic trial.
  • Previous treatment with CART therapy (commercial or experimental)
  • Diagnosis of another neoplasm, past or present. Patients may be included in complete remission for more than 3 years, or have a history of non-melanoma skin cancer or in-situ carcinoma resected completely.
  • Relief of central nervous system (CNS-3) at the time of inclusion. Inclusion will be permitted in patients with a lower grade (CNS-2) or CNS-3 who have responded to intrathecal chemotherapy.
  • Isolated extramedullary involvement (i.e. in the absence of minimal residual disease in peripheral blood, bone marrow, or cerebrospinal fluid)
  • Early relapse after transplantation (less than 3 months for mononuclear cell apheresis, less than 6 months for infusion of ARI-0001)
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  • Active immunosuppressive treatment for graft-versus-host disease and other diseases. The use of corticosteroids to control leukaemia at the time of inclusion should be limited as much as possible and should be discontinued prior to infusion of ARI-0001 cells.
  • Active infection requiring systemic medical treatment such as chronic kidney infection, chronic lung infection or tuberculosis.
  • HIV infection.
  • Positive serology for hepatitis B, defined as a positive test for HBsAg. In addition, if the patient is HBsAg negative but has anti-HBc antibodies it will be necessary to perform a DNA test of the hepatitis B virus, and if the result is positive the patient will be excluded
  • Positive serology for hepatitis C, defined as a positive test for anti-VHC antibodies confirmed by RIBA
  • Concurrent uncontrolled medical illnesses including cardiac, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological or psychiatric diseases that in the opinion of the investigator are potential risk factors to the patient.
  • Severe organ involvement, defined as cardiac ejection fraction <40%; DLCO <40%; calculated glomerular filtrate <30 ml/min; or bilirubin > 3 times the upper limit of normality (unless Gilbert syndrome).
  • Pregnant or lactating women. Woman of childbearing potential should have a negative pregnancy test in the screening phase.
  • Women of childbearing potential, including those whose last menstrual cycle was in the year prior to screening, who are unable or unwilling to use highly effective contraceptive methods* from the start of the study to the completion of the study.
  • Men who cannot or do not wish to use highly effective contraceptive methods* from the beginning of the study until the end of the study
  • -

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

Spain9 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Clinic of Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Clínico Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital U. Virgen del Rocío

    Seville, 41013

Other trials in Spain

About this study

Official title: Phase 2 Study of the Infusion of Differentiated Autologous T-cells From Peripheral Blood, Expanded and Transduced With a Lentivirus to Express a Chimeric Antigen Receptor With Anti-CD19 Specificity (A3B1) Conjugated With the Co-stimulatory Regions 4-1BB and CD3z (ARI-0001 Cells) in Patients With CD19+ Acute Lymphoid Leukemia Resistant or Refractory to Therapy

To assess the efficacy (in terms of response rate and duration) of the infusion of ARI-0001 cells (Adult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity [A3B1] conjugated to the 4-aBB and CD3z co-stimulatory regions) in patients with resistant or refractory CD19+ acute lymphoid leukemia

Being tested
ARI-0001 cells
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

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

  • ARI-0001 cellsDrug

    Also called CART19, PEI 19-187

    Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z

Study groups in NCT04778579
Study groupRoleWhat they receive
ARI-0001ExperimentalAfter pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.
Receives: Drug: ARI-0001 cells

What is being measured

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

  1. Response rate

    • Response rate with measurable residual disease negative by multiparametric flow cytometry

    Measured: 20 days after infusion

Timeline

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

  1. First posted3 Mar 2021
  2. Study start11 May 2021
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04778579
Sponsor's protocol ID
CART19-BE-02
Acronym
CART19-BE-02
Status last verified
Jun 2024
First submitted
26 Feb 2021
Last updated
26 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ortiz-Maldonado V, Martinez-Cibrian N, Alserawan L, Espanol-Rego M, Navarro-Velazquez S, Albiol N, Oliver-Caldes A, Triguero A, Herrero-Garcia M, Gutierrez-Herrero S, Benitez-Ribas D, Paciello ML, Torrent A, Delgado-Serrano J, Sanchez-Castanon M, Calderon H, Mata JJ, Sanchez-Salinas A, Saez-Penataro J, Sans-Pola C, Calvo-Orteu M, Lopez-Corral L, Kwon M, Rifon J, Charry P, Alonso-Fernandez RA, Huguet M, Blazquez-Goni C, Sanchez-Pina JM, Sanchez R, Rosa-Rosa JM, Martinez-Lopez J, Blanquer M, Ribera JM, Urbano-Ispizua A, Bachiller M, Palau L, Olesti E, Calvo G, Martin-Martin L, Orfao A, Gonzalez-Navarro EA, Domenech G, Varea S, Juan M, Delgado J, Esteve J. Varnimcabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in Spain (CART19-BE-02): a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2026 Mar;13(3):e133-e143. doi: 10.1016/S2352-3026(25)00328-X. Epub 2026 Feb 3.

    PubMed 41651004

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARI-0001 cells in people with Acute Lymphoid Leukemia, run by Sara V. Latorre at 9 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 9 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: 20 days after infusion). 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 NCT04778579, 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 Jun 2024.

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