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Relapsed/Refractory Multiple MyelomaPhase 1/2NCT04309981

Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody.

A Phase 1/2 study testing Adult differentiated autologous T-cells with anti-BCMA specificity in people with Relapsed/Refractory Multiple Myeloma, run by Sara V. Latorre at 7 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 The sponsor has not verified this record for over two years, so it may be out of date.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 safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Adult differentiated autologous T-cells with anti-BCMA specificity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
7 sitesSpain
Study dates
27 May 2020to 1 Apr 2025
Phase
Phase 1/2
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between the age of 18 and 75 years with diagnosis of multiple myeloma
  • Disease measurable by monoclonal component in serum and/or urine or by free light chains in serum according to the eligibility criteria for clinical trials of the International Myeloma Working Group
  • Previous two or more lines of treatment. Patients must have received at least a proteasome inhibitor (such as bortezomib or carfilzomib), an immunomodulatory drug (lenalidomide or pomalidomide) and an anti-CD38 monoclonal antibody (such as daratumumab)
  • Refractory to the last line of treatment
  • ECOG functional status ranging from 0 to 2
  • Life expectancy over 3 months
  • Patients who, after being informed, give their consent by signing the Informed Consent document.

Who cannot join

  • Previous allogeneic transplant in the prior 6 months to inclusion or GVHD that requires active systemic immunosuppressive treatment
  • Absolute lymphocyte count <0.1x10^9/ L
  • Previous neoplasia, except if patients have been in complete remission > 3 years, except for cutaneous carcinoma (non-melanoma)
  • Active infection that requires treatment
  • Active infection by HIV, HBV or HCV.
  • Uncontrolled medical disease
Show all 12Show fewer
  • Severe organic condition that meets any of the following criteria: EF <40%, DLCO <40%, EGFR <50 ml / min, bilirubin> 3 times normal value (except Gilbert syndrome)
  • Previous diagnosis of symptomatic AL amyloidosis
  • Pregnant or lactating women. Women of childbearing age should have a negative pregnancy test in the screening phase
  • Women of childbearing age, including those whose last menstrual cycle was in the year prior to screening, who cannot or do not wish to use highly effective contraceptive methods from the beginning until the end of the study.
  • Men who cannot or do not wish to use highly effective contraceptive methods from the beginning to the end of the study.
  • Contraindication to receive conditioning chemotherapy

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Spain7 sites

  • Hospital Clinic of Barcelona

    Barcelona, 08036

  • Hospital 12 de Octubre

    Madrid, 28041

  • Hospital Clínico Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario de Salamanca

    Salamanca, 37007

  • Hospital U. de Santiago de Compostela

    Santiago de Compostela, A Coruña, 15706

  • Hospital Universitario Virgen Del Rocío

    Seville, 41013

Other trials in Spain

About this study

Official title: Pilot 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-BCMA (TNFRSF17) Specificity Humanized Conjugated With the Co-stimulatory Region 4-1BB and Signal-transduction CD3z (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma With Previous Treatment With Proteasome Inhibitor, Immunomodulatory Drug and Anti-CD38 Monoclonal Antibody

To assess the safety and efficacy of CARTBCMA ARI0002h in patients with relapsed/refractory multiple myeloma who have received treatment with proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.

Being tested
Adult differentiated autologous T-cells with anti-BCMA specificity
Medical subject headings
Multiple Myeloma

What participants receive

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

  • Adult differentiated autologous T-cells with anti-BCMA specificityBiological

    Also called CARTBCMA

    After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused.

Study groups in NCT04309981
Study groupRoleWhat they receive
ARI0002hExperimentalAdult differentiated autologous T-cells from peripheral blood, expanded and transducted with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory region and signal-transduction CD3z that has been humanized
Receives: Biological: Adult differentiated autologous T-cells with anti-BCMA specificity

What is being measured

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

  1. Overall response rate (ORR)

    Measured: 3 months

  2. Cytokine release syndrome rate

    Measured: within 30 days of first infusion

Secondary outcomes (17)

  1. Duration of the response

    Measured: up to 36 months after treatment

  2. Response rate

    Measured: over the first year

  3. Complete response rate (CR)

    Measured: at month 3 and month 6 of first infusion

  4. Overall response rate (ORR)

    Measured: at month 6 of first infusion

  5. Time to complete response

    Measured: up to 36 months after treatment

  6. Response rate of extramedullary disease by PET-CT

    Measured: up to 36 months after treatment

  7. Negative MRD rate in bone marrow

    Measured: at month 3 and month 6 of first infusion

  8. Response rate of extramedullary disease by PET-TC

    Measured: at month 3

  9. Progression free survival (PFS)

    Measured: at month 12, and up to 36 months after treatment

  10. Overall survival (OS) defined as the time elapsed between the infusion of ARI0002h and the death of the patient from any cause

    Measured: up to 36 months after treatment

  11. Presence of tumor lysis syndrome

    Measured: up to 36 months after treatment

  12. Presence of cytokine release syndrome

    Measured: up to 36 months after treatment

  13. Presence of neurological toxicity

    Measured: up to 36 months after treatment

  14. Presence of prolonged cytopenia

    Measured: up to 36 months after treatment

  15. Persistence of CART BCMA ARI0002 in peripheral blood

    Measured: month 1, 2, 3, 4, 5, 6 and every 6 months until 2 years of follow up

  16. Expression of BCMA

    Measured: at screening, at day +28, at day +100, at month 6, 12, 18 and 24

  17. Levels of soluble BCMA in serum

    Measured: at screening, at day 0, +3, +7,+14,+28, +70 +100, at month 4, 5, 6, 7, 8, 9, 1,11, 12, 18 and 24

Timeline

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

  1. First posted17 Mar 2020
  2. Study start27 May 2020
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04309981
Sponsor's protocol ID
CARTBCMA-HCB-01
Other IDs
2019-001472-11, 2019
Status last verified
Jul 2023
First submitted
9 Mar 2020
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zugasti I, Tormo-Ratera M, Oliver-Caldes A, Soler-Perromat JC, Gonzalez-Calle V, Moreno DF, Cabanas V, Lopez-Munoz N, Bartolome-Solanas A, Espanol-Rego M, Reguera-Ortega JL, Rosinol L, Lopez-Corral L, Tovar N, Rodriguez-Lobato LG, Alvarez Perez RM, Varea S, Olesti E, Gomez-Grande A, Frutos L, Tamayo P, Juan M, Moraleda JM, Urbano-Ispizua A, Gonzalez-Navarro EA, Martinez-Lopez J, Mateos MV, Tomas X, Setoain X, Fernandez de Larrea C. Clinical impact of [18F]FDG-PET/CT in ARI0002h treatment, a CAR-T against BCMA for relapsed/refractory multiple myeloma. Blood Adv. 2025 Feb 11;9(3):571-582. doi: 10.1182/bloodadvances.2024014360.

    PubMed 39602341

  • Oliver-Caldes A, Gonzalez-Calle V, Cabanas V, Espanol-Rego M, Rodriguez-Otero P, Reguera JL, Lopez-Corral L, Martin-Antonio B, Zabaleta A, Inoges S, Varea S, Rosinol L, Lopez-Diaz de Cerio A, Tovar N, Jimenez R, Lopez-Parra M, Rodriguez-Lobato LG, Sanchez-Salinas A, Olesti E, Calvo-Orteu M, Delgado J, Perez-Simon JA, Paiva B, Prosper F, Saez-Penataro J, Juan M, Moraleda JM, Mateos MV, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. Fractionated initial infusion and booster dose of ARI0002h, a humanised, BCMA-directed CAR T-cell therapy, for patients with relapsed or refractory multiple myeloma (CARTBCMA-HCB-01): a single-arm, multicentre, academic pilot study. Lancet Oncol. 2023 Aug;24(8):913-924. doi: 10.1016/S1470-2045(23)00222-X. Epub 2023 Jul 3.

    PubMed 37414060

  • Oliver-Caldes A, Jimenez R, Espanol-Rego M, Cibeira MT, Ortiz-Maldonado V, Quintana LF, Castillo P, Guijarro F, Tovar N, Montoro M, Benitez-Ribas D, Bataller A, Gonzalez-Navarro EA, Cid J, Lozano M, Perez-Amill L, Martin-Antonio B, Mena MP, Moreno DF, Rodriguez-Lobato LG, Campistol JM, Calvo G, Blade J, Rosinol L, Juan M, Pascal M, Urbano-Ispizua A, Fernandez de Larrea C. First report of CART treatment in AL amyloidosis and relapsed/refractory multiple myeloma. J Immunother Cancer. 2021 Dec;9(12):e003783. doi: 10.1136/jitc-2021-003783.

    PubMed 34876408

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Adult differentiated autologous T-cells with anti-BCMA specificity in people with Relapsed/Refractory Multiple Myeloma, run by Sara V. Latorre 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 7 inclusion and 12 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 28 Aug 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Overall response rate (ORR) (time frame: 3 months). 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 NCT04309981, which also lists 3 linked publications.

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 28 Aug 2023.

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