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Leukemia, Plasma CellPhase 2GEM-PLASMACARNCT06830733

Study to Evaluate the Safety and Efficacy of ARI0002h, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia

A Phase 2 study testing ARI0002h in people with Leukemia, Plasma Cell, 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
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Trial summary

Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Leukemia, Plasma Cell
What is being tested?
ARI0002h
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
7 sitesSpain
Study dates
Apr 2025to Dec 2027
Phase
Phase 2
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients between 18 and 75 years old diagnosed with newly diagnosed primary plasma cell leukemia (the presence of 5% or more circulating plasma cells in peripheral blood smears in patients otherwise diagnosed with symptomatic multiple myeloma), according to International Myeloma Working Group (IMWG).
  • Disease measurable at diagnosis by monoclonal component in serum or urine, or by free light chains in serum according to the eligibility criteria for clinical trials of the "International Myeloma Working Group".
  • ECOG Performance Status from 0 to 2
  • Life expectancy greater than 3 months.
  • Adequate venous access and absence of contraindications for lymphoapheresis.
  • Patients who, after being informed, give their consent by signing the Informed Consent Document.
  • Up to two cycles of previous treatment for symptomatic control will be allowed before inclusion.

Who cannot join

  • No previous treatments, except for induction therapy for primary plasma cell leukemia.
  • Administration of any anti-BCMA therapy as part of induction
  • Not having achieved at least a minimal response with induction treatment (IMWG criteria)
  • Absolute lymphocyte count <0.1x109/L
  • Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).
  • 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.
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  • Active infection requiring treatment.
  • Active HIV, HBV, or HCV infection.
  • Uncontrolled medical illness
  • Severe organ impairment that meets any of the following criteria: EF<40%, DLCO <40%, GFR <30 ml/min, bilirubin >3 times the upper limit of normality (unless due to Gilbert syndrome)
  • Previous diagnosis of symptomatic AL amyloidosis,
  • Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at 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 beginning of the study to completion of the study.
  • Men who are unable or unwilling to use highly effective contraceptive methods* from the beginning of the study to completion of the study.
  • Contraindication to receive lymphodepletive chemotherapy.

Trial locations and contacts

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

Carlos Fernandez de Larrea, MD, PhD contact

+34932775400

cfernan1@clinic.cat

Maria Joyera contact

+34932775400

joyera@recerca.clinic.cat

7 sites in 1 country

Spain7 sites

  • Hospital Clinic Barcelona

    Barcelona, 08036

    Carlos Fernandez de Larrea, +34932275400, cfernan1@clinic.cat

  • Clínica Universitaria de Navarra

    Madrid, Madrid, 28027

    Paula Rodríguez Otero, 913 53 19 20, paurodriguez@unav.es

  • Hospital 12 de Octubre

    Madrid, Madrid, 28041

    Rafael Alonso, 913 90 80 00, rafaelalberto.alonso@salud.madrid.org

  • Hospital Universitario Virgen de la Arrixaca

    Murcia, Murcia, 30120

    Valentín Cabañas, 968 36 95 00, valentin.cabanas@gmail.com

  • Clínica Universitaria de Navarra

    Pamplona, Navarre, 31008

    Paula Rodríguez Otero, 948 25 54 00, paurodriguez@unav.es

  • Complejo Asistencial Universitario de Salamanca

    Salamanca, Salamanca, 37007

    María Victoria Mateos, 923 29 11 00, mvmateos@usal.es

  • Hospital Marqués de Valdecilla

    Santander, Cantabria, 39008

    María Aranzazu Bermúdez Rodriguez, 942 20 25 20, maranzazu.bermudez@scsalud.es

Other trials in Spain

About this study

Official title: Phase II, Multicenter, Open-label, Prospective, Non-randomized Study to Evaluate the Safety and Efficacy of ARI0002h, a CAR-T Cell Against BCMA, for the Initial Treatment of Patients With Primary Plasma Cell Leukaemia

Phase II, pilot, open-label, prospective, multicenter, non-randomized study to evaluate the safety and efficacy of ARI0002h (cesnicabtagene autoleucel) in 20 patients with newly diagnosed primary plasma cell leukemia (PCL).

The study population is patients between 18 and 75 years of age with newly diagnosed primary plasma cell leukemia (pPCL), with a life expectancy of more than 3 months.

The primary objective is to assess the safety and efficacy of CARTBCMA ARI0002h (cesnicabtagene autoleucel) after initial treatment to induce response in patients with newly diagnosed primary plasma cell leukaemia.

Being tested
ARI0002h
Medical subject headings
Leukemia, Plasma Cell

What participants receive

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

  • ARI0002hGenetic

    • Treatment with ARI0002h cells
    • Other names: CARTBCMA_J22.9-h:CD8TM:4-1BB:CD3. Adult differentiated autologous T cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-BCMA (TNFRSF17) specificity conjugated to the 4-1BB co-stimulatory domain and the CD3z signalling domain that has been humanized.
Study groups in NCT06830733
Study groupRoleWhat they receive
ARI0002hExperimentalARI0002 will be administered intravenously in two doses. First dose will b e a fractionated infusion of three doses of the investigational medicinal product (day 0: 10% dose, day 3: 30% dose, day 7: 60% dose), and a second adminsitration as a single dose at 2 months after the first in those patients who have achieved at least a minimal response, have not presented PCL progression after the first infusion or serious complications after the first infusion.
Receives: Genetic: ARI0002h

What is being measured

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

  1. Overall response rate (ORR)

    Overall response rate (ORR) during the initial 3 months after the first infusion (at least presenting a partial response according to the International Myeloma Working Group criteria).

    Measured: 3 months after the first infusion

  2. Rate of patients who develop cytokine release syndrome and/or neurological toxicity

    Rate of patients who develop cytokine release syndrome and/or neurological toxicity in the first 30 days after CARTBCMA administration, according to the criteria and grading defined in the international consensus document

    Measured: 30 days after CARTBCMA administration

Secondary outcomes (17)

  1. Duration of response

    Duration of response calculated from the time of first disease evaluation

    Measured: From day 28 after infusion to study completion, an average of 24 months

  2. Response rates

    Response rates

    Measured: During the first year after administration

  3. Complete response rate

    Complete response rate

    Measured: at 3, 6, and 12 months after the first infusion

  4. Overall response rate

    Overall response rate

    Measured: at 6, and 12 months after the first infusion

  5. Time to complete response

    Time to complete response

    Measured: through study completion, an average of 24 months

  6. Time to best response

    Time to best response

    Measured: through study completion, an average of 24 months

  7. MRD negative rate in bone marrow

    MRD negative rate in bone marrow by flow cytometry

    Measured: at 3, 6 12 and 24 months

  8. Response rate of extramedullary disease

    Response rate of extramedullary disease by PET-CT

    Measured: at 3, 6 and 12 months.

  9. Progression-free survival

    defined as the time between administration of ARI0002h and disease progression or death. Patients who are alive and in complete remission will be censored at the time of the last follow-up.

    Measured: through study completion, an average of 24 months

  10. Progression-free survival at 12 months after the first administration

    Progression-free survival at 12 months after the first administration, defined as the time elapsed between the administration of ARI0002h and disease progression or death. Patients who are alive and in complete remission will be censored at the time of the last follow-up.

    Measured: 12 months

  11. Overall survival

    Overall survival, defined as the time between infusion of ARI0002h and death of the patient from any cause. Living patients will be censored at the time of last follow-up.

    Measured: through study completion, an average of 24 months

  12. Presence of infusion reactions

    Presence of infusion reactions, understood as the appearance of any of the following symptoms after the intravenous administration of CARTBCMA: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, rash or urticaria.

    Measured: through study completion, an average of 24 months

  13. Tumour lysis syndrome

    Tumour lysis syndrome

    Measured: through study completion, an average of 24 months

  14. Cytokine release syndrome

    Cytokine release syndrome. According to the criteria and grading defined in the international consensus document

    Measured: through study completion, an average of 24 months

  15. Neurological toxicity

    Neurological toxicity according to the criteria and grading defined in the international consensus document (Lee, Santomasso et al. 2019)

    Measured: through study completion, an average of 24 months

  16. Presence of prolonged cytopenias

    Presence of prolonged cytopenias, defined as a grade 4 decrease in peripheral blood neutrophil or platelet counts for more than 4 weeks after infusion.

    Measured: between 4 weeks after infusion and study completion

  17. Quality of life of patients

    Quality of life during the first year after infusion according to the Quality of life questionnaire 2008 EuroQol Group EQ-5D

    Measured: during the first year 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 posted17 Feb 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 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
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06830733
Sponsor's protocol ID
2024-515053-21-00
Acronym
GEM-PLASMACAR
Status last verified
Feb 2025
First submitted
20 Nov 2024
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ARI0002h in people with Leukemia, Plasma Cell, 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 7 inclusion and 15 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 25 Apr 2025. 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?

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?

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 Carlos Fernandez de Larrea, MD, PhD (+34932775400, cfernan1@clinic.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: 3 months after the first infusion). 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 NCT06830733.

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 25 Apr 2025.

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