Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06830733

Noch nicht rekrutierend

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

Interventionsstudie

Phase 2

Hospital Clínico Universitario Virgen de la Arrixaca

Sponsor: Fundacion Clinic per a la Recerca Biomédica

Zuletzt aktualisiert: 25. April 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Behandlungskategorie

Genetisch

Erforderliche Mutationen

Keine

Studie gestartet

26. April 2025

Zuletzt vom Sponsor aktualisiert

25. April 2025

Voraussichtlicher Abschluss

1. Dezember 2025

Studienkontakt

Name:Carlos Fernandez de Larrea, MD, PhD

E-Mail:cfernan1@clinic.cat

Telefon:+34932775400

Name:Maria Joyera

E-Mail:joyera@recerca.clinic.cat

Telefon:+34932775400

Eignung

Einschlusskriterien

1. 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).

2. 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".

3. ECOG Performance Status from 0 to 2

4. Life expectancy greater than 3 months.

5. Adequate venous access and absence of contraindications for lymphoapheresis.

6. Patients who, after being informed, give their consent by signing the Informed Consent Document.

7. Up to two cycles of previous treatment for symptomatic control will be allowed before inclusion.

Ausschlusskriterien

1. No previous treatments, except for induction therapy for primary plasma cell leukemia.

2. Administration of any anti-BCMA therapy as part of induction

3. Not having achieved at least a minimal response with induction treatment (IMWG criteria)

4. Absolute lymphocyte count <0.1x109/L

5. Active immunosuppressive therapy except for prednisone 10 mg/day (or equivalent).

6. 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.

7. Active infection requiring treatment.

8. Active HIV, HBV, or HCV infection.

9. Uncontrolled medical illness

10. 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)

11. Previous diagnosis of symptomatic AL amyloidosis,

12. Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at the screening phase.

13. 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.

14. Men who are unable or unwilling to use highly effective contraceptive methods* from the beginning of the study to completion of the study.

15. Contraindication to receive lymphodepletive chemotherapy.

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Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer25

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung: ARI0002 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.

Interventionen:

ARI0002h

Ergebnismessungen

Primäre Ergebnismessungen

Overall response rate (ORR)3 months after the first infusion

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).

Rate of patients who develop cytokine release syndrome and/or neurological toxicity30 days after CARTBCMA administration

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

Sekundäre Ergebnismessungen

Duration of responseFrom day 28 after infusion to study completion, an average of 24 months

Duration of response calculated from the time of first disease evaluation

Response ratesDuring the first year after administration

Response rates

Complete response rateat 3, 6, and 12 months after the first infusion

Complete response rate

Overall response rateat 6, and 12 months after the first infusion

Overall response rate

Time to complete responsethrough study completion, an average of 24 months

Time to complete response

Time to best responsethrough study completion, an average of 24 months

Time to best response

MRD negative rate in bone marrowat 3, 6 12 and 24 months

MRD negative rate in bone marrow by flow cytometry

Response rate of extramedullary diseaseat 3, 6 and 12 months.

Response rate of extramedullary disease by PET-CT

Progression-free survivalthrough study completion, an average of 24 months

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.

Progression-free survival at 12 months after the first administration12 months

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.

Overall survivalthrough study completion, an average of 24 months

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.

Presence of infusion reactionsthrough study completion, an average of 24 months

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.

Tumour lysis syndromethrough study completion, an average of 24 months

Tumour lysis syndrome

Cytokine release syndromethrough study completion, an average of 24 months

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

Neurological toxicitythrough study completion, an average of 24 months

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

Presence of prolonged cytopeniasbetween 4 weeks after infusion and study completion

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

Quality of life of patientsduring the first year after infusion

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

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Studienzentren

Hospital Clínico Universitario Virgen de la Arrixaca

El Palmar, Murcia, ES

Name:Valentín Cabañas

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