A Phase 2 Multicohort Trial to Further Characterize the Efficacy and Safety of Ciltacabtagene Autoleucel
ESTADO CLÍNICO
Reclutando
FASE/S DEL ENSAYO
Fase II
PATOLOGÍA
Leucemia mieloide aguda, Mieloma Múltiple y otras gammapatías, --> Otros, Terapia celular y T-CARs, Trasplante de progenitores hematopoyéticos, Trombosis y Anticoagulantes, Linfoma Folicular, Enfermedad de células falciformes, Linfoma
CENTRO INVESTIGADOR
H.U. 12 de Octubre
INVESTIGADOR PRINCIPAL
Joaquin Martinez Lopez
FECHA DE APERTURA
Agosto, 2025
FECHA DE CIERRE
,
CRITERIOS DE INCLUSIÓN
1. At the time of informed consent, be 18 years of age (or at least the legal age of consent in the jurisdiction in which the study is taking place) but 80 years of age.
2. Documented diagnosis of NDMM according to the most recent IMWG diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy)
3. Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: -Advanced age; or -Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or -Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment.
4. Participant must have received induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled.Participants must have achieved PR to be enrolled on the most recent disease assessment.
5. ECOG Performance Status score of 0 or 1
6. Clinical laboratory values as defined in the protocol
2. Documented diagnosis of NDMM according to the most recent IMWG diagnostic criteria and measurable disease at diagnosis (prior to start of any anti-myeloma therapy)
3. Not considered a candidate for high-dose chemotherapy with stem cell transplantation due to: -Advanced age; or -Presence of comorbid condition(s) likely to have a negative impact on tolerability of high-dose chemotherapy with stem cell transplantation; or -Participant refusal of high-dose chemotherapy with stem cell transplantation as initial treatment.
4. Participant must have received induction therapy. Initially, only participants receiving triplet induction therapy with DRd or VRd will be enrolled. Only after sponsor notification, participants receiving quadruplet DVRd induction therapy may be enrolled.Participants must have achieved PR to be enrolled on the most recent disease assessment.
5. ECOG Performance Status score of 0 or 1
6. Clinical laboratory values as defined in the protocol
CRITERIOS DE EXCLUSIÓN
1. Prior systemic therapy for multiple myeloma or smoldering myeloma other than VRd, DRd or DVRd as per inclusion 4a and short course of corticosteroids . For participants who require emergency treatment, refer to protocol Section 4.4.
2. Radiation therapy for treatment of plasmacytoma within 14 days before enrollment. Palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment, if the radiation portal covered 5% of the bone marrow reserve
3. Frailty index of 2 according to Myeloma Geriatric Assessment score
4. The following cardiac conditions: - New York Heart Association stage III or IV congestive heart failure. - Myocardial infarction or coronary artery bypass graft 6 months prior to enrollment. - History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration. - History of severe non-ischemic cardiomyopathy. - Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition scan (performed 60 days prior to apheresis).
5. Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib.
6. Participants who require continuous supplemental oxygen.
2. Radiation therapy for treatment of plasmacytoma within 14 days before enrollment. Palliative radiation for pain control secondary to lytic lesion is allowed within 14 days of enrollment, if the radiation portal covered 5% of the bone marrow reserve
3. Frailty index of 2 according to Myeloma Geriatric Assessment score
4. The following cardiac conditions: - New York Heart Association stage III or IV congestive heart failure. - Myocardial infarction or coronary artery bypass graft 6 months prior to enrollment. - History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration. - History of severe non-ischemic cardiomyopathy. - Impaired cardiac function (LVEF <45%) as assessed by echocardiogram or multiple-gated acquisition scan (performed 60 days prior to apheresis).
5. Grade 2 or higher ongoing non-hematologic toxicity due to induction therapy, with the exception of grade 2 peripheral neuropathy due to bortezomib.
6. Participants who require continuous supplemental oxygen.
DESCRIPCIÓN
To characterize the efficacy of cilta-cel infusion following a fludarabine free LD regimen (Cohort A) or a low-dose cilta-cel infusion following a standard cyclophosphamide and fludarabine LD regimen (Cohort B)
PALABRAS CLAVE
antagonistas de la vitamin k, blastic plasmacytoid dendritic cell neoplasm (bpdcn), donor lymphocyte infusion, gene therapy, hematopoietic stem cell transplant, langerhans cell histiocytosis, mantle cell lymphoma, multiple myeloma, myeloma, non-langerhans cell histiocytosis, sickle cell disease, stem cell, vitamin k antagonist
