NCT07045909 - Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma (GEM-AnitoFIRST) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

March 31, 2028

Study Completion Date

March 31, 2030

Conditions

De Novo Multiple MyelomaAnitocabtagene Autoleucel

Interventions

DRUG

Daratumumab

Daratumumab will be administered by subcutaneous (SC) injection.

DRUG

Isatuximab

Isatuximab will be administered IV.

DRUG

Bortezomib

Bortezomib dose will be calculated using the patient's actual body surface area at baseline and will be administered by SC injection.

DRUG

Lenalidomide

Lenalidomide will be administered by oral route (all cohorts at induction, and cohorts A and B at maintenance).

DRUG

Cyclophosphamide

As part of lymphodepleting therapy before CAR-T manufacture, administered IV.

DRUG

Fludarabine

As part of lymphodepleting therapy before CAR-T manufacture, administered IV

DRUG

Anitocabtagene Autoleucel

Single infusion IV

Trial Locations (10)

37007

RECRUITING

Hospital Clinico Universitario Salamanca, Salamanca

41013

RECRUITING

Complejo Hosp. Regional Virgen del Rocío, Seville

Unknown

RECRUITING

Hospital Germans Trias i Pujol (ICO BADALONA), Badalona

RECRUITING

H. Clinic de Barcelona, Barcelona

RECRUITING

H. 12 de Octubre, Madrid

RECRUITING

H. Ramón y Cajal, Madrid

RECRUITING

Clinica Universidad de Navarra, Pamplona

RECRUITING

H. Marqués de Valdecilla, Santander

RECRUITING

C H Santiago de Compostela, Santiago de Compostela

RECRUITING

Hospital Universitario y Politécnico La Fe de Valencia, Valencia

All Listed Sponsors

lead

PETHEMA Foundation

OTHER