RecruitingPhase 2NCT07045909

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

A Phase 2, Open-label, Multicenter Multi-cohort Study to Evaluate the Efficacy and Safety of Anitocabtagene Autoleucel in Participants With Newly Diagnosed Multiple Myeloma


Sponsor

PETHEMA Foundation

Enrollment

30 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if anitocabtagene autoleucel following induction therapy works to treat adult participants with newly diagnosed multiple myeloma. The main objectives of this clinical trial are: * To determine the incidence and severity of all adverse events (AEs). * To determine the proportion of patients achieving undetectable minimal residual disease (uMRD) negative-CR rate (minimum 10 to -5) at 12 months (+/- 3 months) after enrollment. Participants will receive induction therapy with a quadruplet regimen including a proteasome inhibitor (Bortezomib \[V\]), immunomodulatory drug (Lenalidomide \[R\]), dexamethasone \[d\] and anti-CD38 monoclonal antibody (Daratumumab \[D\] or Isatuximab \[Isa\]) followed by anitocabtagene autoleucel. Participants in Cohorts A and B will receive lenalidomide maintenance therapy following infusion with anitocabtagene autoleucel.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called anitocabtagene autoleucel as a first-line treatment for newly diagnosed multiple myeloma (a cancer of plasma cells in the bone marrow). CAR-T therapy involves engineering a patient's own immune cells to attack cancer cells. The study tests different patient groups based on age and transplant eligibility. **You may be eligible if...** - You are 18 or older, newly diagnosed with multiple myeloma - You have measurable disease on standard lab tests - Your general health score (ECOG) is 0 or 1 - You have adequate heart, kidney, and liver function - For one group (Cohort A): you are 70 or younger; for other groups: 80 or younger **You may NOT be eligible if...** - You have already received treatment for multiple myeloma (except the induction regimen specified) - You have severe heart disease or significantly reduced heart function - You have uncontrolled infections or serious fluid around the lungs - You are pregnant or breastfeeding - You have had a prior stroke or serious bleeding within the past year Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

Daratumumab will be administered by subcutaneous (SC) injection.

DRUGIsatuximab

Isatuximab will be administered IV.

DRUGBortezomib

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

DRUGLenalidomide

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

DRUGCyclophosphamide

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

DRUGFludarabine

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

DRUGAnitocabtagene Autoleucel

Single infusion IV


Locations(10)

Hospital Germans Trias i Pujol (ICO BADALONA)

Badalona, Spain

H. Clinic de Barcelona

Barcelona, Spain

H. 12 de Octubre

Madrid, Spain

H. Ramón y Cajal

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Clinico Universitario Salamanca

Salamanca, Spain

H. Marqués de Valdecilla

Santander, Spain

C H Santiago de Compostela

Santiago de Compostela, Spain

Complejo Hosp. Regional Virgen del Rocío

Seville, Spain

Hospital Universitario y Politécnico La Fe de Valencia

Valencia, Spain

View Full Details on ClinicalTrials.gov

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NCT07045909