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

Sponsor
PETHEMA Foundation
Study ID
NCT07045909
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anitocabtagene Autoleucel
  • De Novo Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Daratumumab — DRUG
    Daratumumab will be administered by subcutaneous (SC) injection.
  • Isatuximab — DRUG
    Isatuximab will be administered IV.
  • Bortezomib — DRUG
    Bortezomib dose will be calculated using the patient's actual body surface area at baseline and will be administered by SC injection.
  • Lenalidomide — DRUG
    Lenalidomide will be administered by oral route (all cohorts at induction, and cohorts A and B at maintenance).
  • Cyclophosphamide — DRUG
    As part of lymphodepleting therapy before CAR-T manufacture, administered IV.
  • Fludarabine — DRUG
    As part of lymphodepleting therapy before CAR-T manufacture, administered IV
  • Anitocabtagene Autoleucel — DRUG
    Single infusion IV

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Jul 2025
Primary completion
Mar 31, 2028
Completion
Mar 31, 2030

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Cohort A participants will be transplant eligible. Cohort A participants will receive induction with 6 cycles D-VRd. After induction, lymphodepleting chemotherapy will be administered consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day intravenous (IV) daily for 3 days before administration of anitocabtagene autoleucel. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted. After lymphodepletion, participants will receive a single infusion of anitocabtagene autoleucel administered IV. After CAR T-cell infusion, cohort A participants will receive maintenance therapy with lenalidomide 10 mg daily for 2 years or until unacceptable toxicity, progression as per IMWG criteria, participant withdrawal of consent, death, or study completion, whichever occurs first.
  • Experimental: Cohort B
    Cohort B participants will not be transplant eligible. Cohort B participants will receive induction with 4 cycles Isa-VRd. After induction, lymphodepleting chemotherapy will be administered consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day IV daily for 3 days before administration of anitocabtagene autoleucel. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted. After lymphodepletion, participants will receive a single infusion of anitocabtagene autoleucel administered IV. After CAR T-cell infusion, cohort B participants will receive maintenance therapy with lenalidomide 10 mg daily for 2 years or until unacceptable toxicity, progression as per IMWG criteria, participant withdrawal of consent, death, or study completion, whichever occurs first.
  • Experimental: Cohort C
    Cohort C participants will not be transplant eligible. Cohort C participants will receive induction with 4 cycles Isa-VRd; 2 cycles followed by leukapheresis for T-cell collection to manufacture anitocabtagene autoleucel, followed by 2 additional cycles. After induction, lymphodepleting chemotherapy will be administered consisting of cyclophosphamide 300 mg/m2/day and fludarabine 30 mg/m2/day IV daily for 3 days (Days -5 through -3) before administration of anitocabtagene autoleucel. The fludarabine dose may be adjusted for renal function. Initiation of the 3-day lymphodepleting chemotherapy regimen on Day -7 or Day -6 prior to the anitocabtagene autoleucel infusion on Day +1 is permitted. After lymphodepletion, participants will receive a single infusion of anitocabtagene autoleucel administered IV with a dose of 115 x 10e6 (± 10 x 10e6) CAR+ viable T cells. After CAR T-cell infusion, cohort C participants will not receive maintenance therapy.

Primary Outcome Measure

Incidence and severity of all adverse events (AEs) [ Time Frame: 3 years ]

Central Contacts