A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)

Sponsor
Nanjing IASO Biotechnology Co., Ltd.
Study ID
NCT06464991
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Equecabtagene Autoleucel Injection — DRUG
    dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.
  • Daratumumab — DRUG
    dosage form: Injection dose level:16mg/kg frequency: 28days/cycle for DPd regimen * Cycle1-2：D1, D8, D15, D22； * Cycle3-6：D1, D15； * above Cycle7：D1
  • Pomalidomide — DRUG
    dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle: D1-D21 for DPd regimen, D1-D14 for PVd regimen.
  • Bortezomib — DRUG
    dosage form: subcutaneous injection. dose level: 1.3mg/m2. frequency: 21days/cycle for PVd regimen cycle 1-8: D1,D4, D8, D11； above cycle 9: D1, D8.
  • Dexamethasone — DRUG
    dosage form: oral or intravenus injection. dose level:20mg/d. frequency: for DPd: every cycle, D1, D2, D8, D9, D15, D16, D22, D23； for PVd: Cycle1-8：D1, D2, D4, D5, D8, D9, D11, D12; above Cycle 9: D1, D2, D8, D9.

Study Details

This is a multicenter, randomized, controlled, open-label, phase III clinical study to evaluate the efficacy of Equecabtagene Autoleucel Injection versus standard therapy in subjects with lenalidomid-refractory RRMM who have received 1-2 lines of prior therapy.

Key Dates

Start date
Mar 27, 2024
Status verified
Jul 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2030

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental group
    Drug:Equecabtagene Autoleucel Injection
  • Active Comparator: Control group
    Drug: Daratumumab, Bortezomib, Dexamethasone, Pomalidomide, DPd group: Daratumumab, Pomalidomide, Dexamethasone PVd group: Bortezomib, Dexamethasone, Pomalidomide

Primary Outcome Measure

Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC) [ Time Frame: up to 5 years from randomization ]

Central Contacts

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