A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R/R Multiple Myeloma
Nanjing IASO Biotechnology Co., Ltd.
240 participants
Mar 27, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
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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
dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.
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
dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle: D1-D21 for DPd regimen, D1-D14 for PVd regimen.
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.
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.
Locations(28)
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NCT06464991