NCT06464991

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Nanjing IASO Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multiple myeloma (MM) is a malignant neoplasm of plasma cells that accounts for more than 10%-20% of hematologic malignancies worldwide, leading to marrow failure and bone destruction. Equecabtagene Autoleucel (eque-cel) is an autologous chimeric antigen receptor T-cell (CAR-T) therapy that targets B-cell maturation antigen (BCMA), which expressed on both mature B lymphocytes and malignant plasma cells. The primary objective for this study is to compare the efficacy of eque-cel versus standard therapy in lenalidomid-refractory RRMM. Subjects will undergo screening with informed consent. After enrollment, randomization will be conducted followed by study treatment in experimental or control group. A follow-up phase will include assessments for safety, efficacy evaluation and pharmacokinetics monitoring (experimental arm) . The duration of this trial is about 6 years.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Equecabtagene Autoleucel Injection	dosage form: injection, dosage: 1.0×10\^6 CAR-T/kg, frequency: single dose.
DRUG	Daratumumab	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
DRUG	Pomalidomide	dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle: D1-D21 for DPd regimen, D1-D14 for PVd regimen.
DRUG	Bortezomib	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.
DRUG	Dexamethasone	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.

Timeline

• Start date: 2024-03-27
• Primary completion: 2027-08-01
• Completion: 2030-12-01
• First posted: 2024-06-18
• Last updated: 2025-07-20

Locations

28 sites across 1 country: China