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

ConditionMultiple Myeloma

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorNanjing IASO Biotechnology Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

18 to 75 years of age (inclusive of critical values), either gender.

The subject was previously diagnosed with multiple myeloma and had received 1-2 lines of therapy (including chemotherapy regimens based on proteasome inhibitors and immunomodulatory agents, with each line of therapy receiving at least 1 full cycle ; Documented disease progression during or within 12 months after the most recent anti-myeloma therapy.

Subjects was lenalidomide-refractory during prior therapy.

ECOG score of 0 or 1.

Disqualifiers

Subjects who have used or required long-term immune-suppressive agents (e.g., cyclosporine or systemic steroids) within 14 days prior to enrollment, but the use of physiological substitutes, intermittent, topical, and inhaled steroids is allowed.

Subjects who have undergone autologous haematopoietic stem cell transplantation (Auto-HSCT) within 12 weeks prior to randomization, or who have previously undergone allogeneic haematopoietic stem cell transplantation (Allo-HSCT).

Subjects received the following anti-tumor treatments before enrollment: (1)Treated with an immunomodulator within 7 days, or; (2)Received plasma exchange, radiotherapy (except local radiotherapy for myeloma-related bone lesions), cytotoxic chemotherapy, treatment with proteasome inhibitors or other investigational drug within 14 days, or; (3) Treatment with monoclonal antibody for multiple myeloma within 21 days, or; (4) Received other anti-cancer therapy within 14 days or at least 5 half-lives (whichever is shorter) prior to enrollment.

Significant cardiac disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: Experimental groupExperimental treatment 1 intervention

Group B: Control groupActive comparator 4 interventions

Trial outcomes

Primary outcomes

Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC)

The time from randomization to the first documented disease progression as determined by IRC or death due to any cause

Time frame