MedTrace Logo

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

NCT06464991 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-07-20

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Nanjing IASO Biotechnology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Gui Lu Qiu, PhD · Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

  • Zhen Cai, PhD · First Affiliated Hospital of Zhejiang University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-27
Primary Completion
2027-08-31
Completion
2030-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06464991 on ClinicalTrials.gov