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Multiple MyelomaPhase 3FUMANBA-03NCT06464991

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

A Phase 3 study testing Equecabtagene Autoleucel Injection, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 28 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Multiple Myeloma
What is being tested?
Equecabtagene Autoleucel Injection, Daratumumab and Pomalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
28 sitesChina
Study dates
27 Mar 2024to Dec 2030
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment:
  • Haematology: absolute neutrophil count (ANC) ≥1×10^9/L (support with growth factor is allowed, but must not have received supportive treatment within 7 days before the laboratory test); Absolute lymphocyte count (ALC) ≥0.3×10^9/L; Platelets ≥50×10^9 / L (must not have received platelet transfusion within 7 days prior to laboratory test); Hemoglobin ≥60g/L (must not have received red blood cells transfusion within 7 days prior to laboratory test); (2) Hepatic function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times of upper limit of normal (ULN); Serum total bilirubin ≤1.5 times of ULN; (3) Renal function: creatinine clearance (CrCl) calculated by Cockcroft-Gault formula ≥ 40 ml/min; (4) Coagulation: fibrinogen≥1.0 g/L; activated partial thromboplastin time (APTT) ≤ 1.5×ULN, pro-thrombin time (PT) ≤ 1.5 × ULN; (5) Pulse oxygen saturation > 91%; (6) Left ventricular ejection fraction (LVEF)≥50%;
  • 6. Subjects agree to use effective tools or drug contraception (excluding safe period contraception) after signing the informed consent form.
  • 7. Subjects must agree to sign or personally sign an ethics committee-approved informed consent form before starting any screening procedures.

Who cannot join

  • 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.
  • Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring medication.
  • The subject will not be able to participate in this study if the investigator determines that the subject meets any of the following conditions: (1) Subjects with a history of allergic reaction to the excipient components (DMSO and albumin) of Eque-cel, fludarabine, cyclophosphamide, tocilizumab, or; (2) Subjects who are intolerant to dexamethasone, or; (3) Subjects who have a Life-threatening allergy, hypersensitivity reaction, or intolerance to pomalidomide and/or its excipients (intolerance is defined as discontinuation of prior treatment due to any AE related to pomalidomide) or;
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  • Have malignancies other than multiple myeloma within 5 years before screening, excluding cervical carcinoma in situ after radical surgery, basal cell or squamous cell skin cancer, localized cancer of prostate after radical prostatectomy, breast ductal carcinoma in situ after radical mastectomy or carcinoma papillary thyroid after radical thyroidectomy.
  • Subjects suspected or confirmed to have central nervous system involvement of MM during the screening period.
  • Subjects with concurrent plasma cell leukemia(defined as plasma cell proportion in peripheral blood > 5%), Waldenström macroglobulinaemia, POEMS syndrome (polyneuropathy, organ hypertrophy, endocrinopathy, monoclonal protein and skin changes) or primary amyloidosis during screening period.
  • Have extramedullary multiple myeloma-extraosseous (EM-E); have multiple extramedullary multiple myeloma-bone related (EM-B) and the maximum transverse diameter of any lesion is >3cm; have a single EM-B and the maximum transverse diameter of the lesion is >3cm.
  • Had major surgery within 2 weeks prior to randomization or planned to have surgery within 2 weeks after study treatment (except for subjects who were scheduled to have surgery under local anesthesia).
  • Subject with uncontrollable infection.
  • Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) DNA quantification in peripheral blood was higher than the lower limit of detection; hepatitis C virus (HCV) antibody positive and hepatitis C virus (HCV) RNA positive in peripheral blood; Human immunodeficiency virus (HIV) antibody positive; Syphilis test positive; positive cytomegalovirus (CMV) DNA.
  • Pregnant or breastfeeding women.
  • The subject has a history of central nervous system disorder within 6 months prior to signing the informed consent form.
  • Non-hematological toxicity reactions due to prior treatment have not resolved to baseline or ≤ Grade 1 (NCI-CTCAE v5.0, alopecia, Grade 2 peripheral neuropathy were excepted).
  • Subjects had other conditions that the investigator considered unsuitable for enrollment.

Trial locations and contacts

28 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yue Wan contact

+86 025-58287610

yue.wan@iasobio.com

28 sites in 1 country

China28 sites, 28 recruiting

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing

    WenMing Chen

    Recruiting

  • Beijing GoBoard Boren Hospital

    Beijing

    Gang An

    Recruiting

  • Fu Xing Hospital, Capital Medical University

    Beijing

    Jin Lu

    Recruiting

  • Peking Union Medical College Hospital

    Beijing

    Jian Li

    Recruiting

  • Peking University First Hospital

    Beijing

    YuJun Dong

    Recruiting

  • Peking University Third Hospital

    Beijing

    HongMei Jing

    Recruiting

  • People's Hospital of Peking University

    Beijing

    Jin Lu

    Recruiting

  • The first hospital of Jilin University

    Changchun

    FengYan Jin

    Recruiting

  • West China School of Medicine, West China Hospital of Sichuan University

    Chengdu

    WenJiao Tang

    Recruiting

  • Xinqiao Hospital of AMU

    Chongqing

    YunJing Zeng

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou

    XiaoLei Wei

    Recruiting

  • Sun Yat-sen University Cancer Centre

    Guangzhou

    ZhongJun Xia

    Recruiting

  • Zhujiang Hospital of Southern Medical University Guangdong

    Guangzhou

    YanJie He

    Recruiting

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou

    Zhen Cai

    Recruiting

  • The Second Affiliated Hospital,Zhejiang University School of Medicine

    Hangzhou

    WenBin Qian

    Recruiting

  • Qilu Hospital of Shangdong University

    Jinan

    LuQun Wang

    Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang

    Fei Li

    Recruiting

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing

    Bin Chen

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    LiJuan Chen

    Recruiting

  • The Affiliated People's Hospital of Ningbo University

    Ningbo

    Ying Lu

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    JianQing Mi

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou

    ChengCheng Fu

    Recruiting

  • Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences

    Tianjing

    LuGui Qiu, PhD

    Recruiting

  • Tianjin Medical University General Hospital

    Tianjing

    Rong Fu

    Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou

    Songfu Jiang

    Recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    ChunRui Li

    Recruiting

  • Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

    Wuhan

    Heng Mei

    Recruiting

  • Henan Cancer Hospital Affilated Cancer Hospital of Zhengzhou University

    Zhengzhou

    BaiJun Fang

    Recruiting

Other trials in China

About this study

Official title: A Phase III Randomized, Controlled Study of Equecabtagene Autoleucel Injection in Subjects With Lenalidomide-Refractory R/R Multiple Myeloma

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.

Read the 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.

Being tested
Equecabtagene Autoleucel Injection, Daratumumab, Pomalidomide, Bortezomib, Dexamethasone
Keywords
Multiple Myeloma, Eque-cel
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Equecabtagene Autoleucel InjectionDrug

    Also called FUCASO

    dosage form: injection, dosage: 1.0×10^6 CAR-T/kg, frequency: single dose.

  • DaratumumabDrug

    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

  • PomalidomideDrug

    dosage form:capsule. doseage form: capsule. dose level: 4mg/d. frequency: every cycle: D1-D21 for DPd regimen, D1-D14 for PVd regimen.

  • BortezomibDrug

    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.

  • DexamethasoneDrug

    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 groups in NCT06464991
Study groupRoleWhat they receive
Experimental groupExperimentalDrug:Equecabtagene Autoleucel Injection
Receives: Drug: Equecabtagene Autoleucel Injection
Control groupActive comparatorDrug: Daratumumab, Bortezomib, Dexamethasone, Pomalidomide, DPd group: Daratumumab, Pomalidomide, Dexamethasone PVd group: Bortezomib, Dexamethasone, Pomalidomide
Receives: Drug: Daratumumab; Drug: Pomalidomide; Drug: Bortezomib; Drug: Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: up to 5 years from randomization

Secondary outcomes (16)

  1. Minimal Residual Disease (MRD) negativity rate at 12 months

    The proportion of subjects who achieve MRD negativity (using next-generation flow cytometry according to EuroFlow standard operating procedures) and complete response (CR) or better, as assessed by IRC, 12 months (±3 months) post-randomization

    Measured: up to 5 years from randomization

  2. Overall MRD negativity rate

    The proportion of subjects who achieve MRD negativity at any time after the date of randomization and before the initiation of subsequent therapy

    Measured: up to 5 years from randomization

  3. Duration of MRD negativity

    The time from first achievement of MRD negativity to the first subsequent positive MRD status

    Measured: up to 5 years from randomization

  4. Complete Response Rate（CRR）

    The proportion of subjects who achieve CR or better post-randomization among all randomized subjects

    Measured: up to 5 years from randomization

  5. Very good partial response or better response (≥VGPR) rate

    The proportion of subjects who achieve sCR, CR, or VGPR post-randomization among all randomized subjects

    Measured: up to 5 years from randomization

  6. Overall Response Rate（ORR）

    The proportion of subjects who achieve sCR, CR, VGPR, or PR post-randomization among all randomized subjects.

    Measured: up to 5 years from randomization

  7. Duration of Response (DOR)

    The time from the first date of initial documented response (≥PR) to the date of first disease progression or death from any cause, whichever occurs first, post-randomization

    Measured: up to 5 years from randomization

  8. Event-Free Survival (EFS)

    Time from randomization to the first occurrence of any of the following events: death, disease progression, initiation of a new anti-myeloma therapy, addition of other treatments, or occurrence of fatal or intolerable adverse effects

    Measured: up to 5 years from randomization

  9. Overall Survival（OS）

    Defined as the time from randomization to death due to any cause

    Measured: up to 5 years from randomization

  10. Time to Next Treatment（TTNT）

    Time from randomization to the initiation of a new subsequent anti-myeloma therapies

    Measured: up to 5 years from randomization

  11. Incidence of Adverse events

    Safety Endpoint

    Measured: up to 5 years from randomization

  12. Pharmacokinetic Endpoint-Cmax

    The maximum concentration (Cmax) of CAR VCN and BCMA CAR-T in peripheral blood after CAR-T infusion

    Measured: up to 5 years from Eque-cel infusion

  13. Pharmacokinetic Endpoint-Tmax

    the time for CAR VCN and BCMA CAR-T to reach the maximum concentration (Tmax) after CAR-T infusion

    Measured: up to 5 years from Eque-cel infusion

  14. Pharmacokinetic Endpoint-AUC

    Area under the curve of 29, 85, 169 days and the last time point of PK detection (AUC0-29d, AUC0-85d, AUC0-169d, AUC0-last) for CAR VCN; Area under the curve of 29 days (AUC0-29) for BCMA CAR-T.

    Measured: up to 5 years from Eque-cel infusion

  15. Pharmacodynamic Endpoint

    The concentration of soluble BCMA in peripheral blood of experimental group at each time point

    Measured: up to 5 years from Eque-cel infusion

  16. Health Related Quality of Life Endpoint

    Symptoms, function, and overall HRQoL were collected using the validated Patient-Reported Outcomes (PRO) questionnaire

    Measured: up to 5 years from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2024
  2. Study start27 Mar 2024
  3. Primary completionAug 2027 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06464991
Sponsor's protocol ID
CT103AC004
Acronym
FUMANBA-03
Status last verified
Jul 2025
First submitted
30 May 2024
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Equecabtagene Autoleucel Injection, Daratumumab and Pomalidomide in people with Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 28 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yue Wan (+86 025-58287610, yue.wan@iasobio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as assessed by Independent Review Committee (IRC) (time frame: up to 5 years from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06464991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2025; AzTrials last refreshed its copy on 31 Oct 2026.

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