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Relapsed/Refractory Multiple MyelomaPhase 1/2FUMANBA-04NCT07510100

Eque-cel for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

A Phase 1/2 study testing Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel) in people with Relapsed/Refractory Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 3 sites in Japan.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Relapsed/Refractory Multiple Myeloma
What is being tested?
Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesJapan
Study dates
10 May 2026to 31 Jan 2030
Phase
Phase 1/2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Aged 18 to 70 years, male or female.
  • 2. Patients with a confirmed diagnosis of relapsed/refractory multiple myeloma according to the IMWG diagnostic criteria.
  • 3. Patients who have received at least three prior treatment regimens (including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibody-based chemotherapy regimens) and have documented disease progression during or within 12 months of their most recent anti-myeloma treatment.
  • 4. Patients with measurable disease at screening, as determined by any of the following criteria:
  • Serum M-protein level: IgG type M-protein level ≥ 10 g/L, IgA, IgD, IgE, IgM type M-protein level ≥ 5 g/L
  • Urinary M-protein level ≥ 200 mg/24 hours
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  • 5. Light-chain multiple myeloma without measurable M protein in serum or urine: involved serum free light chain ≥ 100 mg/L with an abnormal serum κ/λ free light chain ratio. ECOG PS 0 or 1.
  • 6. Patients must have adequate organ function and meet all of the following pre-enrollment laboratory test results:
  • Hematological Tests:
  • Absolute Neutrophil Count (ANC) ≥ 1×109/L (Supportive growth factors are permitted, but supportive treatment must not have been administered within 7 days prior to the laboratory test)
  • Absolute Lymphocyte Count (ALC) ≥ 0.3×109/L
  • Platelet Count ≥ 50×109/L (Supportive transfusions must not have been administered within 7 days prior to the laboratory test)
  • Hemoglobin ≥ 60 g/L (Red blood cell [RBC] transfusions must not have been administered within 7 days prior to the laboratory test, but recombinant human erythropoietin is permitted)
  • Liver Function:
  • ALT and AST ≤ 2.5×upper limit of normal (ULN)
  • Serum Total Bilirubin ≤ 1.5 x ULN Renal Function: Creatinine clearance (CrCl) calculated using the Cockcroft-Gault formula ≥ 40 mL/min CrCl = (140 - age) × weight (kg) × [0.85 for women] / 72 × [ serum creatinine (mg/dL)]
  • Coagulation function:
  • Fibrinogen ≥ 1.0 g/L
  • Activated partial thromboplastin time (APTT) ≤ 1.5× ULN
  • Prothrombin time (PT) ≤ 1.5× ULN Corrected serum calcium ≤11 mg/dL Oxygen saturation > 91% Left ventricular ejection fraction (LVEF) ≥ 50%.
  • 7. Female patients of childbearing potential or male patients with partners of childbearing potential agree to use effective contraception (safe-day contraception not included) throughout the study period from screening through one year after Eque-cel infusion.
  • "Effective contraceptive methods" specifically refers to: User-independent methods: 1) Intrauterine devices, intrauterine hormone-releasing systems; 2) Partner has undergone vasectomy.
  • User-dependent methods: 1) Combined hormonal contraception (containing estrogen and progestin) with ovulation suppression:
  • Oral; 2) Progestin-only hormonal contraception with ovulation suppression ( oral).
  • -8. Prior to screening, subjects must manually sign an Institutional Review Board-approved ICF.

Who cannot join

  • 1. Patients with graft-versus-host disease (GVHD) or requiring long-term use of immunosuppressants.
  • 2. Patients with a history of BCMA-targeted therapy.
  • 3. Patients who have undergone autologous hematopoietic stem cell transplantation (auto-HSCT) within 12 weeks prior to apheresis, two auto-HSCTs, or prior allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • 4. Patients who have received prior anti-myeloma therapy, including:
  • Monoclonal antibody therapy within 21 days prior to apheresis.
  • Cytotoxic chemotherapy or proteasome inhibitor therapy within 14 days prior to apheresis.
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  • Immunomodulatory therapy within 7 days prior to apheresis.
  • Other anti-myeloma therapy within 14 days or within 5 half-lives (whichever is longer) prior to apheresis.
  • 5. Use of systemic corticosteroids at a therapeutic dose (defined as >20 mg/day of prednisone or equivalent) within 7 days prior to apheresis.
  • Physiological replacement steroids, topical steroids, and inhaled steroids are permitted.
  • 6. Patients with uncontrolled hypertension despite medical therapy.
  • 7. Severe cardiac disease, including but not limited to unstable angina, myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] grade ≥ III), and severe arrhythmia.
  • 8. Unstable systemic disease as determined by the investigator, including but not limited to severe liver, renal, or metabolic disease requiring treatment.
  • 9. Patients with malignancies other than multiple myeloma (MM) within 5 years prior to screening.
  • excluding adequately treated cervical epithelial cell adenocarcinoma, basal cell carcinoma or squamous cell skin cancer, localized prostate cancer after curative surgery, and ductal carcinoma in situ after curative surgery.
  • 10. Patients with a history of solid organ transplantation.
  • 11. Patients with suspected or confirmed central nervous system infiltration by plasma cell neoplasms.
  • 12. Multiple myeloma patients with extramedullary lesions (excluding those with only paraskeletal extramedullary lesions where the single largest transverse diameter is ≤3cm).
  • 13. Multiple myeloma patients with concomitant plasma cell leukemia (peripheral blood plasma cell count ≥5%).
  • 14. Major surgery within 2 weeks prior to apheresis or planned surgery within 2 weeks after study treatment (subjects scheduled for local anesthesia surgery may participate in this study).
  • 15. Received investigational drugs from other interventional clinical trials within 1 month prior to signing the Informed Consent Form (ICF).
  • 16. Patients with an uncontrolled active infection (excluding CTCAE Grade 2 urinary tract infection or respiratory infection) within 7 days prior to apheresis.
  • 17. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with detectable hepatitis B virus (HBV) DNA in peripheral blood; Hepatitis C virus (HCV) positive with hepatitis C virus (HCV) RNA positive in peripheral blood; Human Immunodeficiency Virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA test positive; Syphilis test positive.
  • 18. Pregnant or lactating women.
  • 19. Patients with psychiatric disorders, impaired consciousness, or central nervous system disease.
  • 20. Patients whose non-hematologic toxicities from previous antimyeloma therapy have not resolved to baseline or Grade ≤ 1 (NCI-CTCAE v5.0) (excluding alopecia and Grade 2 peripheral neuropathy).
  • 21. Other conditions deemed ineligible for enrollment by the investigator.

Trial locations and contacts

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

Japan3 sites

  • Institute of Science Tokyo Hospital

    Bunkyo-ku, Tokyo, 113-8519

    Takehiko Mori ph.D

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

    Tadao Ishida ph.D

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

    Takashi Hamada

Other trials in Japan

About this study

Official title: A Phase I/II Clinical Study of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) for the Treatment of Patients With Relapsed/Refractory Multiple Myeloma

This study is a single-armed, open-label, multicenter Phase 1/2 study to evaluate the efficacy and safety of Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Equecabtagene Autoleucel) in subjects with relapsed and refractory Multiple Myeloma.

Read the detailed description

This study is divided into two stages: Part 1 and Part 2. Part 1: For exploratory research purposes, no more than 3 subjects will be enrolled at an exploratory dose.

Part 2: The purpose of this phase is to explore the efficacy of Equecabtagene Autoleucel (Eque-cel) as a last-line treatment for RRMM and further confirm its safety.

In this Study，Leukapheresis procedure will be performed to manufacture Eque-cel modified T cells. Bridging therapy is allowed between PBMC collection and lymphodepletion. Lymphodepletion with fludarabine and cyclophosphamide is performed for three consecutive days. After 1-day rest, subjects will receive a single dose infusion of Eque-cel at 1.0 x 10^6 CAR+ T cells/Kg or 0.5 x 10^6 CAR+ T cells/Kg（if all three subjects in Part 1 experience the Toxicity Requiring Dose Reduction）. Subjects will be followed in the study for a minimum of 2 years after Eque-cel infusion.

Being tested
Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel)
Keywords
Relapsed/Refractory, Multiple Myeloma, BCMA, CAR-T
Medical subject headings
Multiple Myeloma, Recurrence

What participants receive

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

  • Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel)Drug

    Eque-cel consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that contains a unique CAR structure with a fully human single-chain variable fragment (scFv).

Study groups in NCT07510100
Study groupRoleWhat they receive
Eque-cel in relapsed and refractory multiple myeloma patientsExperimentalEque-cel will be infused at 1.0 x 10^6 CAR+ T cells or 0.5 x 10^6 CAR+ T cells/Kg（if all three subjects in Part 1 experience the Toxicity Requiring Dose Reduction）after receiving lymphodepleting chemotherapy.
Receives: Drug: Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel)

What is being measured

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

  1. Safety endpoint (Part 1)- Adverse Event（AEs）

    Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to the criteria of 2019 ASTCT criteria).

    Measured: up to 2 years from Eque-cel infusion

  2. Safety endpoint (Part 1)-CRS

    Incidence and severity of cytokine release syndrome (CRS； based on the 2019 ASTCT criteria）

    Measured: up to 2 years from Eque-cel infusion

  3. Safety endpoint (Part 1)-ICANS

    Incidence and severity of immune effector cell-associated neurotoxicity syndrome (ICANS).( based on the 2019 ASTCT criteria)

    Measured: up to 2 years from Eque-cel infusion

  4. Efficacy endpoint (Part 2): Independent Review Committee (IRC)-assessed ORR

    Rate of best response (PR, very good PR, CR, sCR) after Eque-cel infusion in all subjects at the time the last subject completed the 6-month follow-up.

    Measured: up to 2 years from Eque-cel infusion

Secondary outcomes (19)

  1. Safety endpoint (Part 2)- Adverse Event（AEs）

    Incidence and severity of adverse events as assessed by NCI-CTCAE v5.0 (except CRS and ICANS assessed according to 2019 ASTCT criteria).

    Measured: up to 2 years from Eque-cel infusion

  2. Efficacy endpoint -Investigator-assessed overall response rate (ORR)

    Rate of best response (PR, very good PR, CR, sCR) after Eque-cel infusion for all subjects at the time the last subject completed the 6-month follow-up.

    Measured: up to 2 years from Eque-cel infusion

  3. Efficacy endpoint -IRC- and investigator-assessed ORR

    Rate of best response (PR, VGPR, CR, sCR) within 1 month, 3 months, and 6 months after Eque-cel infusion.

    Measured: up to 2 years from Eque-cel infusion

  4. Efficacy endpoint -IRC and investigator-assessed duration of response (DOR)

    The period from the first response (PR, VGPR, CR, sCR) to the date of the first documented evidence of disease progression or death from any cause, as defined by the IMWG criteria after treatment.

    Measured: up to 2 years from Eque-cel infusion

  5. IRC and investigator-assessed time to response (TTR)

    The period from Eque-cel infusion to the date of the first documented response (PR or better).

    Measured: up to 2 years from Eque-cel infusion

  6. IRC and investigator-assessed time to complete response (TTCR)

    The period from Eque-cel infusion to the date of complete response (CR) or stringent complete response (sCR).

    Measured: up to 2 years from Eque-cel infusion

  7. Minimal residual disease (MRD) assessment by flow cytometry

    The proportion of subjects achieving MRD negativity and the duration of MRD negativity.

    Measured: up to 2 years from Eque-cel infusion

  8. IRC and investigator-assessed progression-free survival (PFS)

    The period from Eque-cel infusion to the date of first disease progression or death from any cause.

    Measured: up to 2 years from Eque-cel infusion

  9. Overall survival (OS)

    The period from Eque-cel infusion to death from any cause.

    Measured: up to 2 years from Eque-cel infusion

  10. Pharmacokinetic Endpoint-Cmax

    The maximum concentration (Cmax) of BCMA CAR-T cells in peripheral blood after Eque-cel infusion.

    Measured: up to 2 years from Eque-cel infusion

  11. Pharmacokinetic Endpoint-Tmax

    The time for BCMA CAR-T cells to reach the maximum concentration (Tmax) after Eque-cel infusion.

    Measured: up to 2 years from Eque-cel infusion

  12. Pharmacokinetic Endpoint-AUC

    Area under the curve of 28, 90 days and the last time point of PK measurement (AUC0-28d, AUC0-90d, AUC0-last) for BCMA CAR-T cells.

    Measured: up to 2 years from Eque-cel infusion

  13. Pharmacokinetic Endpoint-Cmax

    The maximum concentration (Cmax) of lentiviral vector copy number (VCN) in peripheral blood after Eque-cel infusion.

    Measured: up to 2 years from Eque-cel infusion

  14. Pharmacokinetic Endpoint-Tmax

    The time for lentiviral vector copy number (VCN) to reach the maximum concentration (Tmax) after Eque-cel infusion.

    Measured: up to 2 years from Eque-cel infusion

  15. - Pharmacokinetic Endpoint-AUC

    Area under the curve of 28, 90 days and the last time point of PK measurement (AUC0-28d, AUC0-90d, AUC0-last) for lentiviral vector copy number (VCN).

    Measured: up to 2 years from Eque-cel infusion

  16. Pharmacodynamic Endpoint-sBCMA

    The concentration of soluble BCMA in peripheral blood .

    Measured: up to 2 years from Eque-cel infusion

  17. Pharmacodynamic Endpoint-C-reactive protein (CRP)

    Changes in the levels of CRP.

    Measured: up to 2 years from Eque-cel infusion

  18. Pharmacodynamic Endpoint -Ferritin

    Changes in the levels of Ferritin.

    Measured: up to 2 years from Eque-cel infusion

  19. Pharmacodynamic Endpoint -Interleukin-6 (IL-6)

    Changes in the levels of IL-6.

    Measured: up to 2 years from Eque-cel infusion

Timeline

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

  1. First posted3 Apr 2026
  2. Study start10 May 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Jan 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07510100
Sponsor's protocol ID
CT103AJ001
Acronym
FUMANBA-04
Status last verified
Mar 2026
First submitted
10 Mar 2026
Last updated
3 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fully Human BCMA Chimeric Antigen Receptor Autologous T Cell Injection (Eque-cel) in people with Relapsed/Refractory Multiple Myeloma, run by Nanjing IASO Biotechnology Co., Ltd. at 3 sites in Japan.

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 25 inclusion and 27 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: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety endpoint (Part 1)- Adverse Event（AEs） (time frame: up to 2 years from Eque-cel infusion). The study lists 4 primary outcomes in all. 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 NCT07510100.

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 3 Apr 2026.

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