Tests eque-cel cell therapy in adults with relapsed or refractory multiple myeloma

Trial details

Who runs it

Nanjing IASO Biotechnology Co., Ltd.

Trial code

NCT07510100

Record updated

3 April 2026

Original description

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 full original descriptionShow less

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.

Exclusion: 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; 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; 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; 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; 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; 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); 1. Patients with graft-versus-host disease (GVHD) or requiring long-term use of immunosuppressants; 2. Patients with a history of BCMA-targeted therapy; 6. Patients with uncontrolled hypertension despite medical therapy; 8. Unstable systemic disease as determined by the investigator, including but not limited to severe liver, renal, or metabolic disease requiring treatment; 10. Patients with a history of solid organ transplantation; 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; 19. Patients with psychiatric disorders, impaired consciousness, or central nervous system disease; 21. Other conditions deemed ineligible for enrollment by the investigator; 13. Multiple myeloma patients with concomitant plasma cell leukemia (peripheral blood plasma cell count ≥5%); 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); 18. Pregnant or lactating women.

Inclusion Criteria; 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; 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.

ClinicalTrials.gov NCT07510100