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Evaluating Eque-cel for treating lenalidomide-refractory multiple myeloma

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

Phase 3 Interventional Nanjing IASO Biotechnology Co., Ltd. · NCT06464991

This study is testing a new treatment called eque-cel to see if it can help people with multiple myeloma who haven't responded to standard medications.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment240 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorNanjing IASO Biotechnology Co., Ltd. Industry-sponsored
Drugs / interventionstocilizumab, chemotherapy, cyclophosphamide, fludarabine, CAR-T, chimeric antigen receptor
Locations28 sites (Beijing and 27 other locations)
Trial IDNCT06464991 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, controlled, open-label phase III clinical study aims to assess the efficacy of Equecabtagene Autoleucel Injection (eque-cel) compared to standard therapy in patients with lenalidomide-refractory relapsed/refractory multiple myeloma (RRMM) who have undergone 1-2 lines of prior treatment. Participants will be screened and randomized into either the experimental group receiving eque-cel or the control group receiving standard therapies such as Daratumumab, Pomalidomide, Bortezomib, and Dexamethasone. The study will monitor safety, efficacy, and pharmacokinetics over approximately six years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a diagnosis of multiple myeloma who have received 1-2 lines of therapy and are lenalidomide-refractory.

Not a fit: Patients who have not been previously treated for multiple myeloma or those with an ECOG score greater than 1 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with lenalidomide-refractory multiple myeloma.

How similar studies have performed: Other studies involving CAR-T therapies targeting BCMA have shown promising results, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. 18 to 75 years of age (inclusive of critical values), either gender.
2. 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.
3. Subjects was lenalidomide-refractory during prior therapy.
4. ECOG score of 0 or 1.
5. Subjects must have appropriate organ function and meet all of the following laboratory test results before enrollment:

(1) 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.

Exclusion Criteria:

1. 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.
2. 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).
3. 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.
4. Significant cardiac disorder.
5. Unstable systemic disease as judged by the investigator: including but not limited to severe liver, renal, or metabolic disease requiring medication.
6. 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;
7. 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.
8. Subjects suspected or confirmed to have central nervous system involvement of MM during the screening period.
9. 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.
10. 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.
11. 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).
12. Subject with uncontrollable infection.
13. 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.
14. Pregnant or breastfeeding women.
15. The subject has a history of central nervous system disorder within 6 months prior to signing the informed consent form.
16. 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).
17. Subjects had other conditions that the investigator considered unsuitable for enrollment.

Where this trial is running

Beijing and 27 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaEque-cel
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.