A Phase 1/2 interventional study of Equecabtagene Autoleucel Injection (Eque-cel) in Refractory Immune-mediated Necrotizing Myopathy, sponsored by Nanjing IASO Biotechnology Co., Ltd.. Not yet recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.
Sponsored by Nanjing IASO Biotechnology Co., Ltd. · Phase 1/2, Interventional, and Treatment
This is an open-label, single-arm Phase I/II clinical study to evaluate the efficacy and safety of Eque-cel Injection in patients with refractory immune-mediated necrotizing myopathy.
This study is an open-label, single-arm Phase I/II clinical trial evaluating the safety and efficacy of Eque-cel in subjects with immune-mediated necrotizing myopathy (IMNM). The study consists of two phases: Phase I and Phase II. The Phase I component will evaluate the safety, tolerability and preliminary efficacy of Eque-cel to identify the recommended Phase 2 dose (RP2D). Following RP2D determination from Phase I, the Phase II stage will enroll additional subjects at this dose level to confirm the efficacy of Eque-cel injection in patients with IMNM. All subjects will undergo a primary follow-up period of 2 years after infusion of Eque-cel injection, followed by long-term follow-up extending up to 15 years.
232 studies on the registry are indexed under Muscular Diseases; 54 are open to participants now.
This study's planned enrollment of 27 is below the median of 38 across 134 interventional studies indexed under Muscular Diseases.
Browse Muscular Diseases studies →Nanjing IASO Biotechnology Co., Ltd. is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eligible subjects will receive single intravenous infusion of Eque-cel Injection after successful screening and baseline assessment. Eque-cel Injection will be infused at 1.0 x 10\^6 CAR-T cells/kg or 0.5 x 10\^6 CAR-T cells/kg。
Drug: Equecabtagene Autoleucel Injection (Eque-cel)
Eque-cel is a personalized, BCMA-targeted gene-modified autologous T-cell immunotherapy product capable of recognizing and eliminating both malignant and normal cells expressing BCMA. The CAR specifically identifies BCMA via a fully human single-chain variable fragment (scFv) with low immunogenicity, activates, proliferates, secretes cytokines, and kills target cells through the CD3ζ domain, while enhancing CAR-T expansion and persistence via 4-1BB costimulation signaling. Eque-cel demonstrates high affinity for the BCMA antigen both in vitro and in vivo, as well as efficient killing of antigen-loaded cells.
Also known as: FUCASO
Phase I: Safety endpoint - Adverse Events (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).
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I: Safety endpoint-incidence of Dose-limiting toxicity (DLT)
Percentage of participants who experienced DLT within 28 days after Eque-cel administration.
Time frame: Time Frame: up to 28 days from Eque-cel Injection infusion
Phase II: Efficacy endpoint- TIS response
Proportion of participants achieving TIS response
Time frame: up to the 2 years after Eque-cel Injection infusion
Phase I: Efficacy endpoint -TIS response
Proportion of participants achieving TIS response
Time frame: up to the 2 years after Eque-cel Injection Infusion
Phase II:Efficacy endpoint -Proportion of participants achieving minimal improvement response (TIS ≥ 20 points)
Defined as achieving The Total Improvement Score (TIS)≥ 20 points (minimum improvement)
Time frame: From baseline to 12 months after Eque-cel Injection Infusion
Phase I/II:Efficacy endpoint -Change in mean Total Improvement Score (TIS) value
Defined as achieving the Total Improvement Score (TIS)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -The changes in PtGA scores
The PhGA scale will be completed by patients at each study visit.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -The changes in PhGA scores
The PhGA scale will be completed by investigators at each study visit.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint-MMT-8
The changes in Manual Muscle Testing-8 (MMT-8) As measured by testing proximal muscles.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -HAO Scale
HAQ will be completed by subjects at each study visit.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -CK
Changes in the levels of Creatine Kinase (CK)
Time frame: up to 2 years from Eque-cel Injection infusion
The changes in MDAAT scores
MDAAT will be completed by investigators at each study visit.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II:Efficacy endpoint -hormone dosage reduction
The proportion of subjects whose hormone dosage reduction.
Time frame: From baseline to 6 and 12 months after Eque-cel Injection Infusion
Phase II:Safety endpoint - Adverse Events (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)
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Cmax (CAR-T cells)
The maximum concentration (Cmax) of BCMA CAR-T in peripheral blood after CAR-T infusion.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Tmax (CAR-T cells)
The time for BCMA CAR-T to reach the maximum concentration (Tmax) after CAR-T infusion.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - AUC (CAR-T cells)
Area under the curve of 28 days, 90 days and the last time point. (AUC0-28d, AUC0-90,AUC0-last) for BCMA CAR-T.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Cmax (VCN)
The maximum concentration (Cmax) of lentiviral vector copy number (VCN) in peripheral blood after infusion.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - Tmax (VCN)
The time for VCN to reach the maximum concentration (Tmax) after infusion.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacokinetic Endpoint - AUC (VCN)
Area under the curve of 28 days, 90 days and the last time point (AUC0-28d, AUC0-90d, AUC0-last) for VCN.
Time frame: up to 2 years from Eque-cel Injection infusion
hase I/II Pharmacodynamic Endpoint - inflammatory markers
Changes in levels of inflammatory markers, including CRP, Ferritin, and IL-6.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacodynamic Endpoint - Serum immunoglobulin
Changes in serum immunoglobulin (IgG, IgA, IgM) levels from baseline.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Pharmacodynamic Endpoint-sBCMA
The concentration of soluble BCMA in peripheral blood of experimental group at each time point.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II- Immunogenicity
Prevalence and titer of confirmed human anti-CAR antibodies in peripheral blood.
Time frame: up to 2 years from Eque-cel Injection infusion
Phase I/II Replication competent lentivirus (RCL)
Prevalence of replication-competent lentivirus (RCL) in peripheral blood.
Time frame: up to 2 years from Eque-cel Injection infusion
Plan to share: No
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Studies of the drug tested here: Equecabtagene autoleucel
Nanjing IASO Biotechnology Co., Ltd.