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Also known as CC-97540, BMS-986353, Zola-cel
Zolacabtagene autoleucel · 7 trials · 14 indications
The occurrence of DLT is the primary endpoint and will be assessed for all patients treated at the expansion dose.
This will be determined by the percentage of participants in treatment-free remission defined as a BVASv3 of 0 off immunosuppressive therapy.
For Cohorts 1 and 2
An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.ject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the sub
| Arm | Type | Description |
|---|---|---|
| Arm A: BMS-986353 | EXPERIMENTAL | - |
| Arm B: Standard of Care | EXPERIMENTAL | - |
| Cohort 1 Part A ITP | EXPERIMENTAL | - |
| Cohort 1 Part A AIHA | EXPERIMENTAL | - |
| Cohort 1 Part B | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| Administration of CC-97540 | EXPERIMENTAL | - |
| CC-97540 | EXPERIMENTAL | Prior to receiving CC-97540, participants will undergo lymphodepleting chemotherapy. Lymphodepleting chemotherapy is the combination of cyclophosphamide and fludarabine and will be administered intravenously. CC-97540 will be infused intravenously on day 0 only. |
| Administration of CC-97540 (RMS arm) | EXPERIMENTAL | - |
| Administration of CC-97540 (PMS arm) | EXPERIMENTAL | - |
| Administration of CC-97540 (MG arm) | EXPERIMENTAL | - |
| CC-97540 monotherapy | EXPERIMENTAL | Subjects will be assigned to receive CC-97540 followed by 3 consecutive doses of lymphodepleting chemotherapy (fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day). |
| Name | Type | Description |
|---|---|---|
| BMS-986353 | DRUG | Specified dose on specified days |
| Fludarabine | DRUG | Specified dose on specified days |
| Cyclophosphamide | DRUG | Specified dose on specified days |
| Tocilizumab | DRUG | Specified dose on specified days |
| Rituximab | DRUG | Specified dose on specified days |
| Nintedanib | DRUG | Specified dose on specified days |
| Fludarabine Phosphate | DRUG | Specified dose of specified days |
| CC-97540 | DRUG | Specified dose on specified days |
| Lymphodepletion Chemotherapy | DRUG | Intravenous infusion of cyclophosphamide and fludarabine |
Inclusion Criteria \- Participants must fulfill the 2013 American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR) classification criteria for Systemic Sclerosis (SSc), and additionally have the following:. i) Positive Antinuclear Antibodies (ANA) with nucleolar pattern a...
Zolacabtagene autoleucel is an investigational CAR-T cell therapy being developed by Bristol-Myers Squibb Company (BMY) for immunology indications. It is also known as CC-97540, BMS-986353, or Zola-cel. The therapy is being studied in autoimmune and inflammatory conditions including systemic lupus erythematosus, systemic sclerosis, antineutrophil cytoplasmic antibody-associated vasculitis, chronic immune thrombocytopenia, and non-Hodgkin lymphoma.
Zolacabtagene autoleucel is being studied for several autoimmune and immune-mediated conditions, including antineutrophil cytoplasmic antibody-associated vasculitis, chronic immune thrombocytopenia, non-Hodgkin lymphoma, multiple sclerosis, systemic lupus erythematosus, and systemic sclerosis. It is an investigational therapy and has not been approved for any indication.
Zolacabtagene autoleucel is developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY. The company is also known by the alternative designations CC-97540 and BMS-986353 for this asset.
Zolacabtagene autoleucel is in clinical development across Phase 1, Phase 2, and Phase 3 studies. It is an investigational CAR-T therapy and has not been approved by the FDA for any indication. The program includes trials in systemic sclerosis, systemic lupus erythematosus, antineutrophil cytoplasmic antibody-associated vasculitis, and autoimmune cytopenias.
Zolacabtagene autoleucel is being evaluated in several trials, including NCT07603557 in autoimmune cytopenia, NCT07388277 in antineutrophil cytoplasmic antibody-associated vasculitis, NCT07335562 in systemic sclerosis, and NCT07015983 in systemic lupus erythematosus. These studies are being conducted across multiple countries including the United States, Europe, and Japan.
Yes, Zolacabtagene autoleucel is also known as CC-97540 and BMS-986353, and is sometimes referred to as Zola-cel. These are alternative names for the same investigational CAR-T cell therapy developed by Bristol-Myers Squibb Company for autoimmune and inflammatory conditions.