> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/zolacabtagene-autoleucel-f6edac71-5d03-42c4-8eca-c1704ba6b4fb
> Record changed: 2026-10-13

# Zolacabtagene autoleucel

Highest phase reached

Phase 1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068475)

Drug type

Gene

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068475)

## Development status

**Listing at source**

Listed

**Highest phase reached**

Phase 1

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068475)

## Names and chemistry

**Drug type**

Gene

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068475)

**Drug name**

Zolacabtagene autoleucel

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068475)

### Other names (13)

- bms 986353
- bms 986353 is an investigational cd19 targeted car t cell product the cd19 specific car consists of a single chain variable fragment scfv binding domain derived from a cd19 specific monoclonal antibody mab fmc63 an igg derived hinge region a cd28 transmembrane domain and the cd137 41bb and cd3ζ chain signaling domains the third generation sin lentiviral vector which encodes the car domains described above also encodes a truncated human epidermal growth factor receptor egfrt that is expressed separately from the cd19 car on the t cell surface
- BMS-986353
- BMS-986353 is an investigational CD19-targeted CAR T-cell product. The CD19-specific CAR consists of a single-chain variable fragment (scFv) binding domain derived from a CD19-specific monoclonal antibody (mAb; FMC63), an IgG-derived hinge region, a CD28 transmembrane domain, and the CD137 (41BB) and CD3ζ chain signaling domains. The third-generation SIN lentiviral vector, which encodes the CAR domains described above, also encodes a truncated human epidermal growth factor receptor (EGFRt) that is expressed separately from the CD19 CAR on the T cell surface
- cc 97540
- CC 97540 \[WHO-DD\]
- cc 97540 who dd
- CC-97540
- CC-97540 (BMS-986353)
- zolacabtagene autoleucel
- Zolacabtagene autoleucel
- ZOLACABTAGENE AUTOLEUCEL \[USAN\]
- zolacabtagene autoleucel usan

## Identifiers

**ChEMBL ID**

CHEMBL6068475

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL6068475)

**FDA ingredient codes (UNII)**

- DU963TX85S

## Regulatory information

### Other regulatory facts

**First in class**

No

**Orphan designation**

No

## Pharmacology

### Investigated indications (5)

- **Condition**  
Leukemia, B-Cell

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000094

**Subject identifier**  
D015448
- **Condition**  
Lymphoma, Follicular

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0000096

**Subject identifier**  
D008224
- **Condition**  
Lymphoma, Non-Hodgkin

**Highest recorded phase**  
1

**Condition identifier**  
EFO:0005952

**Subject identifier**  
D008228
- **Condition**  
Multiple Sclerosis

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0005301

**Subject identifier**  
D009103
- **Condition**  
Lupus Erythematosus, Systemic

**Highest recorded phase**  
1

**Condition identifier**  
MONDO:0007915

**Subject identifier**  
D008180

### Open Targets indications (16)

- **Condition identifier**  
EFO\_0000094
- **Condition identifier**  
EFO\_0005952

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0004947
- **Condition identifier**  
MONDO\_0005100

**Highest recorded phase**  
3
- **Condition identifier**  
MONDO\_0005301

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0005556

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0007915
- **Condition identifier**  
MONDO\_0007915

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0008383

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0008558

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0009688

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0015492

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0018908

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0019100

**Highest recorded phase**  
1
- **Condition identifier**  
MONDO\_0020108

**Highest recorded phase**  
2
- **Condition identifier**  
MONDO\_0600023

**Highest recorded phase**  
1

### Trial references (2)

- NCT04231747  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04231747)
- NCT06220201  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06220201)

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

## Related records

### Trials (8)

- A Safety and Tolerability Study of CC- 97540 (BMS-086353) in Anti-Aquaporin 4 Antibody Positive Neuromyelitis Optica Patients
- A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
- [A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)](https://trialight.com/data/trial/a-study-of-cc-97540-cd-19-targeted-nex-t-car-t-cells-in-8290d9b7-24da-4ac1-a5b0-156c725633bb.md)
- A Study of CC-97540, CD19-targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
- A Study to Compare the Efficacy and Safety of BMS-986353 (Zolacabtagene- Autoleucel / Zola-cel), CD19-CAR T Cells, Versus Standard of Care in Participants With Active Systemic Sclerosis
- A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
- CC-97540 in Patients With Antineutrophil Cytoplasmic Antibody-associated Vasculitis
- Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)

### In development for (5)

- B-cell acute lymphoblastic leukemia Phase 1
- [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 1
- Neoplasm of mature B-cells Phase 1
- [Non-Hodgkin lymphoma](https://trialight.com/data/condition/non-hodgkin-lymphoma-9fc07e31-fd30-5055-991f-04d10cc1f646.md) Phase 1
- [Systemic lupus erythematosus](https://trialight.com/data/condition/systemic-lupus-erythematosus-6c9d074f-cc5f-588b-bf0c-6338d30c6eac.md) Phase 1

---

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