HICARA Application Scope

HICARA® is an autologous CD19-targeted CAR-T cell therapy approved in China for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) after two or more lines of systemic therapy. It includes the following subtypes:

Diffuse large B-cell lymphoma, not otherwise specified (DLBCL-NOS)
Transformed follicular lymphoma (tFL)
High-grade B-cell lymphoma with MYC and BCL2 rearrangements (HGBL)
High-grade B-cell lymphoma, not otherwise specified

HICARA® represents China’s first CAR-T therapy using a stable producer cell line viral vector process, improving batch consistency and reducing production costs.

HICARA Characteristics

Ingredients: Autologous T cells genetically modified with CD19 CAR
Properties: Sterile injectable solution
Packaging Specification: 30 ml × 1 vial/box
Storage: Store frozen at -80°C; protect from light
Expiry Date: As per manufacturer (typically 12 months frozen)
Executive Standard: Complies with national biologics standards
Approval Number: NMPA Class 1 Innovative Biological Product (Approved: 2025/07/30)
Date of Revision: 2025-07-30
Manufacturer: Shanghai Hengrunda Biotech Co., Ltd.

Guidelines for the Use of HICARA

Dosage and Administration:
- Recommended Dose: Individualized, based on lymphodepletion regimen and CAR-T cell count
- Administration: Intravenous infusion following lymphodepleting chemotherapy
- Missed Dose: Not applicable; single administration therapy
Adverse Reactions:
- Common Adverse Reactions: Cytokine release syndrome (CRS), pyrexia, fatigue, nausea
- Serious Adverse Reactions: Severe CRS, neurotoxicity, cytopenias
Contraindications:
- Hypersensitivity to components
- Active uncontrolled infections
Precautions:
- Monitor for CRS and neurotoxicity closely.
- Administer in facilities equipped for intensive care.
- Avoid use in patients with severe cardiac or hepatic impairment.

HICARA Interactions

Concomitant immunosuppressants may reduce CAR-T efficacy.
Avoid live vaccines during and after therapy.
Careful monitoring required with other anticancer therapies

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.