Carteyva Application Scope

Carteyva® is indicated for the treatment of adult patients with the following relapsed or refractory B-cell lymphomas:

Large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
Follicular lymphoma (FL) that is refractory or relapses within 24 months following second-line or higher systemic treatment.
Mantle cell lymphoma (MCL) after two or more lines of systemic therapy, including Bruton tyrosine kinase inhibitors (BTKi

Carteyva Characteristics

Ingredients: Relmacabtagene autoleucel is an autologous anti-CD19 chimeric antigen receptor T (CAR-T) cell immunotherapy product.
Properties: It consists of genetically modified patient-derived T-cells expressing a CAR targeting the CD19 antigen on B-cells (CAR-T therapy).
Packaging Specification: Supplied as a personalized, autologous CAR-T cell infusion—each dose is prepared individually for the patient; there is no standardized vial or tablet packaging.
Storage: Specific storage conditions (e.g., cryopreservation) and handling are managed by the infusion center; not publicly detailed in available sources.
Expiry Date: As an individualized cell therapy product, the “expiry” pertains to cryopreservation viability and institutional handling protocols; not publicly specified.
Executive Standard: Recognized as a Category 1 biologic product upon approval in China—indicative of a biologics-level regulatory standard.
Approval Number: Not specified in publicly available press releases.
Date of Revision: N/A (Such information is typically included in official labels rather than press statements.)
Manufacturer: JW Therapeutics (Shanghai) Co., Ltd., an independent biotechnology company in China that developed the therapy using the Juno Therapeutics CAR-T platform

Dosage and Administration:
- Recommended Dose: Clinical studies administered a single infusion of 100 × 10⁶ CAR-positive T cells following lymphodepletion chemotherapy with fludarabine and cyclophosphamide
- Administration: Intravenous infusion after lymphodepletion.
- Missed Dose: Not specified publicly.
Adverse Reactions:
- Common Adverse Reactions:
  - Cytopenias (neutropenia, leukopenia)
  - Cytokine release syndrome (CRS) of any grade—reported in up to ~47.5% of patients; Grade ≥3 CRS in ~5.1%
  - Neurotoxicity (any grade ~20.3%; ≥Grade 3 in ~3.4%)
- Serious Adverse Reactions: Severe CRS and neurotoxicity (~6.8% each in r/r MCL cohort)
Contraindications: Not publicly detailed. Likely to include uncontrolled infections, prior allo-transplant, severe comorbidities, per typical CAR-T therapy exclusion criteria.
Precautions:
- Manage CRS and neurotoxicity with established protocols (e.g., tocilizumab, steroids).
- Requires administration in experienced centers capable of handling cellular therapies and intensive monitoring. (Standard for CAR-T products.)

Specific drug interactions are not publicly available. Interactions would primarily involve immunosuppressants and pre-medications related to lymphodepletion.

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.