NMPA Approved 2021 · China Only
Carteyva® / Relma‑cel (relmacabtagene autoleucel): Clinical Profile & Patient Journey Guide
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Product Intelligence
1. Product Overview
🌏 First Approved CAR‑T in China — A Milestone for Asian Access
- Carteyva (Relma‑cel) made history as the first CAR‑T therapy approved in China (NMPA, September 2021).
- It significantly expanded access to CAR‑T therapy for patients in China and the broader Asian region.
- This approval marked a critical step forward in making advanced cellular therapies available in emerging healthcare markets.
- It is the first of China's domestically developed CAR‑T products to reach regulatory approval.
| Attribute | Details |
|---|---|
| Brand Name | Carteyva® / Relma‑cel |
| Generic Name | relmacabtagene autoleucel (relma‑cel) |
| Manufacturer | JW Therapeutics (Shanghai, China) |
| Target Antigen | CD19 |
| CAR Construct | CD19 scFv + 4‑1BB costimulatory domain + CD3ζ signaling |
| Unique Feature | First CAR‑T approved in China — NMPA approval September 2021 |
| NMPA Approval | September 2021 |
| FDA / EMA Approval | Not approved |
| Administration | Single intravenous infusion (autologous CAR‑T cells) |
| Manufacturing | Patient's own T‑cells collected via leukapheresis, genetically modified ex vivo using lentiviral vector, expanded, and reinfused |
Carteyva (Relma‑cel) is the first domestically developed CAR‑T therapy approved in China, representing a major milestone for Chinese biotechnology and expanding patient access to CAR‑T in Asia. It uses the same 4‑1BB costimulatory domain as Kymriah and Breyanzi.
Science
2. Mechanism of Action
Carteyva is an autologous CD19‑directed CAR‑T cell therapy structurally similar to Kymriah:
- T‑Cell Collection: Patient's own T‑cells are collected via leukapheresis.
- Genetic Modification: T‑cells are transduced with a lentiviral vector encoding a CAR that recognizes CD19.
- CAR Structure:
- Targeting domain: Single‑chain variable fragment (scFv) derived from anti‑CD19 antibody
- Costimulatory domain: 4‑1BB (same as Kymriah, Breyanzi), which promotes T‑cell persistence and reduces exhaustion
- Signaling domain: CD3ζ, which activates T‑cell cytotoxic function
- Expansion: Modified cells are expanded ex vivo to achieve therapeutic doses.
- Reinfusion: Patient receives lymphodepleting chemotherapy (fludarabine/cyclophosphamide), followed by single infusion of CAR‑T cells.
- Mechanism: CAR‑T cells bind CD19 on B‑cells (normal and malignant), activate cytotoxic response, and persist long‑term due to 4‑1BB signaling.
Key Distinction from Yescarta/Tecartus (CD28 constructs):
- 4‑1BB domain drives more gradual T‑cell activation with longer persistence compared to CD28.
- This results in potentially lower rates of severe CRS and ICANS.
- Carteyva shares the same costimulatory domain as Kymriah and Breyanzi.
Indications
3. Approved Indications
NMPA Approval — September 2021
- Adult patients with relapsed or refractory Diffuse Large B‑Cell Lymphoma (DLBCL) after two or more lines of systemic therapy
- Adult patients with relapsed or refractory Follicular Lymphoma (FL) after two or more lines of systemic therapy
- NMPA label: "For the treatment of adult patients with relapsed or refractory large B‑cell lymphoma and follicular lymphoma after two or more lines of systemic therapy"
Clinical Trial Evidence
- Approval was based on a pivotal Phase II clinical trial conducted in China (relmacabtagene autoleucel in patients with r/r B‑cell non‑Hodgkin lymphoma)
- Demonstrated high overall response rates with durable complete responses
- Safety profile consistent with other 4‑1BB CD19 CAR‑T products
Important Clarification:
- Carteyva is NOT approved by FDA or EMA — currently only available in China.
- It is NOT approved for B‑ALL, MCL, or CLL — only DLBCL and FL.
- Always verify specific indications with the most current prescribing information.
Evidence
4. Clinical Evidence Summary
Pivotal Phase II Trial (China)
- Multicenter, open‑label, single‑arm study
- Adult patients with r/r DLBCL or FL after ≥2 prior lines
- Demonstrated high overall response rates (ORR) with durable complete responses
- Safety profile consistent with other 4‑1BB CD19 CAR‑T products
- Led to NMPA approval in September 2021
- Single‑arm study without control group
Key Observations
- High response rates in Chinese patient population
- Manufacturing success rate >90%
- Long‑term follow‑up data continue to be collected
Key Considerations:
- The pivotal trial was a single‑arm study (no control group).
- Patient populations were highly selected (good performance status, adequate organ function).
- Results may not generalize to all patients in routine clinical practice.
- Long‑term safety and efficacy data continue to be collected through post‑marketing studies.
Safety
5. Safety Profile
Carteyva carries significant safety risks that require careful patient selection and monitoring. The following are based on NMPA prescribing information and clinical trial data:
⚠️ BOXED WARNINGS (NMPA)
Cytokine Release Syndrome (CRS):
- Occurs in majority of patients (typically within first 1‑10 days post‑infusion)
- 4‑1BB construct may be associated with lower severity compared to CD28 constructs
- Symptoms: fever, hypotension, hypoxia, organ dysfunction
- Severe (Grade 3‑4) CRS occurs in approximately 5‑15% of patients
- Management: tocilizumab (IL‑6 receptor antagonist), corticosteroids, supportive care
Neurologic Toxicities (ICANS):
- Immune effector cell‑associated neurotoxicity syndrome (ICANS)
- Symptoms: encephalopathy, aphasia, seizures, cerebral edema
- Typically occurs within first 8 days post‑infusion
- Severe (Grade 3‑4) ICANS occurs in approximately 10‑15% of patients
- Management: corticosteroids, supportive care
Other Serious Adverse Reactions:
- Prolonged cytopenias: Neutropenia, thrombocytopenia, anemia (may persist for weeks to months)
- Infections: Increased risk due to B‑cell aplasia and hypogammaglobulinemia; prophylactic antimicrobials and immunoglobulin replacement may be required
- Hemophagocytic lymphohistiocytosis (HLH) / Macrophage activation syndrome (MAS): Rare but potentially fatal
- Hypogammaglobulinemia: Expected on‑target effect due to B‑cell aplasia; requires monitoring and immunoglobulin replacement
Long‑Term Monitoring:
- Patients must be monitored long‑term for persistent cytopenias, infections, and secondary malignancies
- Annual follow‑up recommended for at least 15 years per NMPA requirement
Regulatory
6. Regulatory Status
| Region | Regulatory Authority | Approval Status | Approval Date |
|---|---|---|---|
| China | NMPA | Approved (DLBCL, FL) | September 2021 |
| United States | FDA | Not approved | — |
| European Union | EMA | Not approved | — |
| United Kingdom | MHRA | Not approved | — |
| Japan | PMDA | Not approved | — |
(Regulatory status may change. Always verify current approval status with regional regulatory authorities.)
Cost & Access
7. Cost & Access Information
Pricing (Approximate, Out‑of‑Pocket for International Patients)
| Country | Approximate Cost (USD) | Notes |
|---|---|---|
| China | $200,000 – $250,000 | Significantly lower than US products; does not include hospitalization, supportive care, or management of complications |
| Other Regions | Not available | Only approved in China; not available internationally |
Significant Cost Advantage:
- Carteyva is priced substantially lower than FDA/EMA approved CD19 CAR‑T products ($200,000‑$250,000 vs $320,000‑$430,000).
- This has made CAR‑T therapy more accessible to patients in China and the broader Asian region.
- However, international patients must consider travel, accommodation, and extended stay costs.
Total Treatment Cost Considerations
- The drug acquisition cost is only one component.
- Additional costs include:
- Leukapheresis and cell collection
- Lymphodepleting chemotherapy
- Hospitalization (typically 2‑4 weeks minimum)
- Management of CRS/ICANS (tocilizumab, corticosteroids, ICU care if needed)
- Long‑term follow‑up and monitoring
- Immunoglobulin replacement therapy
- Total treatment episode cost can exceed $300,000‑$400,000 in China when all components are included.
International Access
- Carteyva is only available in China — not approved in the US, EU, UK, or Japan.
- International patients seeking Carteyva must travel to certified treatment centers in China.
- Our platform can facilitate introductions to certified treatment centers in China, but we cannot guarantee access or coverage.
Compare
8. Comparison with Other CD19 CAR‑T Products
| Feature | Carteyva (relma‑cel) | Kymriah (tisa‑cel) | Yescarta (axi‑cel) | Breyanzi (liso‑cel) |
|---|---|---|---|---|
| Manufacturer | JW Therapeutics | Novartis | Gilead/Kite | BMS |
| Costimulatory Domain | 4‑1BB | 4‑1BB | CD28 | 4‑1BB |
| Approved Region | China (NMPA) | FDA, EMA, NMPA | FDA, EMA, NMPA | FDA, EMA |
| Approved Indications | DLBCL, FL | B‑ALL, DLBCL, FL | LBCL, FL | LBCL, CLL/SLL, FL |
| Approximate Cost (US) | $200,000‑$250,000 | $320,000‑$475,000 | $320,000‑$373,000 | $410,000‑$430,000 |
| Manufacturing Time | 3‑4 weeks | 3‑4 weeks | 3‑4 weeks | 2‑3 weeks |
| FDA Approval Year | Not approved | 2017 (B‑ALL), 2018 (DLBCL) | 2017 (LBCL), 2021 (FL) | 2021 (LBCL), 2024 (CLL/SLL, FL) |
These are general pharmacological differences. Individual patient responses vary. Treatment selection should be based on specific clinical circumstances, disease characteristics, and physician recommendation.
Questions
Frequently Asked Questions
Common questions about Carteyva / Relma‑cel and CAR‑T therapy in China.
What is Carteyva / Relma‑cel and why is it significant? ▾
Carteyva (relmacabtagene autoleucel) is the first CAR‑T therapy approved in China (NMPA, September 2021). It significantly expanded access to CAR‑T therapy for patients in China and the broader Asian region and is priced substantially lower than US/EU products.
Is Carteyva approved by FDA or EMA? ▾
No. Carteyva is currently only approved by the NMPA (China). It is NOT approved by FDA, EMA, MHRA, or PMDA.
What are the approved indications for Carteyva? ▾
Carteyva is approved for adult patients with relapsed or refractory Diffuse Large B‑Cell Lymphoma (DLBCL) and Follicular Lymphoma (FL) after two or more lines of systemic therapy.
How much does Carteyva cost compared to other CAR‑T products? ▾
Carteyva is priced at $200,000‑$250,000 — significantly lower than US products ($320,000‑$430,000) and EU products. However, international patients must factor in travel, accommodation, and extended stay costs in China.
Can I travel to China for Carteyva treatment? ▾
Yes, but Carteyva is only available at certified treatment centers in China. International patients must coordinate with the center for medical records transfer, pre‑treatment evaluation, and the manufacturing process. Plan for at least 2‑3 months away from home including recovery. Our platform can facilitate introductions to certified centers in China.
Medical Disclaimer: CancerCareE is an independent platform for patient information and introduction. It is not a healthcare provider. All medical decisions are made by licensed physicians.
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