Product Description
A drug used to treat adults with follicular lymphoma or certain types of large B-cell lymphoma that relapsed (came back) or did not get better after treatment with at least two other types of systemic therapy. It is also being studied in the treatment of other types of cancer. Axicabtagene ciloleucel is made using a patientÕs T cells (a type of immune system cell). (Sourced from: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/axicabtagene-ciloleucel)
Mechanisms of Action: CAR-T,CD19
Novel Mechanism: No
Modality: CAR-T
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Bulgaria | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Slovakia | Spain | Sweden | Switzerland | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: FOSTER CITY CA 94404
Company CEO: Daniel P. O’Day
Additional Commercial Interests: Daiichi Sankyo
Clinical Description
Countries in Clinic: Australia, Austria, Belgium, Canada, China, France, Germany, Israel, Italy, Japan, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States, Unknown Location
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Gilead Sciences presented P2 Mantle-Cell Lymphoma results on 2024-12-09 for Axicabtagene ciloleucel
- Clinical Outcomes Reported - Gilead Sciences presented P2 Lymphoma, B-Cell results on 2024-12-08 for Axicabtagene ciloleucel
- Clinical Outcomes Reported - Gilead Sciences presented P2 Lymphoma, B-Cell results on 2024-06-14 for Axicabtagene ciloleucel
Highest Development Phases
Phase 3: Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|Lymphoma, B-Cell
Phase 2: B-Cell Marginal Zone Lymphoma|Cytokine Release Syndrome|Disorders of Sex Development|Lymphoma, Non-Hodgkin|Marginal Zone Lymphoma|Oncology Hematological Unspecified
Phase 1: Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| IRB-68723 | P1 |
Recruiting |
Lymphoma, Non-Hodgkin|Lymphoma, B-Cell |
2038-04-01 |
2023-07-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
| NCT04608487 | P1 |
Active, not recruiting |
Lymphoma |
2025-06-30 |
23% |
2025-01-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| KT-US-982-5968 | P2 |
Recruiting |
Disorders of Sex Development |
2038-09-20 |
2025-05-02 |
Treatments |
|
| 2019-002291-13 | P2 |
Completed |
Lymphoma, B-Cell |
2037-02-07 |
32% |
2025-05-06 |
Treatments|Trial Status |
| jRCT2013230062 | P2 |
Not yet recruiting |
Oncology Hematological Unspecified |
2033-10-31 |
|||
| ZUMA-1 | P2 |
Active, not recruiting |
Diffuse Large B-Cell Lymphoma|Follicular Lymphoma |
2031-12-15 |
49% |
2022-03-13 |
Treatments |
| 2024-512835-53-00 | P2 |
Recruiting |
Diffuse Large B-Cell Lymphoma |
2031-10-15 |
2025-05-02 |
Treatments |
|
| PRIME-CAR | P2 |
Recruiting |
Lymphoma, B-Cell |
2028-10-01 |
12% |
2025-04-05 |
|
| NCI-2024-00209 | P2 |
Recruiting |
Lymphoma, B-Cell |
2027-01-31 |
12% |
2025-01-18 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| NCT06550141 | P2 |
Recruiting |
Follicular Lymphoma|Diffuse Large B-Cell Lymphoma|Lymphoma, Non-Hodgkin |
2026-08-01 |
12% |
2024-12-20 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| RG1006269 | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma |
2026-03-01 |
12% |
2024-11-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| MCC-22113 | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Lymphoma, B-Cell |
2025-11-01 |
12% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| MCC-21892 | P2 |
Recruiting |
Diffuse Large B-Cell Lymphoma |
2025-06-01 |
12% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| ZUMA-5 | P2 |
Completed |
Follicular Lymphoma|B-Cell Marginal Zone Lymphoma|Lymphoma, Non-Hodgkin |
2024-12-05 |
54% |
2025-01-07 |
|
| KTE-C19-105 | P2 |
Completed |
Marginal Zone Lymphoma|Lymphoma, Non-Hodgkin|Follicular Lymphoma |
2024-10-03 |
2025-05-02 |
Treatments |
|
| ZUMA-24 | P2 |
Active, not recruiting |
Lymphoma, B-Cell |
2024-09-20 |
36% |
2024-10-05 |
Primary Completion Date|Primary Endpoints|Treatments |
| NCT04150913 | P2 |
Completed |
Cytokine Release Syndrome|Lymphoma, Non-Hodgkin |
2023-10-30 |
12% |
2025-05-06 |
Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| ZUMA-12 | P2 |
Completed |
Lymphoma, B-Cell |
2023-10-12 |
32% |
2024-12-05 |
Primary Completion Date|Primary Endpoints|Treatments |
| ZUMA-23 | P3 |
Recruiting |
Lymphoma, B-Cell |
2031-03-01 |
91% |
2024-11-27 |
Primary Endpoints|Treatments |
| KT-US-473-0133 | P3 |
Active, not recruiting |
Follicular Lymphoma |
2030-10-31 |
2025-05-02 |
Treatments |
|
| ZUMA-22 | P3 |
Active, not recruiting |
Follicular Lymphoma |
2030-10-01 |
93% |
2025-05-10 |
Primary Endpoints|Treatments|Trial Status |
| jRCT2063230096 | P3 |
Recruiting |
Follicular Lymphoma |
2030-06-30 |
|||
| KT-US-484-0136 | P3 |
Active, not recruiting |
Diffuse Large B-Cell Lymphoma |
2029-12-31 |
91% |
2025-05-02 |
Treatments |
| jRCT2033230370 | P3 |
Not yet recruiting |
Lymphoma, B-Cell|Follicular Lymphoma |
2026-12-31 |
|||
| jRCT2023240034 | P3 |
Not yet recruiting |
Lymphoma, B-Cell |
2024-09-30 |