Overview
Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy, or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immunocellular therapy that involves autologous T cells that are collected from each individual patient and genetically engineered to express a specific protein called a chimeric antigen receptor (CAR) that specifically target CD19 antigens. Modified T cells are infused back into the patient's body. These CD19-directed chimeric antigen receptors (CD19 CAR-T cells) direct the T cells to target and kill leukemia cells that express CD19 on the cell surface. In a multicenter clinical trial involving pediatric and young adult patients with relapsed or refractory B-cell precursor ALL, the overall remission rate within three months of treatment was 83 percent.
Background
Tisagenlecleucel is a CD19-directed genetically modified autologous T cell immunotherapy, or a CAR-T cell therapy for B-cell acute lymphoblastic leukemia. It was granted approval by FDA in August 2017 under the market name Kymriah. Tisagenlecleucel is an immunocellular therapy that involves autologous T cells that are collected from each individual patient and genetically engineered to express a specific protein called a chimeric antigen receptor (CAR) that specifically target CD19 antigens. Modified T cells are infused back into the patient's body. These CD19-directed chimeric antigen receptors (CD19 CAR-T cells) direct the T cells to target and kill leukemia cells that express CD19 on the cell surface. In a multicenter clinical trial involving pediatric and young adult patients with relapsed or refractory B-cell precursor ALL, the overall remission rate within three months of treatment was 83 percent.
Indication
Tisagenlecleucel is indicated for use in individuals aged 25 years and younger with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. It is also used to treat adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Tisagenlecleucel is also indicated in adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Associated Conditions
- Refractory Diffuse Large B Cell Lymphoma (DLBCL)
- Refractory Follicular Lymphoma
- Relapsed Diffuse Large B-cell Lymphoma (DLBCL)
- Relapsed Follicular Lymphoma
- Refractory B-cell precursor acute lymphoblastic leukemia
- Relapsed B cell precursor Acute lymphoblastic leukemia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/21 | Phase 1 | Recruiting | |||
2024/05/10 | Phase 1 | Recruiting | |||
2023/06/05 | Phase 3 | Recruiting | |||
2022/12/01 | Phase 2 | Recruiting | |||
2022/07/15 | Phase 2 | Active, not recruiting | |||
2021/10/13 | Phase 1 | Recruiting | NeoImmuneTech | ||
2021/05/18 | Early Phase 1 | Completed | |||
2021/04/22 | Phase 1 | Recruiting | |||
2019/11/13 | Phase 2 | Terminated | |||
2019/10/22 | Phase 1 | Active, not recruiting | Matthew J. Frigault, M.D. |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/23/2018 | ||
Authorised | 8/23/2018 | ||
Authorised | 8/23/2018 | ||
Authorised | 8/23/2018 | ||
Authorised | 8/23/2018 | ||
Authorised | 8/23/2018 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| Δ KYMRIAH DISPERSION FOR INFUSION | N/A | N/A | N/A | 3/5/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah | 475975 | Biological | A | 1/16/2025 | |
| T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah | 312685 | Biological | A | 12/19/2018 | |
| T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah | 475976 | Biological | A | 1/16/2025 | |
| T Cells - Tisagenlecleucel, cryopreserved - T - Kymriah | 312686 | Biological | A | 12/19/2018 |