Drugs / Tisagenlecleucel
Tisagenlecleucel
also known as
CART-19 · CTL019 · allo-CART-19 · CAR-T19/CAR-T22 · CART-19 and 20 cells · CART-19/22 · huCART-19 · KYMRIAH · +1 more
Cell therapy targets CD19 via depletion
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Kymriah | — | 2018-08-23 | europa.eu ↗ |
Trials 51 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05075603 Background | Aug 2021 → Dec 2024 | high grade B-cell lymphoma | NeoImmuneTech | Completed | No outcome recorded |
| Phase 1 | NCT02906371 Comparator | Aug 2016 → Mar 2020 | B-cell childhood acute lymphoblastic leukemia | University of Pennsylvania | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04855253 Background | Jun 2021 → Sep 2026 | high grade B-cell lymphoma | Masonic Cancer Center, University of Minnesota | Suspended | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT05633615 Background | Jun 2023 → Jun 2030 expected | primary mediastinal large B-cell lymphoma | SWOG Cancer Research Network | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05020392 Comparator | Sep 2021 → Oct 2023 | B-cell chronic lymphocytic leukemia, Burkitt lymphoma, diffuse large B-cell lymphoma, follicular lymphoma +1 | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Unknown | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03601442 Background | — | leukemia, lymphoma | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 32 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-06-12 | Novartis Pharmaceuticals | Novartis five-year Kymriah® data show durable remission and long-term survival maintained in children and young adults with advanced B-cell ALL novartis.com ↗ |
| 2022-05-28 | Novartis Pharmaceuticals | FDA approves Novartis Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma novartis.com ↗ |
| 2022-05-04 | Novartis Pharmaceuticals | Novartis Kymriah® receives EC approval as first CAR-T cell therapy for adults with relapsed or refractory follicular lymphoma novartis.com ↗ |
| 2022-03-25 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe novartis.com ↗ |
| 2021-12-11 | Novartis Pharmaceuticals | Novartis Kymriah® demonstrates strong responses in high-risk patients with relapsed or refractory follicular lymphoma in extended study follow-up novartis.com ↗ |
| 2021-10-27 | Novartis Pharmaceuticals | Novartis receives priority review by US FDA and filing acceptance by EMA for Kymriah® to treat patients with relapsed or refractory follicular lymphoma novartis.com ↗ |
| 2021-08-24 | Novartis Pharmaceuticals | Novartis provides update on BELINDA study investigating Kymriah® as second-line treatment in aggressive B-cell non-Hodgkin lymphoma novartis.com ↗ |
| 2021-06-02 | Novartis Pharmaceuticals | Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma novartis.com ↗ |
| 2020-12-05 | Novartis Pharmaceuticals | Novartis analyses confirm benefit of Kymriah® with clinically meaningful rates of complete response seen in patients with certain advanced lymphomas novartis.com ↗ |
| 2020-10-30 | Novartis Pharmaceuticals | Novartis expands Kymriah® manufacturing footprint with first-ever approved site for commercial CAR-T cell therapy manufacturing in Asia novartis.com ↗ |
| 2020-08-04 | Novartis Pharmaceuticals | Novartis announces Kymriah® meets primary endpoint at interim analysis of pivotal study in follicular lymphoma novartis.com ↗ |
| 2020-04-22 | Novartis Pharmaceuticals | Novartis Kymriah® receives FDA Regenerative Medicine Advanced Therapy designation in follicular lymphoma novartis.com ↗ |
| 2019-12-09 | Novartis Pharmaceuticals | Novartis Kymriah® demonstrates consistent efficacy and safety outcomes in US patients when used in real-world setting novartis.com ↗ |
| 2018-12-01 | Novartis Pharmaceuticals | Novartis announces longer-term analyses from pivotal Kymriah® trials that showed durable responses are maintained in patients with advanced blood cancers novartis.com ↗ |
| 2018-08-27 | Novartis Pharmaceuticals | Novartis receives European Commission approval of its CAR-T cell therapy, Kymriah® (tisagenlecleucel) novartis.com ↗ |
| 2018-06-29 | Novartis Pharmaceuticals | Novartis receives positive CHMP opinion for Kymriah® for treating two aggressive blood cancers, marking important medical advance for patients in Europe novartis.com ↗ |
| 2018-06-16 | Novartis Pharmaceuticals | Novartis JULIET trial of Kymriah demonstrates more than one-year durability of responses in adults with relapsed or refractory DLBCL novartis.com ↗ |
| 2018-05-01 | Novartis Pharmaceuticals | Kymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma novartis.com ↗ |
| 2018-01-31 | Novartis Pharmaceuticals | Novartis announces NEJM publication of updated analysis from ELIANA trial showing longer-term durable remissions with Kymriah(TM) in children, young adults with r/r ALL novartis.com ↗ |
| 2018-01-17 | Novartis Pharmaceuticals | Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL novartis.com ↗ |
| 2017-12-10 | Novartis Pharmaceuticals | Primary analysis results from Novartis pivotal JULIET trial show Kymriah(TM) (tisagenlecleucel) sustained complete responses at six months in adults with r/r DLBCL, a difficult-to-treat cancer novartis.com ↗ |
| 2017-11-06 | Novartis Pharmaceuticals | Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA* to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL novartis.com ↗ |
| 2017-10-31 | Novartis Pharmaceuticals | Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy novartis.com ↗ |
| 2017-08-30 | Novartis Pharmaceuticals | Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice novartis.com ↗ |
| 2017-07-12 | Novartis Pharmaceuticals | Novartis CAR-T cell therapy CTL019 unanimously (10-0) recommended for approval by FDA advisory committee to treat pediatric, young adult r/r B-cell ALL novartis.com ↗ |
| 2017-06-23 | Novartis Pharmaceuticals | Novartis pivotal CTL019 6-month follow-up data show durable remission rates in children, young adults with r/r B-cell ALL novartis.com ↗ |
| 2017-06-07 | Novartis Pharmaceuticals | Novartis interim results from global, pivotal CTL019 trial show durable complete responses in adults with r/r DLBCL novartis.com ↗ |
| 2017-04-18 | Novartis Pharmaceuticals | Novartis CAR-T cell therapy CTL019 receives FDA Breakthrough Therapy designation for treatment of adult patients with r/r DLBCL novartis.com ↗ |
| 2016-12-04 | Novartis Pharmaceuticals | Novartis presents results from first global registration trial of CTL019 in pediatric and young adult patients with r/r B-ALL novartis.com ↗ |
| 2015-12-07 | Novartis Pharmaceuticals | Novartis highlights new CTL019 Phase II data demonstrating 93% complete remission in pediatric patients with r/r ALL novartis.com ↗ |
| 2015-12-06 | Novartis Pharmaceuticals | Novartis announces new CTL019 study data demonstrating overall response in adult patients with certain types of lymphoma novartis.com ↗ |
| 2015-06-01 | Novartis Pharmaceuticals | Novartis highlights CTL019 data showing its potential in the treatment of specific types of hard-to-treat non-Hodgkin lymphoma novartis.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 64 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tisagenlecleucel | “We evaluated long-term outcomes in 38 patients with relapsed or refractory B-cell non-Hodgkin lymphomas (24 patients with large B-cell lymphoma and 14 with follicular lymphoma)...” PMID 42341302 ↗ Jun 202626“This trial evaluates the CMR rate 12 weeks after tisagenlecleucel (CTL019) infusion, the incidence and severity of adverse events, progression-free survival, and overall...” NCT04161118 ↗ “Tisagenlecleucel, an anti-CD19 chimeric antigen receptor T cell therapy, has demonstrated efficacy in children and young adults with relapsed/refractory B cell acute...” PMID 34353848 ↗ Aug 2021 “The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (CTL019) has an 81% response rate in children with relapsed or chemotherapy refractory (r/r) B-cell...” PMID 31815579 ↗ Dec 2019 “A phase II trial of TisaGenlecleucel (CTL019) in Elderly Patients with First-Relapsed or Primary Refractory Aggressive B-cell Non-Hodgkin Lymphoma” NCT04161118 ↗ “Pediatric patients with relapsed or refractory B-cell ALL who were treated with single dose of tisagenlecleucel (CTL019).” NCT02435849 ↗ |
| Known as | allo-CART-19 | “At dosing, patients will receive redirected donor lymphocytes targeted against CD19 (allo-CART-19 cells).” NCT01551043 ↗ |
| Known as | CAR-T19/CAR-T22 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04204161 ↗ |
| Known as | CART-19 | “The target dose range administered in this study is 1-5x108 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x107 CART19), 30% on Day 1 (3x107-1.5x108 CART19), 60%...” NCT02640209 ↗24“CD19-targeted chimeric antigen receptor-T cell (CART19) therapy is clinically effective in patients with relapsed or refractory B-cell lymphoma (BCL)” PMID 41123227 ↗ Oct 2025 “A prospective study to evaluate the safety and efficacy of CART19 for refractory/relapsed B cell lymphoma.” NCT03118180 ↗ “CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB” NCT02935543 ↗ “combination therapy with CART-meso cells and CART19 cells” NCT02465983 ↗ “CART19 (CTL019) associated cytokine release syndrome” NCT02906371 ↗ |
| Known as | CART-19 and 20 cells | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06160362 ↗ |
| Known as | CART-19/22 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03614858 ↗ |
| Known as | CTL019 | “monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for...” NCT02445222 ↗12“We found that ≥5 cycles of ibrutinib therapy improved the expansion of CD19-directed CAR T cells (CTL019), in association with decreased expression of the immunosuppressive...” PMID 26813675 ↗ Jan 2016 “This trial evaluates the CMR rate 12 weeks after tisagenlecleucel (CTL019) infusion, the incidence and severity of adverse events, progression-free survival, and overall...” NCT04161118 ↗ “The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (CTL019) has an 81% response rate in children with relapsed or chemotherapy refractory (r/r) B-cell...” PMID 31815579 ↗ Dec 2019 “We used autologous T cells that express a CD19-directed CAR (CTL019) to treat patients with diffuse large B-cell lymphoma or follicular lymphoma that had relapsed or was...” PMID 29226764 ↗ Dec 2017 “CART19 (CTL019) associated cytokine release syndrome” NCT02906371 ↗ |
| Known as | huCART-19 | “Preclinical data suggesting synergy between CART-19 and the Bruton's tyrosine kinase (BTK) inhibitor ibrutinib prompted us to conduct a prospective single-center phase 2 trial...” PMID 35349631 ↗ Nov 2022 |
| Known as | KYMRIAH | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03642626 ↗ |
| Known as | tisa-cel | “The ELARA trial indicates tisagenlecleucel (tisa-cel) is an effective anti-CD19” PMID 35973192 ↗ Nov 2022 |
| Action | Deplete | “Chimeric antigen receptor-modified T-cell therapy against CD19 was effective in treating relapsed and refractory ALL.” PMID 25317870 ↗ Oct 2014 |
| Modality | Cell therapy | “The anti-CD19 chimeric antigen receptor T-cell therapy tisagenlecleucel (CTL019)” PMID 31815579 ↗ Dec 2019 |
| Route | Intravenous | “administered as an IV infusion” NCT01029366 ↗ |
| Target | CD19 | “Chimeric antigen receptor-modified T cells targeting CD19 may overcome many limitations of conventional therapies and induce remission in patients with refractory disease.” PMID 25317870 ↗ Oct 2014 |