Tisagenlecleucel

Phase 3Cell therapy

Tisagenlecleucel is a cell therapy that works as a CD19 CAR-T.[2] It is being investigated across 4 indications, with its most advanced program in Phase 3.[1]

Tisagenlecleucel is one of 98 cell therapy programs targeting Leukemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

LeukemiaRecruiting

CAR-TSuspended

B-Cell Acute Lymphoblastic LeukemiaActive, not recruiting

Follicular LymphomaActive, not recruiting

LeukemiaPhase 1

Recruiting

CAR-TPreclinical

Suspended

B-Cell Acute Lymphoblastic LeukemiaPhase 2

Active, not recruiting

Follicular LymphomaPhase 3

Active, not recruiting

Competition

Competitive Landscape

108 competitors in Leukemia

#DrugCompanyPhaseTrials

Cytosar

Teva

Phase 3

53 2

Trexall

Jazz Pharmaceuticals

Phase 3

30 3

Fludara

Sanofi

Phase 3

20 4

Cytoxan

BBaxter Healthcare Corporation

Phase 3

56 5

Rituxan

Roche

Phase 3

16 6

Adriamycin

Pfizer

Phase 3

11 7

Oncovin

Eli Lilly

Phase 3

10 8

Vepesid

AAvyxa

Phase 3

23 9

Decadron

AAspen Global Incorporated

Phase 3

23 10

Mesnex

BBaxter Healthcare Corporation

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Leukemia

NCT06408194

Q3 2027

Phase 2Active, not recruiting

B-Cell Acute Lymphoblastic Leukemia

NCT05460533

Q4 2027

Phase 1Recruiting

Recurrent Diffuse Large B-Cell Lymphoma

NCT07676877

Q2 2030

Phase 2Recruiting

Diffuse Large B-Cell Lymphoma

NCT05633615

Clinical

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma4 trials

Study of Tisagenlecleucel in Combination With Ibrutinib in r/r Diffuse Large B-cell Lymphoma Patients

Terminated· Novartis logo

Novartis·Phase 1·NCT03876028·10 enrolled

Study of Tisagenlecleucel in Combination With Pembrolizumab in r/r Diffuse Large B-cell Lymphoma Patients

Completed· Novartis logo

Novartis·Phase 1·NCT03630159·12 enrolled

Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study

Completed·EEmory University·Phase 1·NCT04890236·4 enrolled

Show 1 more trial

A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment for Relapsed/Refractory Diffuse Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma

Recruiting·SSWOG Cancer Research Network·Phase 2·NCT05633615·396 enrolled

Lymphoma3 trials

Tisagenlecleucel In Primary CNS Lymphoma

Completed·—·Phase 1·NCT04134117·13 enrolled

Phase II Open Label Trial to Determine Safety & Efficacy of Tisagenlecleucel in Pediatric Non-Hodgkin Lymphoma Patients

Completed· Novartis logo

Novartis·Phase 2·NCT03610724·34 enrolled

Study of Tisagenlecleucel in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-cell Non-Hodgkin Lymphoma (DLBCL)

Withdrawn· Novartis logo

Novartis·Phase 2·NCT04456023

Acute Lymphoblastic Leukemia2 trials

Tisagenlecleucel vs Blinatumomab or Inotuzumab for Patients With Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Withdrawn· Novartis logo

Novartis·Phase 3·NCT03628053

Study of Efficacy and Safety of Reinfusion of Tisagenlecleucel in Pediatric and Young Adult Patients With Acute Lymphoblastic Leukemia (ALL)

Terminated· Novartis logo

Novartis·Phase 2·NCT04225676·5 enrolled

Follicular Lymphoma2 trials

A Phase III Trial Comparing Tisagenlecleucel to Standard of Care (SoC) in Adult Participants With r/r Follicular Lymphoma

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05888493·109 enrolled

A Phase II, Single Arm, Multicenter Open Label Trial to Determine the Efficacy and Safety of Tisagenlecleucel (CTL019) in Adult Patients With Refractory or Relapsed Follicular Lymphoma

Completed· Novartis logo

Novartis·Phase 2·NCT03568461·98 enrolled

B-cell acute lymphoblastic leukemia1 trial

A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL)

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05460533·30 enrolled

7 more indications

Relapsed or Refractory1 trial

Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL

Withdrawn· Novartis logo

Novartis·Phase 2·NCT04156659

Efficacy and Safety1 trial

Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients

Completed· Novartis logo

Novartis·Phase 2·NCT02445248·115 enrolled

Lymphoid Malignancies1 trial

CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT02529813·26 enrolled

DLBCL1 trial

Phase I/II Trial Using E7777 to Enhance Regulatory T-Cell Depletion Prior to CAR-T Therapy for Relapsed/Refractory Large B-Cell Lymphomas

Suspended·MMasonic Cancer Center, University of Minnesota·Preclinical·NCT04855253·30 enrolled

Recurrent Diffuse Large B-Cell Lymphoma1 trial

A Phase I Trial of Lymphodepletion Intensification With Low Dose Total Body Irradiation With Dose Expansion for Standard-of-Care Tisagenlecleucel in Patients With Large B-Cell Lymphoma

Recruiting·NNathan Denlinger·Phase 1·NCT07676877·18 enrolled

Leukemia1 trial

Phase I/Ib Clinical Trial of Autologous CD22 Chimeric Antigen Receptor (CAR) T Cells Following Commercial CD19 CAR T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

Recruiting·SStanford University·Phase 1·NCT06408194·28 enrolled

Refractory Diffuse Large B-Cell Lymphoma1 trial

A Phase 1b Study Evaluating the Safety, Tolerability and Preliminary Anti-tumor Activity of NT-I7 a Long-acting Human IL-7, Post-Kymriah®, Post-Yescarta®, or Post-Breyanzi® in Subjects With Relapsed/Refractory Large B-cell Lymphoma

Completed·NNeoImmuneTech·Phase 1·NCT05075603·17 enrolled

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Tisagenlecleucel. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tisagenlecleucel compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tisagenlecleucel. EMBL-EBI & Wellcome Sanger Institute.
[4]
PubMed — 1 publication indexed for Tisagenlecleucel. U.S. National Library of Medicine.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: CD19 CAR-T[2]
Modality: Cell therapy[2]
Highest Phase: Phase 3[1]
Company: Novartis

Key Publications[4]

Tisagenlecleucel in Pediatric ALL: ELIANA 5-Year Follow-Up

N Engl J MedApr 20, 2023DOI: 10.1056/NEJMoa2215561

Tisagenlecleucel

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Q4 2027

Q2 2030

Trials by Indication[1]

Diffuse Large B-Cell Lymphoma4 trials

Lymphoma3 trials

Acute Lymphoblastic Leukemia2 trials

Follicular Lymphoma2 trials

B-cell acute lymphoblastic leukemia1 trial

Relapsed or Refractory1 trial

Efficacy and Safety1 trial

Lymphoid Malignancies1 trial

DLBCL1 trial

Recurrent Diffuse Large B-Cell Lymphoma1 trial

Leukemia1 trial

Refractory Diffuse Large B-Cell Lymphoma1 trial

References

Drug Info

Quick Facts

Key Publications[4]

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