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Duvelisib

Phase 1

Recurrent Diffuse Large B-Cell Lymphoma | Small molecule | Oncology |Novartis AG|Last Updated: Jan 20, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment4

FDA Designations

No designations recorded

Clinical trial landscape

Duvelisib · 1 trial · 2 indications

Early Phase 1 1
NCT04890236Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS StudyRecurrent Diffuse Large B-Cell Lymphoma
COMPLETED4 Analytics
EARLY_PHASE1COMPLETED
Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study
Recurrent Diffuse Large B-Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Fold-change increase in CD27/CD28 double positive T cells
From Baseline up to day 15

Will estimate fold-change increase in CD27/CD28 double positive T cells following in vivo exposure to duvelisib using multiparametric flow cytometry.

Secondary Endpoints

Proportion of patients that completed at least 75% of duvelisib doses
Up to day 15
Manufacturing time of CAR-T 19 cells
Up to day 15
Change in proportion of CD27/28 double positive T cells and CD4/8 double negative T cells
At baseline and at day 15
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Treatment (duvelisib)EXPERIMENTALPatients receive duvelisib PO BID for 2 weeks prior to collection of CAR-T cells in the absence of disease progression or unacceptable toxicity. Patients then receive tisagenlecleucel via infusion.

Interventions

NameTypeDescription
DuvelisibDRUGGiven PO
TisagenlecleucelBIOLOGICALGiven via infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Patients must have a biopsy proven diagnosis of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) * Eastern Cooperative Oncology Group (ECOG) \< 2 * Serum creatinine (Cr) \< 2.0 mg/dL * Alanine aminotransferase (AST)/aspartate aminotransferase (ALT) \< 2 x upper limit ...

Countries:United States
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Frequently asked questions about Duvelisib

What is Duvelisib used for in Recurrent Diffuse Large B-Cell Lymphoma?

Duvelisib is being studied for the treatment of recurrent and refractory Diffuse Large B-Cell Lymphoma. It is an investigational small molecule in Phase 1 clinical development. The drug is intended to enhance immune profiles of T cells in patients with this condition.

How does Duvelisib work?

Duvelisib is a small molecule designed to enhance the immune profiles of T cells in patients with recurrent or refractory Diffuse Large B-Cell Lymphoma. The treatment aims to modify T cell function to improve the body's immune response against the cancer.

Who is developing Duvelisib?

Duvelisib is being developed by Novartis AG, a company traded on the stock exchange under the ticker NVS. The drug is currently in Phase 1 clinical development for recurrent Diffuse Large B-Cell Lymphoma.

What phase is Duvelisib in?

Duvelisib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in an early-phase clinical trial for recurrent and refractory Diffuse Large B-Cell Lymphoma.

What clinical trials is Duvelisib in?

Duvelisib is being studied in clinical trial NCT04890236, titled "Duvelisib Exposure to Enhance Immune Profiles of T Cells in Patients With Recurrent or Refractory Diffuse Large B-Cell Lymphoma, DEEP T CELLS Study." This early Phase 1 trial has been completed and enrolled 4 participants in the United States.

Is Duvelisib the same as other drugs?

Duvelisib is a distinct investigational drug being developed by Novartis AG. It is a small molecule intended for use in recurrent Diffuse Large B-Cell Lymphoma. No alternative names for this drug have been established in the clinical development program.