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

NCT04890236 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-01-20

No results posted yet for this study

Summary

This early phase I trial investigates how well duvelisib exposure before CAR-T cell manufacturing works to enhance immune profiles of T cells in patients with diffuse large B-cell lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Duvelisib, an oral phosphoinositide 3-kinase (PI3K) inhibitor, may favorably change a patient's T cells to make them more efficient and have a longer duration for manufacturing of CAR-T cells.

Conditions

  • Recurrent Diffuse Large B-Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma

Interventions

DRUG

Duvelisib

Given PO

BIOLOGICAL

Tisagenlecleucel

Given via infusion

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Secura Bio, Inc.

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Edmund K Waller, MD, PhD · Emory University Hospital/Winship Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2024-03-20
Completion
2024-09-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890236 on ClinicalTrials.gov