Duvelisib After CAR T-Cell Therapy for Lymphoma
Trial Summary
What is the purpose of this trial?
While chimeric antigen receptor T-cell (CAR T-cell) therapy produces impressive response rates in heavily pre-treated patients, early loss of response remains a barrier. One potential mechanism of relapse is limited CAR T-cell persistence. Pre-clinical research shows that PI3K inhibition represents an intriguing mechanism for increasing CAR T-cell persistence that is easily reversible and CAR T-cell agnostic. The investigators hypothesize that PI3K inhibition with duvelisib would be safe, may provide effective prophylaxis against cytokine release syndrome (CRS), and may enhance the persistence and efficacy of CAR T-cells in the treatment of hematologic malignancies.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A inducers or inhibitors before starting duvelisib. If you're on such medications, you'll need to discontinue them 7 days before starting duvelisib for inhibitors, 14 days for inducers, or wait for 4-5 half-lives of the drug.
Is Duvelisib safe for use in humans?
Duvelisib, also known as Copiktra, IPI-145, or INK-1197, has been studied for safety in humans. It is generally considered safe, but like many treatments, it can have side effects. Common side effects include diarrhea, low white blood cell counts, and liver enzyme changes, which are usually manageable with medical supervision.12345
How does the drug Duvelisib differ from other treatments for lymphoma after CAR T-cell therapy?
Duvelisib is unique because it is a targeted therapy that inhibits specific enzymes (PI3K-delta and PI3K-gamma) involved in the growth and survival of cancer cells, offering a different mechanism of action compared to traditional chemotherapy or CAR T-cell therapy. This makes it a potential option for patients who have not responded to or have relapsed after CAR T-cell therapy.45678
Research Team
Armin Ghobadi, M.D.
Principal Investigator
Washington University School of Medicine
Eligibility Criteria
This trial is for adults over 18 with certain types of non-Hodgkin lymphoma eligible for CAR T-cell therapy, not B-cell acute lymphoblastic leukemia. Participants must understand the study and consent to it, use effective contraception, and not be pregnant or breastfeeding. They can't have allergies to duvelisib or similar drugs, uncontrolled infections, significant heart/kidney/liver disease, other cancers (except some skin cancers), active CNS involvement by malignancy, or be on strong CYP3A inducers/inhibitors.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive duvelisib from Day -2 through Day 28 to determine the maximum tolerated dose
Dose Expansion
Participants in Cohort A receive duvelisib from Day -2 to Day 28, and Cohort B from Day -2 to Day 180 with cycles of dosing and rest
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Duvelisib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
SecuraBio
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
The Foundation for Barnes-Jewish Hospital
Collaborator