A study for patients with aggressive B-cell non-Hodgkin lymphoma.

Trial ID:
IRB-24-8371
James Mason, M.D.

Inclusion Criteria

Patients must:

  • Be age 18 years or older.
    Have histologically confirmed aggressive non-Hodgkin lymphoma (NHL
    Have received at least one prior line of therapy.
    Have relapsed or refractory disease (disease progression after the last treatment regimen)
    Have at least one measurable lesion.
    Have an ECOG performance status of 0 or 1.
    Have appropriate lab parameters.
    Have a negative serum or urine pregnancy test (women only).
    Be willing and able to practice birth control from the time of consent through 1 year after the last dose of study drug (all patients)
    Be willing and able to undergo at least one leukapheresis procedure.
    Be willing and able to remain within 60 minutes of travel time to the study site until 28 days after the time of IMPT-314 infusion.

Exclusion Criteria

Patients must not:

  • Have a history of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast) unless disease-free for at least 3 years.
    Have active central nervous system (CNS) involvement by malignancy seen on MRI or by lumbar puncture.
    Have a history of cardiac lymphoma involvement.
    Have received any systemic inhibitory/stimulatory immune checkpoint molecule therapy in the specified time frame before enrollment
    Have received radiation therapy within 3 weeks before enrollment.
    Have a history of allogeneic stem cell or solid organ transplantation.
    Have received an autologous stem cell transplantation within 6 weeks before enrollment.
    Have a history of prior CAR T cell therapy other than YESCARTA®, KYMRIAH®, or BREYANZI®.
    Have any immunodeficiency or history of autoimmune disease
    Have a presence of fungal, bacterial, viral, or other infection that is uncontrolled or requires intravenous (IV) antimicrobials for management.
    Have

Additional Info

* A bone marrow aspirate and biopsy are required during the workup for this study.

* All treatments and physician visits during this study will occur at Scripps Clinic Torrey Pines (Geisel Pavilion) or the Scripps Green Hospital.

* Treatment and observation will be conducted in-patient. You will remain in the hospital for at least 7 days until discharged by the study doctor.

* Search NCT05826535 at https://clinicaltrials.gov website for more information.

Contact Info:

  • Clinical Research Services
  • CRSLeadership@scrippshealth.org