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