Health Trials

ST-067 in Combination With CD19-Directed CAR T-Cell Therapy (Liso-cel) in Relapsed/Refractory Large B-Cell Lymphoma

ConditionsRecurrent Diffuse Large B-Cell LymphomaRecurrent Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRecurrent Grade 3b Follicular LymphomaRecurrent High-Grade B-Cell LymphomaRecurrent Indolent B-Cell Non-Hodgkin LymphomaRecurrent Primary Mediastinal Large B-Cell LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedRefractory Grade 3b Follicular LymphomaRefractory High-Grade B-Cell LymphomaRefractory Indolent B-Cell Non-Hodgkin LymphomaRefractory Primary Mediastinal Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFred Hutchinson Cancer Center

About this trial

This phase I/II trial tests the safety, side effects, and best dose/regimen of ST-067 in combination with CD19-directed chimeric antigen receptor (CAR) T-cell therapy (liso-cel) and how well it works in treating patients with large B-cell lymphoma (LBCL) that has come back after a period of improvement (recurrent) or LBCL that has not responded to previous treatment (refractory). ST-067 is an engineered variant of the human cytokine interleukin-18 that may help the immune system kill cancer cells. Lisocabtagene maraleucel (liso-cel) is an autologous CAR T-cell therapy prepared using the person's own immune system (a group of cells, tissues, and organs that protect the body from attack by bacteria, viruses, and cancer cells) to fight the cancer. Giving ST-067 in combination with liso-cel may better treat patients with relapsed/refractory LBCL.

Eligibility criteria

Qualifiers

Male or female >= 18 years of age at the time of consent

Patients with LBCL (including diffuse large B-cell lymphoma [DLBCL] not otherwise specified [including DLBCL arising from indolent lymphoma], high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B) with at least 2 lines of systemic therapy and an Food and Drug Administration (FDA)-approved indication for treatment with liso-cel

Fluorodeoxyglucose (FDG)-avid disease on PET imaging before lymphodepletion or pathology evidence of active disease

Evidence of CD19 expression on any prior or current tumor specimen or a high likelihood of CD19 expression based on disease histology

Disqualifiers

Planned use of out-of-specification liso-cel product

Adequately treated basal cell or squamous cell carcinoma of the skin.

In situ prostate, ductal breast carcinoma breast, and cervical carcinoma.

Adequately treated papillary, noninvasive bladder cancer.

Trial design

Treatments tested in this trial

  • Vevoctadekin
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Echocardiography Test
  • Leukapheresis
  • Lisocabtagene Maraleucel
  • Lumbar Puncture
  • Lymphodepletion Therapy
  • Multigated Acquisition Scan
  • Positron Emission Tomography
  • X-Ray Imaging
  • Biospecimen Collection

Treatment groups

33 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

Simcha Therapeutics

Collaborator

Source ClinicalTrials.gov