NCT03305445

Nivolumab/Ipilimumab-Primed Immunotransplant for DLBCL

A Multi-center Phase Ib/II Trial of Nivolumab/Ipilimumab-Primed Immunotransplant for Relapsed/Refractory Diffuse Large B Cell Lymphoma Patients.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center study open-label trial will enroll a single cohort of relapsed/refractory diffuse large B cell lymphoma (DLBCL) patients whom are ineligible for autologous stem cell transplant (ASCT) due to 1) insensitivity to salvage chemotherapy, or 2) inability to tolerate high-dose myeloablative chemotherapy. All patients will receive dual checkpoint blocking antibody (DCBA) therapy with established doses currently being used in phase III trials of ipilimumab (1mg/kg) and nivolumab (3mg/kg) given at three week intervals, two times before, and two times following "immunotransplant" in which T cells (in whole PBMCs) are cryopreserved and re-infused (adoptive T cell transfer or ATCT) following lymphodepleting chemotherapy regimen, currently being employed in adoptive T cell therapies.

Detailed description

First 6 patients will be part of Phase Ib. Phase Ib and Phase II: Will occur sequentially. Phase II will proceed only if toxicity is acceptable as determined in Phase Ib.

Conditions

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

Interventions

Type	Name	Description
DRUG	Ipilimumab	Ipilimumab (1mg/kg)
DRUG	Nivolumab	Nivolumab (3mg/kg)

Timeline

• Start date: 2018-05-14
• Primary completion: 2021-04-01
• Completion: 2021-04-01
• First posted: 2017-10-10
• Last updated: 2023-02-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study