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Nivolumab/Ipilimumab-Primed Immunotransplant for DLBCL

NCT03305445 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Ipilimumab

Ipilimumab (1mg/kg)

DRUG

Nivolumab

Nivolumab (3mg/kg)

Sponsors & Collaborators

Principal Investigators

  • Joshua Brody, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-14
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03305445 on ClinicalTrials.gov