NCT03920631

Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas

MicroBLITZ: Microtransplantation and Checkpoint Blockade Immunotherapy for Relapsed or Refractory B Cell Lymphomas

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ahmed Galal, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to find out if microtransplantation (MST) in combination with nivolumab is safe and effective in patients with relapsed or refractory B cell lymphomas.

Detailed description

This is a non-randomized, open-label, phase 1 study to assess the safety of nivolumab (OPDIVO™, also referred to as BMS-936558, MDX1106, and ONO-4538) in combination with microtransplantation (MST) in patients ≥ 18 years of age with relapsed or refractory B cell lymphomas. A conventional cohorts-of-3 dose-escalation phase I design will be used to determine the optimal dosing strategy of nivolumab in combination with MST. The safety of microtransplantation without nivolumab will be evaluated at the first dose level. If significant, unexpected toxicity is observed at Dose Levels 2 or 3, subsequent cohorts will switch to the alternate dosing schedule to evaluate the safety of dose-reduced nivolumab. After determination of the maximum tolerated dose level, patients will be recruited into an expansion cohort at that level.

Conditions

• B Cell Lymphomas

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab (1 mg/Kg or 3 mg/kg) every 2 weeks per cohort dose level and schedule
BIOLOGICAL	Microtransplantation	HLA-mismatched peripheral blood stem cells

Timeline

• Start date: 2020-07-10
• Primary completion: 2023-03-15
• Completion: 2023-05-15
• First posted: 2019-04-19
• Last updated: 2021-03-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study