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

Conditions

• B Cell Lymphomas

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Jul 10, 2020

Status verified

Mar 2021

Primary completion

Mar 15, 2023

Completion

May 15, 2023

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort 1: Microtransplantation (MST)
  MST:Infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
• Experimental: Cohort 2/2b: MST + Nivolumab
  2: Microtransplantation (Day 0) + nivolumab (3 mg/kg) every 2 weeks (beginning on Day+14) 2b: Microtransplantation (Day 0) + nivolumab (1 mg/kg) every 2 weeks (beginning on Day+14).
• Experimental: Cohort 3/3b: MST + Nivolumab
  3: Microtransplantation (Day 0) + nivolumab (3 mg/kg) every 2 weeks (beginning on Day-1). 3b: Microtransplantation (Day 0) + nivolumab (1 mg/kg) every 2 weeks (beginning on Day-1).
• Experimental: Cohort 4: Expansion
  Microtransplantation (Day 0) + nivolumab (at RP2D)

Primary Outcome Measure

Maximum Tolerated Dose of nivolumab in combination with Microtransplantation [ Time Frame: 1.5 years ]

Locations (1)

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