MG4101 Plus Rituximab Including Lymphodepletion in Patient With r/r NHL B-cell Origin

Sponsor
GC Cell Corporation
Study ID
NCT03778619
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Refractory Non-Hodgkin Lymphoma
  • Relapsed Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    weekly administration of Rituximab 375mg/m2 during cycle 1 and 2, monthly administration from cycle 3(up to cycle 6)
  • Fludarabine — DRUG
    administration of fludarabine 20mg/m2 for 3 consecutive days starting at 3 days before the 1st, 3rd, and 5th cycle of the first rituximab infusion for that cycle
  • Cyclophosphamide — DRUG
    administration of fludarabine 250mg/m2 for 3 consecutive days starting at 3 days before the 1st, 3rd, and 5th cycle of the first rituximab infusion for that cycle
  • MG4101(allogeneic Natural Killer cell) — BIOLOGICAL
    administration every fortnight for each cycle, beginning with the 1st dose of rituximab for that cycle.
  • Interleukin-2 — DRUG
    1 x 10\^6 IU/m2, together with MG4101

Study Details

To determine the efficacy and safety of combined therapy of determined MG4101 dose and Rituximab.

Key Dates

Start date
Nov 28, 2018
Status verified
Jul 2020
Primary completion
Apr 20, 2020
Completion
Oct 30, 2020

Study Design

Enrollment
9 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: single arm
    1. Phase 1 1. MG4101 (Allogeneic Natural Killer cell): i.v bi-weekly * Group 1: 1 x 10\^7 cells/㎏ * Group 2: 3 x 10\^7 cells/㎏ * Group 3: 9 x 10\^7 cells/㎏ 2. Interleukin-2 (IL-2): s.c bi-weekly with MG4101 at 1X10\^6 IU/m2 per day. 3. Rituximab: 375mg/m2. i.v. weekly for the first 2 cycles only (8 doses). monthly (3-6 cycle) 4. Lymphodepletion: Fludarabine 20mg/m2 + Cyclophosphamide 250 mg/m2 i.v. D-3, D-2, D-1 of 1st, 3rd, and 5th cycle 2. Phase 2a Administration of recommended dosage of MG4101 determined from Phase 1 will be applied in Phase 2a. Dosage regimens for lymphodepletion, IL-2 and Rituximab will be the same as Phase 1.

Primary Outcome Measure

Phase I - Maximum Tolerated Dose of the dose of MG4101 in combination with Rituximab [ Time Frame: 28 days ]

Related Studies