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 — DRUGweekly administration of Rituximab 375mg/m2 during cycle 1 and 2, monthly administration from cycle 3(up to cycle 6)
- Fludarabine — DRUGadministration 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 — DRUGadministration 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) — BIOLOGICALadministration every fortnight for each cycle, beginning with the 1st dose of rituximab for that cycle.
- Interleukin-2 — DRUG1 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 arm1. 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 ]
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