Back to resultsEvaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
Primary Purpose
Non-Hodgkin Lymphoma
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GDA-201
Sponsored by
About this trial
This is an interventional treatment trial for Non-Hodgkin Lymphoma focused on measuring lymphoma, GDA-201, NK cells, rituximab, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
Eligibility Criteria
Inclusion Criteria:
Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows:
- Received at least 2 prior lines of therapy
- Transplant ineligible patients allowed assuming they meet criterion a.
- Patients who received prior chimeric antigen receptor modified T-cells (CAR-T) cell therapy or are considered ineligible for CAR-T therapy per the investigator's discretion
- FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL
- Patients must be at least 18 years of age
- Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.
Exclusion Criteria:
- CNS lymphoma
Time between previous treatment and first dose of study treatment (rituximab):
- Allogeneic HSCT < 6 months prior to study treatment
- Autologous HSCT < 3 months prior to study treatment
- CAR-T < 2 months prior to study treatment
Sites / Locations
- Mayo Clinic JacksonvilleRecruiting
- Loyola University, Cardinal Bernardin Cancer CenterRecruiting
- Dana-Farber/Mass General Brigham Cancer Care, Inc.Recruiting
- Henry Ford Medical CenterRecruiting
- Regents of the University of MinnesotaRecruiting
- Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
GDA-201
Arm Description
Phase 1 dose escalation with up to 4 dose levels to reach MTD and determine recommended phase 2 dose (RP2D). Phase 2 RP2D will be administered to all patients.
Outcomes
Primary Outcome Measures
Phase 1: Safety as determined by dose limiting toxicities (DLTs)
DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. aGvHD will be assessed according to the Consensus Conference on Acute GvHD grading:
Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extended to confirm)
Phase 2: overall response rate
Patients will be assessed after the infusion of GDA-201 for level of response.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05296525
Brief Title
Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
Official Title
A Phase I/II Multicenter Study Evaluating the Safety and Efficacy of Allogeneic GDA-201 Natural Killer Cells in Patients With Relapsed/Refractory B Cell Non-Hodgkin Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 5, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gamida Cell ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is an open-label, non-randomized, interventional, single group assignment study of GDA-201, an allogeneic cryopreserved NK cell therapy derived from donor peripheral blood, in combination with rituximab, monoclonal anti-CD20 antibody, for patients with relapsed or refractory B Cell non-Hodgkin lymphoma (NHL).
Detailed Description
The study is divided into a phase I dose escalation phase and a phase II expansion phase.
Patients with relapsed or refractory follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL)/high grade B-cell lymphoma (HGBCL) will receive GDA-201 followed by a short course of low-dose interleukin-2 (IL-2). Rituximab will be administered prior to and after GDA-201 infusion.
Phase I: Dose escalation phase The objective of Phase I is to evaluate the safety of GDA-201 in patients with FL, DLBCL/ HGBCL, marginal zone lymphoma or mantle cell lymphoma. The maximal tolerated dose (MTD) and recommended Phase II Dose (RP2D) will be determined based on dose limiting toxicities (DLT).
Phase II expansion phase The objective of the Phase II expansion cohort is to evaluate the safety and efficacy of GDA-201 in two patient cohorts, FL and DLBCL/HGBCL.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma
Keywords
lymphoma, GDA-201, NK cells, rituximab, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GDA-201
Arm Type
Other
Arm Description
Phase 1 dose escalation with up to 4 dose levels to reach MTD and determine recommended phase 2 dose (RP2D).
Phase 2 RP2D will be administered to all patients.
Intervention Type
Drug
Intervention Name(s)
GDA-201
Other Intervention Name(s)
NAM NK
Intervention Description
NAM-expanded allogeneic NK cells
Primary Outcome Measure Information:
Title
Phase 1: Safety as determined by dose limiting toxicities (DLTs)
Description
DLTs defined as one of the following within the first 28 days of the first dose of GDA-201 by the NCI-CTCAE v 5.0. aGvHD will be assessed according to the Consensus Conference on Acute GvHD grading:
Steroid refractory Grade II aGvHD, defined as GvHD that does not respond to at least 1 mg/kg/day or equivalent of prednisone within 7 days of initiating therapy Grade III or IV aGvHD Grade 4 infusion reaction Grade 4 or 5 related adverse event (AE) Grade 3 or above cardiac, central nervous system or pulmonary adverse event. Any Grade 3 or above non-hematologic adverse event that does not resolve to Grade 2 or below within 72 hours, except for renal or hepatic adverse events which may take up to 7 days to resolve Treatment emergent ≥Grade 3 autoimmune disorder Grade 3 or above allergic reaction that does not recover to Grade II or below within 24 hours Grade 4 cytopenia lasting beyond Day 42 (the 28-day DLT observation period will be extended to confirm)
Time Frame
Day 28
Title
Phase 2: overall response rate
Description
Patients will be assessed after the infusion of GDA-201 for level of response.
Time Frame
up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have relapsed/refractory FL or HGBCL/DLBCL that has failed conventional therapy defined as follows:
Received at least 2 prior lines of therapy
Transplant ineligible patients allowed assuming they meet criterion a.
Patients who received prior chimeric antigen receptor modified T-cells (CAR-T) cell therapy or are considered ineligible for CAR-T therapy per the investigator's discretion
FL transformed to HGBCL: Must have received at least 1 line of therapy after transformation to DLBCL/HGBCL
Patients must be at least 18 years of age
Patients must have adequate hematologic, hepatic, renal, cardiac and pulmonary function prior to any study treatment.
Exclusion Criteria:
CNS lymphoma
Time between previous treatment and first dose of study treatment (rituximab):
Allogeneic HSCT < 6 months prior to study treatment
Autologous HSCT < 3 months prior to study treatment
CAR-T < 2 months prior to study treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurelie Schwarzbach
Phone
+972556660324
Email
aurelie@gamida-cell.com
Facility Information:
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhamad Alhaj Moustafa, MD
Phone
904-953-0853
First Name & Middle Initial & Last Name & Degree
Muhamad Alhaj Moustafa, MD
Facility Name
Loyola University, Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Tsai, MD
Phone
708-327-3308
First Name & Middle Initial & Last Name & Degree
Stephanie Tsai, MD
Facility Name
Dana-Farber/Mass General Brigham Cancer Care, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Frigault, MD
Phone
617-726-5130
First Name & Middle Initial & Last Name & Degree
Matthew Frigault, MD
Facility Name
Henry Ford Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward Peres, MD
Phone
888-734-5322
First Name & Middle Initial & Last Name & Degree
Edward Peres, MD
Facility Name
Regents of the University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronika Bachanova, MD
Phone
612-625-8287
First Name & Middle Initial & Last Name & Degree
Veronika Bachanova, MD
Facility Name
Memorial Sloan Kettering Cancer Center (MSKCC) - Memorial Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Shaffer, MD
Phone
877-836-2268
First Name & Middle Initial & Last Name & Degree
Brian Shaffer, MD
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With Relapsed/Refractory B Cell NHL
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