Ignite Creation Date:
2024-05-06 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05296525
Status:
TERMINATED
Last Update Posted:
2024-05-02
First Post:
2022-03-16
Brief Title:
Evaluation of Safety and Efficacy of Allo GDA-201 NK Cells in Patients With RelapsedRefractory B Cell NHL
Sponsor:
Gamida Cell ltd
Organization:
Gamida Cell ltd
Study Overview
Official Title:
A Phase III Multicenter Study Evaluating the Safety and Efficacy of Allogeneic GDA-201 Natural Killer Cells in Patients With RelapsedRefractory B Cell Non-Hodgkin Lymphoma
Status:
TERMINATED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated by Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DLBCLhigh 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 DLBCLHGBCL
Patients with relapsed or refractory follicular lymphoma FL or diffuse large B-cell lymphoma DLBCLhigh 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 DLBCLHGBCL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None