Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT06916767
Status:
RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Sponsor:
Paolo Caimi, MD
Organization:
Study Overview
Official Title:
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
CAR-T cell treatment of refractory lymphoma has shown success, particularly with CD-19 targeted CAR-T cells, however, many participants are refractory or relapse after response. Responses are more limited in CLL/SLL, possibly secondary to the suppressive effect of circulating B cells on T cell function.
BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.
BAFF receptor is a target that has been explored in CLL. Preclinical data indicates that CAR- T cells expressing B-cell activating factor (BAFF) can be another effective strategy to treat refractory CLL. This study aims to explore the efficacy of LMY-920 a BAFF-ligand CAR T cells with depletion of B cells with Obinutuzumab prior to apheresis.
Detailed Description:
There is a persistent need for development of new, effective therapies for treatment of B cell malignancies. Therapy with CAR-T cells has demonstrated activity against refractory lymphoma, however not all tumors respond or remain in response to CD19 targeted CAR-T cells. While CAR T-cells have activity against CLL/SLL, the rates of response are more limited than non Hodgkin lymphoma. Based on preclinical data of anti BAFF-R CAR T-cells13 as well as preclinical and early phase studies using anti-BAFF-R monoclonal antibodies in CLL) investigators posit that CAR-T cells expressing BAFF (BAFF CAR-T cells, LMY-920 can become another strategy to treat refractory CLL.
This study will evaluate the safe dose and provide initial signal of the activity of BAFF CAR- T cells against relapsed CLL/SLL using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process that can be replicated in multiple academic institutions with the appropriate cellular manufacturing facilities.
This study will evaluate the safe dose and provide initial signal of the activity of BAFF CAR- T cells against relapsed CLL/SLL using a single lymphodepletion regimen and using a BAFF CAR-T cell manufacturing process that can be replicated in multiple academic institutions with the appropriate cellular manufacturing facilities.
Study Oversight
Has Oversight DMC:
True
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?: