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BAFF CAR-T

Phase 1

Lymphoma, Non-Hodgkin Lymphoma, B-Cell | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Oct 21, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

BAFF CAR-T · 1 trial · 1 indication

Phase 1 1
NCT05312801Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin LymphomaLymphoma, Non-Hodgkin Lymphoma, B-Cell
RECRUITING20 Analytics
PHASE1RECRUITING
Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma
Lymphoma, Non-Hodgkin Lymphoma, B-CellUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine recommended phase II dose of human LMY-920.
24 months

Maximum tolerated dose.

Secondary Endpoints

To establish toxicity profile for the infusion of LMY-920.
24 months
To determine the objective response rate .
24 months
To determine the complete response rate.
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LMY-920 dose escalationEXPERIMENTALOpen label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.

Interventions

NameTypeDescription
BAFF CAR-TDRUGAutologous CAR-T cell therapy expressing the BAFF-ligand.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Subjects must have histologically confirmed non-Hodgkin lymphoma relapsed after 2 or more lines of therapy or disease refractory to chemotherapy (defined as progressive disease or stable disease lasting ≤6 months, as best response to most recent chemotherapy regimen; or disea...

Countries:United States
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Frequently asked questions about BAFF CAR-T

What is BAFF CAR-T used for?

BAFF CAR-T is an investigational cell therapy being studied for the treatment of B-cell non-Hodgkin lymphoma, including lymphoma. It is currently in Phase 1 clinical development and has not been approved by the FDA.

What does BAFF CAR-T target?

BAFF CAR-T is designed to target BAFF, a protein involved in B-cell survival and proliferation. By engineering a patient's T cells to recognize BAFF, the therapy aims to attack malignant B cells in non-Hodgkin lymphoma.

Who is developing BAFF CAR-T?

BAFF CAR-T is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The therapy is currently in Phase 1 clinical trials.

What phase is BAFF CAR-T in?

BAFF CAR-T is in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities and is still being evaluated for safety and efficacy in clinical trials.

What clinical trials is BAFF CAR-T in?

BAFF CAR-T is being studied in a Phase 1 clinical trial with the identifier NCT05312801. This trial is recruiting participants with B-cell non-Hodgkin lymphoma in the United States and aims to enroll approximately 20 patients.

Is BAFF CAR-T the same as LMY-920?

Yes, BAFF CAR-T is also known as LMY-920. The Phase 1 clinical trial for this therapy is titled 'Phase 1 Study of BAFF CAR-T Cells (LMY-920) for Non-Hodgkin Lymphoma,' confirming that both names refer to the same investigational cell therapy.