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BCMA-CD19 cCAR T cells

Phase 1

Refractory Immune Cytopenia | Monoclonal antibody | Other |cbdMD, Inc.|Last Updated: Jan 22, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

BCMA-CD19 cCAR T cells · 1 trial · 1 indication

Phase 1 1
NCT06787989BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune DiseasesRefractory Immune Cytopenia
RECRUITING20 Analytics
PHASE1RECRUITING
BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases
Refractory Immune CytopeniaUnlock trial analytics

Study Endpoints

Primary Endpoints

The number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion
24 months

Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after BCMA-CD19 cCAR infusion.

Secondary Endpoints

Overall remission rate 12 weeks after BCMA-CD19 cCAR
24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BCMA-CD19 cCAR T cellsEXPERIMENTALDose escalation phase: patient's T cells will be transduced with a retroviral vector to express a BCMA-CD19 cCAR. with an escalation approach.

Interventions

NameTypeDescription
BCMA-CD19 cCAR T cellsBIOLOGICAL• BCMA-CD19 cCAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Age: 18\~60 years old; 2. Diagnosed with immune thrombocytopenia associated with autoimmune diseases including systemic lupus erythematosus (according to the 1997 or 2009 ACR classification criteria), primary Sjogren's syndrome (according to the 2002 ACR/EULAR internationa...

Countries:China
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Frequently asked questions about BCMA-CD19 cCAR T cells

What is BCMA-CD19 cCAR T cells used for?

BCMA-CD19 cCAR T cells is an investigational cell therapy being studied for refractory immune cytopenia, a condition involving low blood cell counts associated with autoimmune diseases. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does BCMA-CD19 cCAR T cells target?

BCMA-CD19 cCAR T cells is designed to target BCMA and CD19, two proteins found on certain immune cells. By engineering T cells to recognize these targets, the therapy aims to address the underlying autoimmune response in refractory immune cytopenia.

Who is developing BCMA-CD19 cCAR T cells?

BCMA-CD19 cCAR T cells 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 for refractory immune cytopenia.

What phase is BCMA-CD19 cCAR T cells in?

BCMA-CD19 cCAR T cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not yet been approved by the FDA or other regulatory agencies. The ongoing trial is recruiting participants to evaluate its safety and efficacy.

What clinical trials is BCMA-CD19 cCAR T cells in?

BCMA-CD19 cCAR T cells is being studied in a Phase 1 clinical trial registered as NCT06787989, titled 'BCMA-CD19 CCAR T Cell Treatment of Refractory Immune Thrombocytopenia Associated with Autoimmune Diseases.' The trial is recruiting 20 participants in China and is not randomized or blinded.