32 Participants Needed

CAR T-Cell Therapy for Lupus Nephritis

Recruiting at 5 trial locations
KT
Overseen ByKyverna Therapeutics
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Kyverna Therapeutics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new treatment that uses modified immune cells to target and destroy harmful cells in adults with severe kidney inflammation from lupus that doesn't respond to usual treatments.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is CAR T-Cell Therapy safe for humans?

CAR T-Cell Therapy targeting CD19 has been generally well tolerated in patients with systemic lupus erythematosus (SLE), with only mild side effects like cytokine-release syndrome (a mild immune reaction). Safety data from these studies suggest it is feasible and tolerable in humans.12345

How is the treatment KYV-101 for lupus nephritis different from other treatments?

KYV-101, a CAR T-cell therapy, is unique because it uses modified immune cells to target and destroy specific B cells involved in lupus nephritis, potentially leading to long-term remission without ongoing medication. This approach differs from traditional treatments like corticosteroids and immunosuppressive drugs, which broadly suppress the immune system and often have significant side effects.12356

What data supports the effectiveness of the treatment KYV-101, Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, for lupus nephritis?

Research shows that anti-CD19 CAR T-cell therapy has been effective in treating systemic lupus erythematosus (SLE), a related condition, by reducing disease activity and achieving remission in patients who did not respond to other treatments. This suggests potential effectiveness for lupus nephritis, which is a kidney-related complication of SLE.12367

Who Is on the Research Team?

M

MD

Principal Investigator

Kyverna Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a clinical diagnosis of Systemic Lupus Erythematosus (SLE) who meet specific criteria, including positive tests for certain autoantibodies and biopsy-proven proliferative lupus nephritis. Participants must be up to date on vaccinations, including COVID-19. Those with severe neurological disorders, active hepatitis B or C, HIV, primary immunodeficiency, significant heart disease or previous malignancies (with some exceptions), or prior cellular/gene therapy are excluded.

Inclusion Criteria

I have been diagnosed with lupus according to the 2019 EULAR/ACR criteria.
My kidney biopsy shows I have a severe type of inflammation.
I am up to date with all recommended vaccinations, including COVID-19.
See 1 more

Exclusion Criteria

You have a weakened immune system from birth.
I have previously received CAR-T or gene therapy.
I have severe kidney inflammation or serious brain-related lupus symptoms.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepletion Conditioning

Participants undergo lymphodepletion conditioning prior to receiving KYV-101 CAR T cells

1-2 weeks

Treatment

Participants receive KYV-101 CAR T-cell therapy

Up to 52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • KYV-101
Trial Overview The study is testing KYV-101 anti-CD19 CAR-T cell therapy in subjects with refractory lupus nephritis that hasn't responded to other treatments. It involves modifying the patient's T-cells to target CD19 protein on B cells implicated in SLE. The treatment follows a standard lymphodepletion regimen which prepares the body for receiving these modified T-cells.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)Experimental Treatment2 Interventions
Group II: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)Experimental Treatment2 Interventions

KYV-101 is already approved in United States for the following indications:

🇺🇸
Approved in United States as KYV-101 for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kyverna Therapeutics

Lead Sponsor

Trials
11
Recruited
320+

Published Research Related to This Trial

In a small study of five treatment-resistant patients with systemic lupus erythematosus (SLE), CD19 CAR T cell therapy led to significant clinical improvements and remission in all participants after 3 months, demonstrating its potential efficacy.
The treatment was well tolerated, with only mild cytokine release syndrome reported, suggesting a favorable safety profile for this innovative therapy in seriously ill SLE patients.
Journal Club: Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus.Boulougoura, A., Gendelman, H., Surmachevska, N., et al.[2023]
In a study of six patients with refractory systemic lupus erythematosus (SLE), anti-CD19 CAR T cell therapy was found to be well tolerated and led to a significant reduction in inflammatory cytokines IL-6 and TNFα three months after treatment.
The therapy also resulted in a marked decrease in SLE-associated antibodies in five out of six patients, suggesting a potential mechanism for its efficacy in managing SLE symptoms.
Cytokine and reactivity profiles in SLE patients following anti-CD19 CART therapy.Nunez, D., Patel, D., Volkov, J., et al.[2023]
In a study involving five patients with severe systemic lupus erythematosus (SLE), treatment with CAR T cells targeting CD19 led to complete remission of the disease in all participants after 3 months, demonstrating high efficacy.
The CAR T cell therapy was well tolerated, with only mild side effects, and patients maintained drug-free remission for an average of 8 months, even after B cells reappeared, indicating a durable response to the treatment.
Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus.Mackensen, A., Müller, F., Mougiakakos, D., et al.[2023]

Citations

Journal Club: Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Refractory Systemic Lupus Erythematosus. [2023]
Cytokine and reactivity profiles in SLE patients following anti-CD19 CART therapy. [2023]
Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. [2023]
Progress in the treatment of proliferative lupus nephritis. [2019]
Novel approaches in the treatment of lupus nephritis. [2019]
Sustained B cell depletion by CD19-targeted CAR T cells is a highly effective treatment for murine lupus. [2021]
Successful Generation of CD19 Chimeric Antigen Receptor T Cells from Patients with Advanced Systemic Lupus Erythematosus. [2023]
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