CD19 CAR T-Cell Therapy for Scleroderma

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Kyverna Therapeutics

Disqualifiers: HIV, Hepatitis B/C, Neurologic disorders, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects with Systemic Sclerosis

Will I have to stop taking my current medications?

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

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

Research shows that anti-CD19 CAR T-cell therapy has been effective in treating B-cell cancers by targeting CD19, a protein found on cancerous B cells, leading to long-term remissions in some patients. This suggests that the therapy has potent activity against cells expressing CD19, which could potentially be beneficial in other conditions where CD19 is involved. ^{1 2 3 4 5}

How is the CD19 CAR T-Cell treatment for scleroderma different from other treatments?

CD19 CAR T-Cell therapy is unique because it uses genetically modified T cells to target and destroy B cells, which are involved in autoimmune diseases like scleroderma. This approach is novel compared to traditional treatments, as it directly modifies the immune system to reduce disease activity and has shown promise in similar autoimmune conditions like systemic lupus erythematosus. ^{1 6 7 8 9}

Research Team

MD

Principal Investigator

Kyverna Therapeutics, Inc.

Eligibility Criteria

This trial is for people with a condition called systemic sclerosis, specifically the diffuse cutaneous type. They should be within 6 years of their first symptom that's not Raynaud's phenomenon and have active disease. Participants must also be current on vaccinations recommended for those with weakened immune systems.

Inclusion Criteria

Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals

My skin condition was diagnosed as diffuse cutaneous SSc within the last 6 years and is still active.

I have been diagnosed with systemic sclerosis.

Exclusion Criteria

I have a serious lung condition.

I have previously received CAR-T or gene therapy.

I have had a stem cell transplant.

Trial Timeline

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

52 weeks

Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

Treatment Details

Interventions

• KYV-101 (CAR T-cell Therapy)

Trial Overview The study is testing KYV-101, which is a type of CAR T-cell therapy targeting CD19, an antigen found on certain cells in the body. This therapy will be compared to or combined with standard treatments that reduce the number of lymphocytes (a type of white blood cell).

Participant Groups

Group I: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2) Experimental Treatment 2 Interventions

Recommended Phase 2 Dose

Group II: KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1) Experimental Treatment 2 Interventions

Dosing with KYV-101 CAR T cells

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Northwell Health Great Neck, NY

Stanford University Medical Center Palo Alto, CA

Who Is Running the Clinical Trial?

Kyverna Therapeutics

Lead Sponsor

Trials

11

Patients Recruited

320+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors. Kochenderfer, JN., Rosenberg, SA.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I/IIa Trial Using CD19-Targeted Third-Generation CAR T Cells for Lymphoma and Leukemia. Enblad, G., Karlsson, H., Gammelgård, G., et al.[2019]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A CD19/Fc fusion protein for detection of anti-CD19 chimeric antigen receptors. De Oliveira, SN., Wang, J., Ryan, C., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Donor CD19 CAR T cells exert potent graft-versus-lymphoma activity with diminished graft-versus-host activity. Ghosh, A., Smith, M., James, SE., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adoptive transfer of syngeneic T cells transduced with a chimeric antigen receptor that recognizes murine CD19 can eradicate lymphoma and normal B cells. Kochenderfer, JN., Yu, Z., Frasheri, D., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cytokine and reactivity profiles in SLE patients following anti-CD19 CART therapy. Nunez, D., Patel, D., Volkov, J., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CD19-targeted CAR regulatory T cells suppress B cell pathology without GvHD. Imura, Y., Ando, M., Kondo, T., et al.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Mackensen, A., Müller, F., Mougiakakos, D., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor T-Cell Therapies for Aggressive B-Cell Lymphomas: Current and Future State of the Art. Abramson, JS., Lunning, M., Palomba, ML.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Treating B-cell cancer with T cells expressing anti-CD19 chimeric antigen receptors. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Phase I/IIa Trial Using CD19-Targeted Third-Generation CAR T Cells for Lymphoma and Leukemia. [2019]

3. England pubmed.ncbi.nlm.nih.gov

A CD19/Fc fusion protein for detection of anti-CD19 chimeric antigen receptors. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Donor CD19 CAR T cells exert potent graft-versus-lymphoma activity with diminished graft-versus-host activity. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Adoptive transfer of syngeneic T cells transduced with a chimeric antigen receptor that recognizes murine CD19 can eradicate lymphoma and normal B cells. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Cytokine and reactivity profiles in SLE patients following anti-CD19 CART therapy. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

CD19-targeted CAR regulatory T cells suppress B cell pathology without GvHD. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Chimeric Antigen Receptor T-Cell Therapies for Aggressive B-Cell Lymphomas: Current and Future State of the Art. [2021]