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Lupus NephritisPhase 1/2NCT06342960

KYSA-3: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

A Phase 1/2 study testing KYV-101 anti-CD19 CAR-T cell therapy and Standard lymphodepletion regimen in people with Lupus Nephritis and Lupus Nephritis - WHO Class III, run by Kyverna Therapeutics at 6 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KYV-101 anti-CD19 CAR-T cell therapy and Standard lymphodepletion regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
6 sitesGermany
Study dates
1 Dec 2022to 22 Dec 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years
  • Clinical diagnosis of SLE according to 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria
  • Biopsy-proven proliferative LN Class III or IV according to 2018 International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria
  • Positive anti-nuclear antibody (ANA) (titer ≥1:80 ), anti-dsDNA (≥30 IU/mL on enzyme-linked immunosorbent assay [ELISA]), or anti-Smith at screening or by documented medical history
  • Up to date on recommended vaccinations, including against coronavirus disease 2019/ severe acute respiratory syndrome coronavirus 2 (Covid-19/SARS-Cov-2), per Centers for Disease Control and Prevention (CDC) or institutional guidelines for immune compromised individuals

Who cannot join

  • Rapidly progressive glomerulonephritis; history of or currently active severe central nervous system (CNS) lupus, including cerebritis, cerebrovascular accident, and seizures
  • Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
  • History of allogeneic or autologous stem cell transplant
  • Evidence of active hepatitis B or hepatitis C infection
  • Positive serology for HIV
  • Primary immunodeficiency
Show all 13Show fewer
  • History of splenectomy
  • History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject.
  • Impaired cardiac function or clinically significant cardiac disease
  • Previous or concurrent malignancy with the following exceptions:
  • Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
  • In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
  • A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Germany6 sites

  • Charite- Universitätsklinikum Berlin

    Berlin

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden

  • Universitätsklinikum Düsseldorf

    Düsseldorf

  • Universitätsklinikum Erlangen

    Erlangen

  • Fraunhofer-Institut für Translationale Medizin und Pharmakologie ITMP

    Frankfurt

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg

Other trials in Germany

About this study

Official title: KYSA-3: A Phase 1/2, Open-Label, Multicenter Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis

A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Refractory Lupus Nephritis

Read the detailed description

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by a wide spectrum of organ involvement and disease severity. Renal involvement (categorized as lupus nephritis [LN]) may occur in approximately 50% of SLE patients and is marked by proteinuria, microscopic hematuria, and varying degrees of renal insufficiency. B cells play a central role in the pathogenesis of SLE and LN, with autoantibodies developing as an early finding, and local, tissue resident B cells producing pathogenic autoantibodies and driving inflammation and tissue damage over time. CD19-targeted chimeric antigen receptor (CAR) T cells harness the ability of cytotoxic T cells to directly and specifically lyse target cells to effectively deplete B cells in the circulation and in lymphoid and potentially non-lymphoid tissues. KYV-101, a fully human anti-CD19 CAR T-cell therapy, will be investigated in adult subjects with refractory lupus nephritis.

Being tested
KYV-101 anti-CD19 CAR-T cell therapy, Standard lymphodepletion regimen
Keywords
KYV-101, glomerulonephritis, autoimmune disease, anti-CD19 CAR-T therapy, cellular therapy, SLE, Systemic lupus erythematosus
Medical subject headings
Lupus Nephritis, Glomerulonephritis, Autoimmune Diseases, Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KYV-101 anti-CD19 CAR-T cell therapyBiological

    KYV-101 anti-CD19 CAR-T cell therapy

  • Standard lymphodepletion regimenDrug

    Also called Cyclophosphamide, Fludarabine

    Standard lymphodepletion regimen

Study groups in NCT06342960
Study groupRoleWhat they receive
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 1)ExperimentalDosing with KYV-101 CAR T cells
Receives: Biological: KYV-101 anti-CD19 CAR-T cell therapy; Drug: Standard lymphodepletion regimen
KYV-101 CAR-T cells with lymphodepletion conditioning (Phase 2)ExperimentalRecommended Phase 2 Dose
Receives: Biological: KYV-101 anti-CD19 CAR-T cell therapy; Drug: Standard lymphodepletion regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence adverse events (AEs) and laboratory abnormalities (Phase 1 and Phase 2)

    Measured: Up to 2 years

  2. Frequency of dose limiting toxicities (Phase 1)

    Measured: Up to 2 years

Secondary outcomes (15)

  1. To characterize the pharmacokinetics (PK) (Phase 1 and 2)

    Levels of KYV-101 CAR-positive T cells in the blood

    Measured: Up to 2 years

  2. To characterize the pharmacokinetics (PK) (Phase 1 and 2)

    Levels of KYV-101 CAR Transgene

    Measured: Up to 2 years

  3. To characterize the pharmacodynamics (PD) (Phase 1 and 2)

    Levels of B cells in the blood

    Measured: Up to 2 years

  4. To characterize the pharmacodynamics (PD) (Phase 1 and 2)

    Levels of systemic cytokine concentrations in serum

    Measured: Up to 2 months

  5. To evaluate disease related biomarkers (Phase 1 and 2)

    Levels of anti-double stranded DNA (anti-dsDNA) in serum

    Measured: Up to 2 years

  6. To evaluate disease related biomarkers (Phase 1 and 2)

    Levels of complement C3, C4 in serum

    Measured: Up to 2 years

  7. To evaluate efficacy of KYV-101 (Phase 1 and 2)

    Complete renal response rates (CRR)

    Measured: 12, 24, and 52 weeks

  8. To evaluate efficacy of KYV-101 (Phase 1 and 2)

    Time to Complete renal response (CRR)

    Measured: Up to 2 years

  9. To evaluate efficacy of KYV-101 (Phase 1 and 2)

    Time from first achieved Complete renal response (CRR) to disease worsening or end of study

    Measured: Up to 2 years

  10. To evaluate the immunogenicity (humoral response) of KYV-101 (Phase 1 and 2)

    Percentage of participants who develop anti-KYV-101 antibodies by immunoassays

    Measured: Up to 2 years

  11. To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)

    Change from baseline in 36-Item Short Form Survey (SF-36)

    Measured: Up to 2 years

  12. To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)

    Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F)

    Measured: Up to 2 years

  13. To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)

    Change from baseline in Lupus Quality of Life (Qol) Questionnaire

    Measured: Up to 2 years

  14. To access Patient Related Outcome (PRO) after infusion of KYV-101 (Phase 1 and 2)

    Change from baseline in Work Productivity and Activity Impairment (WPAI)

    Measured: Up to 2 years

  15. To define the recommended Phase 2 dose (Phase 1)

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2024
  2. Study start1 Dec 2022
  3. Primary completion22 Dec 2025
  4. Study completion22 Dec 2025

Why it stopped: Study discontinued due to sponsor decision.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06342960
Sponsor's protocol ID
KYSA-3
Other IDs
KYV101-003
Status last verified
Aug 2026
First submitted
27 Mar 2024
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Brudno JN, Lam N, Vanasse D, Shen YW, Rose JJ, Rossi J, Xue A, Bot A, Scholler N, Mikkilineni L, Roschewski M, Dean R, Cachau R, Youkharibache P, Patel R, Hansen B, Stroncek DF, Rosenberg SA, Gress RE, Kochenderfer JN. Safety and feasibility of anti-CD19 CAR T cells with fully human binding domains in patients with B-cell lymphoma. Nat Med. 2020 Feb;26(2):270-280. doi: 10.1038/s41591-019-0737-3. Epub 2020 Jan 20.

    PubMed 31959992

  • Mackensen A, Muller F, Mougiakakos D, Boltz S, Wilhelm A, Aigner M, Volkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rosler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Kronke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15.

    PubMed 36109639

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing KYV-101 anti-CD19 CAR-T cell therapy and Standard lymphodepletion regimen in people with Lupus Nephritis and Lupus Nephritis - WHO Class III, run by Kyverna Therapeutics at 6 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Study discontinued due to sponsor decision.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence adverse events (AEs) and laboratory abnormalities (Phase 1 and Phase 2) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06342960, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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