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New treatment option for Dermatomyositis
Official title Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis
ClinicalTrials.gov ID: NCT06298019
What this study is testing
What is KYV-101?
KYV-101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for dermatomyositis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 72
You may be able to join if
- Diagnosis of probable or definite (\>55%) IIM and subgroup classification as dermatomyositis according to the 2017 EULAR/ACR classification criteria...
- Age \> 25 years and \ =19. PLUS at least 2 other abnormal IMACS Core Set Measures (CSMs) from the following:
- Patient global VAS≥2 cm.
- Physician's global VAS ≥2 cm.
- Global extramuscular activity score ≥2 cm.
You likely can't join if
- DM-related exclusion criteria
- Evidence of any of the following:
- Severe muscle damage as per one of the following criteria:
- Myositis Global Damage Index (MDI) ≥5.
- Severe proximal muscle atrophy of upper or lower extremity on MRI.
- Severe proximal muscle atrophy of upper or lower extremity on clinical examination.
See the full eligibility criteria
Who can join
- Diagnosis of probable or definite (\>55%) IIM and subgroup classification as dermatomyositis according to the 2017 EULAR/ACR classification criteria for idiopathic inflammatory myopathies.
- Age \> 25 years and \ =19. PLUS at least 2 other abnormal IMACS Core Set Measures (CSMs) from the following:
- Patient global VAS≥2 cm.
- Physician's global VAS ≥2 cm.
- Global extramuscular activity score ≥2 cm.
- Elevation of at least one of the muscle enzymes (CK, AST, ALT, aldolase, LDH) \>1.5 times upper limit of normal.
- HAQ-DI≥0.25. 2.For patients enrolling on the MMT-8 criterion, muscle disease must be active, as deemed by one of the following:
- Creatine kinase, aldolase, LDH, AST, or ALT (if deemed due to muscle inflammation by investigator) ≥2×ULN.
- MRI evidence of active myositis within last 3 months.
- EMG evidence of active myositis within last 3 months. Other Subject must sign a written ICF prior to any screening procedures.
- Subject must be ≥25 and ≦72 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as per table below. Haematology Haemoglobin: ≥10.0 g/dl (without prior red blood cell transfusion within 7 days before the laboratory test)a Platelets: ≥100,000/ μL (without transfusion support...
- Must be up to date on all recommended vaccinations, including against COVID-19/ SARS CoV-2, per Centers for Disease Control and Prevention or institutional guidelines for immune-compromised individuals.
- Women of childbearing potential must have a negative pregnancy test at screening using a highly sensitive serum pregnancy test (β-human chorionic gonadotropin [β-hCG]). Women of childbearing potential are defined as a...
- Female people of childbearing potential who have a fertile male sexual partner must agree to use a highly effective method of contraception (failure rate of \<1% per year when used consistently and correctly) from the...
- Established use of hormonal methods of contraception associated with inhibition of ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or male subject's female partner plans to remain...
- Correctly placed copper containing- intrauterine device or intrauterine hormone-replacing system.
- Male sterilization with absence of sperm in the post-vasectomy ejaculate.
- Female sterilization (bilateral tubal ligation/bilateral salpingectomy or bilateral tubal occlusive procedure (provided that occlusion has been confirmed).
- Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for...
- Male people, if not surgically sterilized, must agree to use highly effective method of contraception and not donate sperm from the time of signing the ICF until 1 year after the KYV-101 infusion.
- For females: a negative pregnancy test at screening and prior to lymphodepletion chemotherapy.
- Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a KYV-101 infusion.
What rules you out
- DM-related exclusion criteria
- Evidence of any of the following:
- Severe muscle damage as per one of the following criteria:
- Myositis Global Damage Index (MDI) ≥5.
- Severe proximal muscle atrophy of upper or lower extremity on MRI.
- Severe proximal muscle atrophy of upper or lower extremity on clinical examination.
- Wheelchair-bound at home.
- MMT-8 of ≤80.
- MDA5-positive rapidly progressing interstitial lung disease (people with stable ILD not requiring supplemental oxygen are eligible).
- Findings of muscular inflammation or myopathy other than the indication, such as polymyositis (PM), immune mediated necrotizing myopathy (IMNM), inclusion body myositis (IBM), cancer-associated myositis (myositis...
- Generalized, severe musculoskeletal or neuro-muscular conditions other than DM that prevent a sufficient assessment of the patient by the investigator.
- Subject with any of the following:
- Patients with ILD associated with any of the following oRequiring O2 therapy and/or FVC ≤45% of predicted or DLCO ≤40% of predicted at screening oEvidence of PH as defined as estimated RVSP or ≥45 mmHg or right atrial...
- Prior treatment with cellular immunotherapy (eg, CAR T) or gene therapy product directed at any target.
- History of allogeneic or autologous stem cell transplant.
- Systemic autoimmune disease, other than DM, requiring systemic immunosuppressive therapies
- Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, like the flu vaccine, are allowed). Unable to washout or interrupt autoimmune disease therapy prior to apheresis as specified in Table .
- Positive hepatitis B surface antigen (HBsAg) and hepatitis C serology confirmed by polymerase chain reaction (PCR) (except hepatitis C cured with pharmacotherapy); people who are HBsAg negative and hepatitis B core...
- Positive serology for human immunodeficiency virus (HIV).
- Positive screening test for SARS-Cov-2.
- Primary immunodeficiency.
- 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...
- Impaired cardiac function or clinically significant cardiac disease including:
- Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to apheresis.
- New York Heart Association (NYHA) stage III or IV congestive heart failure.
- History of clinically significant cardiac arrhythmia (eg, ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block.
- History of severe nonischaemic cardiomyopathy.
- Left ventricular ejection fraction (LVEF) \<45% as assessed by echocardiogram (ECHO)
- 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.
- Serious and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, such as:
- Active, uncontrolled, viral, bacterial or systemic fungal infection (including human T cell lymphotropic virus [HTLV], human polyomavirus 2 [JC virus], or syphilis); or recent history of repeated infections.
- Requirement of supplemental oxygen to maintain oxygen saturation.
- Clinical evidence of dementia or altered mental status.
- A thromboembolic event within 6 months prior to apheresis.
- Ongoing toxicity from previous therapy that has not resolved to baseline levels or to Grade 1 or less, except for alopecia, fatigue, nausea, and constipation.
- Major surgery within 4 weeks prior to apheresis or planned within 4 weeks after KYV-101 administration. For surgery planned after 4 weeks post KYV-101 administration, discuss with the sponsor.
- Contraindications or life-threatening allergies, hypersensitivity, or intolerance to KYV-101 or its excipients, including dimethyl sulfoxide; or to CYC (or to fludarabine if relevant), or to tocilizumab.
- Pregnant or breastfeeding; or plans to become pregnant or breastfeed, or father a child within 1 year after receiving the KYV-101 infusion.
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Stanford, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 72 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Stanford, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.