KYSA-5: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Systemic Sclerosis

Launched by KYVERNA THERAPEUTICS · May 1, 2024

Keywords

ClinConnect Summary

The KYSA-5 clinical trial is studying a new treatment called Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) therapy for patients with systemic sclerosis, a condition that causes hardening and tightening of the skin and connective tissues. This trial is specifically looking at individuals who have been diagnosed with a certain type of systemic sclerosis known as diffuse cutaneous systemic sclerosis and have had active symptoms for less than six years. The trial is currently recruiting participants aged 65 to 74, and it’s important that candidates are up to date on their vaccinations since this therapy can affect the immune system.

If you or a loved one are considering participation, you should know that there are specific eligibility criteria. For instance, participants should not have severe lung disease or a history of certain serious health issues, including previous stem cell transplants or significant heart problems. Throughout the trial, participants will receive close monitoring and care from healthcare professionals. This trial represents an important step toward finding new treatments for systemic sclerosis, and being involved could help contribute to advancements in care for this condition.

Gender

ALL

Eligibility criteria

• • Key Inclusion Criteria
• • 1. Clinical diagnosis of SSc according to 2013 ACR/EULAR classification
• • 2. Clinical disease as follows: Classified as diffuse cutaneous SSc; ≤ 6 years since first non-Raynaud's sign or symptom; active disease
• • 3. Up to date on all recommended vaccinations per CDC or institutional guidelines for immune-compromised individuals
• • Key Exclusion Criteria
• • 1. Clinically significant ILD
• • 2. Prior treatment with cellular therapy (CAR-T) or gene therapy product directed at any target
• • 3. History of allogeneic or autologous stem cell transplant
• • 4. Evidence of active hepatitis B or hepatitis C infection
• • 5. Positive serology for HIV
• • 6. Primary immunodeficiency
• • 7. History of splenectomy
• • 8. 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
• • 9. Impaired cardiac function or clinically significant cardiac disease
• 10. Previous or concurrent malignancy with the following exceptions:
• • 1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening)
• • 2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening
• • 3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening