Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms (NCT07382817) | Clinical Trial Compass
RecruitingPhase 1
Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms
United States33 participantsStarted 2026-02-18
Plain-language summary
The goal of this clinical research study is to find the highest tolerable dose of JV-394 (a type of autologous CAR-T cell therapy) that can be given to patients who have T/NK cell lymphoma that is relapsed or refractory. The safety and possible side effects of JV-394 will also be studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
β. β₯18 years of age.
β. Confirmed T/NK cell malignancies as per local histopathological assessment.
β. Relapsed or refractory disease after at least one line of systemic therapy or intolerant to standard therapy for their cancer.
β. β₯50% of tumor cells are positive for CD94 by flow cytometry or IHC. Historical documentation of CD94 expression in the tumor is acceptable if available. If there is no historical documentation of CD94 expression, testing of archival tumor tissue or fresh tumor biopsy is required. Testing of archival tumor tissue may be done by IHC following a prescreening consent.
β. At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic anti-cancer therapy or 1 week from prior radiation therapy prior to leukapheresis.
β. ECOG performance status of 0-1 (Appendix 1).
β. For non-cutaneous lymphomas, at least one measurable lesion as per Lugano 2014 classification. Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen 2021 criteria.
Exclusion criteria
β. Subjects with aggressive NK cell leukemia and indolent T/NK cell malignancies such as TLGL or NK-LGL.
What they're measuring
1
Safety and Adverse Events (AEs)
Timeframe: Through study completion; an average of 1 year
β. Patients with tumor cells in the peripheral blood β₯1% of lymphocytes as determined by flow cytometry.
β. Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients with prior CNS lymphoma that has been effectively treated will be eligible if treatment was completed at least one year prior to enrolment and there is no evidence of disease on MRI with gadolinium contrast at the time of screening.
β. Autologous stem cell transplantation within 6 weeks.
β. Allogeneic cell transplantation within 3 months or active graft versus host disease.
β. History of any form of primary immunodeficiency that in the opinion of the investigator may affect efficacy of the CAR T product.
β. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.
β. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years and treated with curative intent. Patients with a prior history of malignancy whose natural history or treatment (e.g. hormonal therapy) does not have the potential to interfere with either the safety or efficacy assessment of the investigational regimen in the opinion of the investigator may be included.