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New treatment option for Neoplasms
Official title Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms
ClinicalTrials.gov ID: NCT07382817
What this study is testing
What is JV-394?
JV-394 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neoplasms.
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 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.
- 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 18 and older
You may be able to join if
- ≥18 years of age.
- Confirmed T/NK cell malignancies as per local histopathological assessment.
- Relapsed or refractory disease after at least one line of systemic therapy or intolerant to standard therapy for their cancer.
- Eligible histologies include: extranodal NK/TCL, hepatosplenic TCL, primary cutaneous CD8+ aggressive epidermotropic cytotoxic TCL, subcutaneous...
- ≥50% of tumor cells are positive for CD94 by flow cytometry or IHC. Historical documentation of CD94 expression in the tumor is acceptable if...
You likely can't join if
- people with aggressive NK cell leukemia and indolent T/NK cell malignancies such as TLGL or NK-LGL.
- Patients with tumor cells in the peripheral blood ≥1% of lymphocytes as determined by flow cytometry.
- Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients...
- Autologous stem cell transplantation within 6 weeks.
- Allogeneic cell transplantation within 3 months or active graft versus host disease.
- History of any form of primary immunodeficiency that in the opinion of the investigator may affect how well it works of the CAR T product.
See the full eligibility criteria
Who can join
- ≥18 years of age.
- Confirmed T/NK cell malignancies as per local histopathological assessment.
- Relapsed or refractory disease after at least one line of systemic therapy or intolerant to standard therapy for their cancer.
- Eligible histologies include: extranodal NK/TCL, hepatosplenic TCL, primary cutaneous CD8+ aggressive epidermotropic cytotoxic TCL, subcutaneous panniculitis-like TCL, monomorphic epitheliotropic intestinal TCL...
- ≥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...
- 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.
- ECOG performance status of 0-1 (Appendix 1).
- For non-cutaneous lymphomas, at least one measurable lesion as per Lugano 2014 classification. people with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen 2021...
- Toxicities due to prior therapy must be stable and recovered to ≤grade 1 (except for clinically non-significant toxicities such as alopecia).
- Absolute neutrophil count of ≥1.0×109 /L.
- Absolute lymphocyte count of ≥0.1×109 /L.
- Platelet count of ≥75×109 /L.
- Creatinine clearance (as estimated by Cockcroft Gault) ≥45 mL/min.
- Serum alanine transaminase (ALT) / aspartate transaminase (AST) ≤5 times the upper limit of normal (ULN).
- Total bilirubin ≤2 mg/dL, except in patients with Gilbert's syndrome.
- Cardiac ejection fraction ≥45% with no evidence of clinically significant pericardial effusion.
- Baseline oxygen saturation ≥92% on room air.
- Women of childbearing potential must have a negative serum or urine pregnancy test (women who have had hysterectomy and women who are over the age of 45 years and have not had a menstrual period for at least 1 year are...
What rules you out
- people with aggressive NK cell leukemia and indolent T/NK cell malignancies such as TLGL or NK-LGL.
- Patients with tumor cells in the peripheral blood ≥1% of lymphocytes as determined by flow cytometry.
- 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...
- Autologous stem cell transplantation within 6 weeks.
- Allogeneic cell transplantation within 3 months or active graft versus host disease.
- History of any form of primary immunodeficiency that in the opinion of the investigator may affect how well it works of the CAR T product.
- 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...
- 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...
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis or localized...
- Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR...
- Active autoimmune (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) or inflammatory disease (including graft-versus-host disease) requiring systemic immunosuppressive therapy. Physiological...
- History or presence of CNS disorders such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Patients with cardiac atrial or cardiac ventricular lymphoma involvement.
- Requirement for urgent therapy due to tumor mass effect such as bowel obstruction or blood vessel compression.
- Any medical condition likely to interfere with assessment of safety or how well it works of study treatment.
- Live vaccine ≤6 weeks prior to planned start of conditioning regimen.
- Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning chemotherapy on the fetus or infant.
- Females of childbearing potential and males of child fathering potential who are not willing to practice two methods of birth control from the time of consent through 6 months after infusion of the study drug.
- In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
- Patients who are receiving any other investigational agents.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, 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.