Actively Recruiting
Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms
Led by M.D. Anderson Cancer Center · Updated on 2026-02-27
33
Participants Needed
1
Research Sites
302 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Confirmed T/NK cell malignancies by local pathology
- Relapsed or refractory disease after at least one systemic therapy or intolerant to standard therapy
- Eligible lymphoma types including extranodal NK/TCL, hepatosplenic TCL, primary cutaneous CD8+ aggressive epidermotropic cytotoxic TCL, subcutaneous panniculitis-like TCL, monomorphic epitheliotropic intestinal TCL, enteropathy-associated TCL, primary cutaneous gamma delta TCL, peripheral TCL cytotoxic type, EBV+ nodal T/NK cell lymphoma, and other CD94+ T/NK cell malignancies
- At least 50% tumor cells positive for CD94 by flow cytometry or immunohistochemistry
- At least two weeks or 5 half-lives since prior systemic therapy or 1 week since radiation before leukapheresis
- ECOG performance status 0-1
- At least one measurable lesion per criteria depending on lymphoma type
- Prior therapy toxicities stable and recovered to grade 1 or less (except non-significant toxicities)
- Absolute neutrophil count ≥1.0 x10^9/L
- Absolute lymphocyte count ≥0.1 x10^9/L
- Platelet count ≥75 x10^9/L
- Creatinine clearance ≥45 mL/min
- Serum ALT/AST ≤5 times upper limit of normal
- Total bilirubin ≤2 mg/dL unless Gilbert's syndrome
- Cardiac ejection fraction ≥45% with no significant pericardial effusion
- Baseline oxygen saturation ≥92% on room air
- Negative pregnancy test for women of childbearing potential
- Women not considered of childbearing potential if hysterectomy or over 45 years with no menstrual period for ≥1 year
You will not qualify if you...
- Aggressive NK cell leukemia and indolent T/NK cell malignancies like TLGL or NK-LGL
- Tumor cells ≥1% of lymphocytes in peripheral blood by flow cytometry
- Active central nervous system lymphoma or brain metastases, unless treated over 1 year ago and no disease on MRI
- Autologous stem cell transplant within 6 weeks
- Allogeneic transplant within 3 months or active graft versus host disease
- Primary immunodeficiency affecting CAR T efficacy
- Recent serious cardiovascular conditions within 6 months
- History of other malignancies unless disease free for ≥2 years or deemed safe by investigator
- Uncontrolled infections requiring IV antimicrobials
- Known HIV, active hepatitis B or C infection unless viral load undetectable
- Active autoimmune or inflammatory disease requiring systemic immunosuppressive therapy (some corticosteroids allowed)
- CNS disorders such as seizures, stroke, dementia, or autoimmune CNS disease
- Cardiac lymphoma involvement
- Urgent need for therapy due to tumor mass effect
- Any medical condition interfering with safety or efficacy assessment
- Live vaccine within 6 weeks before conditioning
- Pregnant or breastfeeding women
- Unwillingness to use birth control methods through 6 months after infusion
- Unlikely to complete study visits or comply with requirements
- Receiving other investigational agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
The University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sattva S Neelapu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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