Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms

NCT07382817 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 2024-1446NCI-2026-00809
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplasms

Keywords

CAR T cell therapy; T Cell Lymphoma; T/NK-Cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Safety and Adverse Events (AEs)

  Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  Through study completion; an average of 1 year

Study Arms (1)

Treatment with JV-394 CAR T

EXPERIMENTAL

Infusion of JV-394 and subsequent safety monitoring will be conducted at a healthcare facility. Participants may be hospitalized for JV-394 infusion and subsequent safety monitoring at the discretion of the investigator or treating physician. JV-394 will be administered as a single infusion of anti-CD94 CAR-transduced autologous T cells on day 0 in under 30 minutes.

Drug: JV-394

Interventions

JV-394 DRUG

Given by infusion

Treatment with JV-394 CAR T

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 panniculitis-like TCL, monomorphic epitheliotropic intestinal TCL, enteropathy-associated TCL, primary cutaneous γδ TCL, peripheral TCL cytotoxic type, Epstein-Barr virus (EBV)+ nodal T/NK cell lymphoma, and other CD94+ T/NK cell malignancies not listed above.
• ≥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.
• 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. Subjects with primary cutaneous variants must have at least 1 measurable lesion that is evaluable using the Olsen 2021 criteria.
• 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.

You may not qualify if:

• Subjects 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 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.
• 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 efficacy 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, unstable angina, or other clinically significant cardiac disease.
• 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.
• 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 skin infections are permitted if responding to active treatment and after consultation with the Principal Investigator.
• 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 and/or nucleic acid testing.
• 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 replacement of corticosteroids of up to 7.5 mg of prednisone or equivalent per day, and topical and inhaled corticosteroids are permitted.
• 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 efficacy of study treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Neoplasms; Lymphoma, T-Cell; Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Sattva S Neelapu, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sattva S Neelapu, MD

CONTACT

(713) 563-3429; sneelapu@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 3, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): December 9, 2029
• Study Completion (Estimated): December 9, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

US (1)