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Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for r/r CD94+ T/NK Cell Neoplasms | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

A Phase 1 Safety and Efficacy Study of JV-394 Autologous Anti-CD94 Chimeric Antigen Receptor T Cell Therapy in Patients With Relapsed or Refractory CD94+ T/NK Cell Neoplasms

NCT07382817•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

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.

Detailed Description

Primary Objective: The primary objective is to determine the safety and identify the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of JV-394 in patients with CD94+ r/r T/NK cell malignancies. Secondary Objective: The secondary objectives are to determine the efficacy in adults with r/r CD94+ T/NK cell malignancies at the MTD or RP2D of JV-394. Secondary end points include overall response rate (ORR; including CR+PR) and CR rate as defined by Lugano or Olsen Criteria, duration of response (DOR), progression free survival (PFS) and overall survival (OS).41,42 Exploratory Objective: The exploratory objectives are to assess the cellular kinetics and pharmacodynamic effects of JV-394 anti-CD94 CAR T cell product and to evaluate biomarkers associated with response, resistance, and toxicity after administration of CAR T product in blood and tumor samples.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. ≥18 years of age.
•2. Confirmed T/NK cell malignancies as per local histopathological assessment.
•3. Relapsed or refractory disease after at least one line of systemic therapy or intolerant to standard therapy for their cancer.
•4. 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.
•5. ≥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.
•6. 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.
•7. ECOG performance status of 0-1 (Appendix 1).
•8. 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.
•9. Toxicities due to prior therapy must be stable and recovered to ≤grade 1 (except for clinically non-significant toxicities such as alopecia).
•10. Absolute neutrophil count of ≥1.0×109 /L.
+25 more criteria

Exclusion Criteria

•1. Subjects with aggressive NK cell leukemia and indolent T/NK cell malignancies such as TLGL or NK-LGL.
•2. Patients with tumor cells in the peripheral blood ≥1% of lymphocytes as determined by flow cytometry.

Locations (1)

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

February 18, 2026

Primary Completion Date

December 9, 2029

Completion Date

December 9, 2031

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Neoplasms

Interventions

JV-394

DRUG

Contacts

Sattva S Neelapu, MD

CONTACT

(713) 563-3429 sneelapu@mdanderson.org

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease

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