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Editorial · CASRAI · clinical-research

MD Anderson Launches Phase 1 Trial of CD94-Targeted CAR-T Therapy for T/NK-Cell Lymphoma

MD Anderson has opened a Phase 1 trial of JV-394, a CAR-T therapy targeting CD94, in patients with relapsed or refractory T-cell and NK-cell lymphomas, a cancer type that has long resisted cell-based immunotherapy.

Published 9 Aug 2026· Last updated 24 Aug 2026· 3 minute read

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MD Anderson Cancer Center has opened a Phase 1 clinical trial testing a CAR-T cell therapy engineered to target CD94, a marker found on a group of blood cancers that have long been considered nearly untouchable by cell-based immunotherapy: T-cell and NK-cell lymphomas.

The trial, registered on ClinicalTrials.gov as NCT07382817, is evaluating JV-394, an autologous anti-CD94 chimeric antigen receptor (CAR) T-cell therapy, in patients with relapsed or refractory CD94-positive T/NK-cell neoplasms. The study opened February 18, 2026, is currently recruiting, and is sponsored by The University of Texas MD Anderson Cancer Center. MD Anderson’s own announcement, published May 15, 2026, describes the therapy as targeting “CD94+ relapsed or refractory T/NK cell lymphomas.”

Why T/NK-cell lymphoma has resisted CAR-T therapy

CAR-T therapy has produced durable remissions in some B-cell blood cancers by engineering a patient’s own T cells to recognize and destroy tumor cells carrying a specific surface marker. Extending that success to T-cell and NK-cell lymphomas has proven far harder. The core obstacle is a target-selection problem: many of the surface markers that define malignant T- and NK-cells are also expressed on the healthy T cells that manufacturers need to engineer into the CAR-T product in the first place, and on normal T cells elsewhere in the body that the immune system needs to fight infection. A CAR-T therapy built against such a marker risks attacking its own starting material during manufacturing (a problem researchers in the field call fratricide) or depleting the healthy immune repertoire it is delivered into. This is the same design challenge that has shaped other T-cell-malignancy CAR-T programs targeting markers such as CD5 and CD7, and it is the backdrop against which a CD94-directed approach is being tested.

CD94 is a receptor expressed on natural killer cells and a subset of cytotoxic T cells, and it is present on the malignant cells in a number of T/NK-cell lymphoma subtypes. Targeting it therapeutically is being explored as a way to reach a disease category where standard chemotherapy regimens frequently fail and outcomes remain poor, particularly for aggressive subtypes.

What the trial covers, and what it doesn’t yet show

Per its ClinicalTrials.gov registration, the study is a Phase 1 dose-finding safety and efficacy trial with an estimated enrollment of 33 participants, and a listed primary completion date of December 2029. Its stated purpose is to determine the highest safe dose of JV-394 while monitoring for side effects and early signs of anti-tumor activity in patients with T/NK-cell lymphoma subtypes that have already returned or stopped responding to treatment, including extranodal NK/T-cell lymphoma and hepatosplenic T-cell lymphoma. JV-394 is administered as a single infusion.

It is worth being precise about what a trial at this stage can and cannot tell us. A Phase 1 study is designed first to answer safety questions, not to establish that a therapy works. Any early reports of tumor responses in a small, open-label, dose-escalation cohort are not the same as evidence of a proven treatment, and a therapy that clears Phase 1 safety hurdles can still fail to show benefit, or reveal new safety signals, in larger later-phase trials. For a patient population with historically limited options, that distinction matters as much as the scientific novelty of the approach itself.

Why it’s a story worth tracking

Regardless of eventual outcome, the trial is notable as one of the first efforts to bring a CAR-T construct specifically engineered around the fratricide problem into human testing for T/NK-cell lymphoma, a disease category where cell therapy has been notably absent from the treatment landscape that reshaped outcomes in B-cell malignancies. Research administrators and IRB/ethics staff tracking early-phase oncology cell-therapy protocols may find this trial a useful reference point for how sponsors are structuring dose-escalation designs around antigen-sharing risk in T-cell-directed CAR constructs.

Related: 3+3 dose escalation. A statistical comparison of the 3+3 rule-based dose-escalation design and the model-based Continual Reassessment Method (CRM) used to find the maximum tolerated dose in Phase 1 oncology trials.

Primary sources: NCT07382817, ClinicalTrials.gov; MD Anderson Cancer Center newsroom, “Novel CAR T cell therapy developed by UT MD Anderson researchers moves into clinical studies,” May 15, 2026.

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