JV-394 for T-Cell Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine the highest safe dose of JV-394, a type of CAR-T cell therapy, for individuals with T/NK cell lymphoma that hasn't responded to other treatments. Researchers will also examine the treatment's safety and potential side effects. It suits those with T/NK cell lymphoma who have not found success with other treatments or cannot tolerate standard options. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, it mentions that at least two weeks or 5 half-lives must have passed since any prior systemic anti-cancer therapy before starting the trial, which might imply a need to pause certain treatments. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that JV-394 is likely to be safe for humans?
Research has shown that CAR T-cell therapy improves outcomes for various cancers, including lymphoma. This treatment can be effective, but it may also carry some risks. Common side effects include fever, low blood cell counts, and tiredness, which are usually manageable with medical care.
For JV-394, a specific CAR T-cell therapy targeting T/NK cell lymphoma, early trials focus on finding the safest dose. Specific data on JV-394 remains limited, but the primary goal in this early trial phase is to understand its safety. Similar therapies have reported some serious side effects, but these are often temporary and treatable.
CAR T-cell therapies like JV-394 continue to be studied, showing promise for patients with hard-to-treat cancers. Discussing potential risks and benefits with a doctor is important if considering joining a trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for T-cell lymphoma, which typically involve chemotherapy, immunotherapy, or radiation, JV-394 offers a novel approach by using CAR T-cell therapy. This treatment is unique because it involves engineering a patient's own T cells to express a CAR (chimeric antigen receptor) that specifically targets CD94, a molecule often found on lymphoma cells. The engineered T cells are then infused back into the patient to seek out and destroy cancer cells more precisely. Researchers are excited about JV-394 because it has the potential for a more targeted attack on cancer cells with fewer side effects, offering a promising alternative for patients who have not responded well to conventional therapies.
What evidence suggests that JV-394 might be an effective treatment for T-cell lymphoma?
Research has shown that CAR-T cell therapies hold promise for treating blood cancers that resist standard treatments. One study found that 52% of patients with relapsed or hard-to-treat lymphoma achieved complete remission with a new CAR-T therapy. This trial will evaluate JV-394, a CAR-T cell therapy made from a patient's own cells and targeting CD94, to assess its effectiveness for patients with relapsed or hard-to-treat T/NK cell lymphoma. CAR-T cells are specially modified to better locate and attack cancer cells, and they have succeeded in similar cases. These results are encouraging, but further research is needed to confirm the effectiveness of JV-394.16789
Who Is on the Research Team?
Sattva S Neelapu, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with T/NK cell lymphoma that's come back or hasn't responded to treatment. They need a certain type of immune cell (CD94+) in their tumors, decent blood counts, and good organ function. People can't join if they have autoimmune diseases needing strong meds, recent heart issues, active infections requiring IV drugs, HIV/hepatitis B/C, CNS lymphoma, or are pregnant/breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single infusion of JV-394 CAR T cells and are monitored for safety
Safety Monitoring
Participants are monitored for safety and adverse events post-infusion
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JV-394
Trial Overview
JV-394 is being tested to find the highest dose patients can tolerate without severe side effects. It's an autologous CAR-T therapy where a patient's own immune cells are modified to fight cancer and then put back into their body.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
Citations
Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for ...
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 ...
CAR-T cell therapy: developments, challenges and expanded ...
Furthermore, CAR-T cell therapy has shown enhanced effectiveness in addressing cancer types that are challenging to treat with more traditional cancer therapies ...
3.
pennmedicine.org
pennmedicine.org/news/enhanced-car-t-cell-therapy-offers-new-strategy-for-lymphomaEnhanced CAR T cell therapy offers new strategy for ...
A phase I study of a next-generation CAR T cell therapy showed a 52 percent complete remission rate for patients with relapsed/refractory lymphoma.
CAR T-Cell-Based gene therapy for cancers
CAR T-cell therapies have shown significant promise in the treatment of hematologic malignancies in recent years (57–61), although the first insight into their ...
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OBJECTIVE: To evaluate the safety, efficacy, and practical considerations of the 4 US Food and Drug Administration–approved CAR T-cell therapies for the ...
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Long-term follow-up has confirmed the curative potential of CAR T-cell therapy in relapsed or refractory LBCL. Toxicities are generally ...
December 2025 - January 2026: What's New in Myeloma?
CAR-T cell therapy is an advanced treatment that has greatly improved outcomes for people with multiple myeloma whose disease has come back ...
Patient-Reported Outcomes of CAR T-Cell Therapy in Non- ...
Chimeric antigen receptor T-cell (CAR-T) therapy has significantly improved outcomes for patients with non-Hodgkin lymphoma (NHL), but not all patients ...
Safety and Toxicity Profiles of CAR T Cell Therapy in Non- ...
Background: The application of CD19-directed chimeric antigen receptor T (CAR T) cell therapy has improved outcomes for thousands of patients with non-Hodgkin B ...
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