JV-394 for T-Cell Lymphoma

SS
Overseen BySattva S Neelapu, MD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

SS

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

Absolute neutrophil count of ≥1.0×109 /L
Side effects from my previous treatments are mild or gone, except for hair loss.
My tumor has over 50% of cells positive for CD94.
See 15 more

Exclusion Criteria

I am on systemic immunosuppressants for an autoimmune or inflammatory condition.
Patients with tumor cells in the peripheral blood ≥1% of lymphocytes as determined by flow cytometry
History of any form of primary immunodeficiency that in the opinion of the investigator may affect efficacy of the CAR T product
See 17 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single infusion of JV-394 CAR T cells and are monitored for safety

1 day
1 visit (in-person, possible hospitalization)

Safety Monitoring

Participants are monitored for safety and adverse events post-infusion

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Treatment with JV-394 CAR TExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Phase 1 Study of JV-394 Autologous Anti-CD94 CAR T for ...

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pubmed.ncbi.nlm.nih.gov/41601175/

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9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38582666/

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 ...