JV-394 for T-Cell Lymphoma

Overseen By Sattva S Neelapu, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Antimicrobials

Disqualifiers: CNS lymphoma, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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?

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.

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

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

How Is the Trial Designed?

Group I: Treatment with JV-394 CAR T Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+