Anakinra for Neurotoxicity Prevention in CAR-T Cell Therapy

Recruiting at 1 trial location

Overseen By Matt J Frigault, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Marcela V. Maus, M.D.,Ph.D.

Must not be taking: Aminoglycosides, Antimicrobials, others

Disqualifiers: Malignancy, CNS disorder, Cardiac disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This research study is studying the combination of anakinra and axicabtagene ciloleucel to reduce the occurrence of the side effects Cytokine Release Syndrome (CRS) and neurologic toxicities with relapsed or refractory Non-Hodgkin lymphoma (NHL). * Relapsed NHL is the condition of returned Non-Hodgkin lymphoma. * Refractory NHL is the condition of previous treatment resistant Non-Hodgkin lymphoma. * Cytokine Release Syndrome (CRS) is a group of side effect symptoms that can include nausea, headache, rapid heartbeat, shortness of breath, kidney damage, and rash. * Neurologic toxicity is nervous system disorder characterized by confusion This research study involves two drugs: * Anakinra * Axicabtagene Ciloleucel.

Research Team

Matt Frigault, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with relapsed or resistant large B-cell lymphoma after two prior therapies. They must have at least one measurable lesion, stable recovery from previous treatments, good organ function, and no severe allergies to study drugs. Women of childbearing age need a negative pregnancy test and agree to use contraception.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My side effects from previous treatments are mild or gone.

My large B-cell lymphoma has not responded to at least two treatments.

Exclusion Criteria

I do not have any severe or uncontrolled infections.

Any medical condition likely to interfere with assessment of safety or efficacy of study treatment

I might need urgent cancer treatment soon due to a serious risk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Enrollment/Leukapheresis

Participants undergo leukapheresis to collect cells for CAR-T cell manufacturing

2-4 weeks

Bridging Therapy

Participants may receive bridging therapy if applicable

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CAR-T cell infusion

1 week

Investigational Product Treatment

Participants receive Anakinra and Axicabtagene Ciloleucel

Post Treatment Assessment

Participants are assessed for neurotoxicity and other adverse events

30 days

Long Term Follow-up

Participants are monitored for progression-free survival and overall survival

24 months

Treatment Details

Interventions

• Anakinra
• Axicabtagene Ciloleucel

Trial Overview The study tests if anakinra can reduce side effects like Cytokine Release Syndrome (CRS) and neurologic toxicities in patients receiving axicabtagene ciloleucel for Non-Hodgkin lymphoma. It's seeing if this combination is safer than the current treatment.

Participant Groups

Group I: Anakinra and Axicabtagene Ciloleucel Experimental Treatment 2 Interventions

Patients who meet eligibility criteria for the study will subsequently be enrolled for treatment. * Screening * Enrollment/Leukapheresis period * Bridging therapy (if applicable) * Lymphodepleting chemotherapy period * Investigational Product (IP) treatment period * Anakinra * Axicabtagene Ciloleucel * Post treatment assessment period * Long term follow-up period

Axicabtagene Ciloleucel is already approved in United States, European Union for the following indications:

Approved in United States as Yescarta for:

• Large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy
• Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
• Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy

Approved in European Union as Yescarta for:

• Diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL) that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy
• Relapsed or refractory DLBCL and primary mediastinal large B-cell lymphoma, after two or more lines of systemic therapy
• Relapsed or refractory follicular lymphoma after three or more lines of systemic therapy

Who Is Running the Clinical Trial?

Marcela V. Maus, M.D.,Ph.D.

Lead Sponsor

Trials

6

Recruited

110+

Kite, A Gilead Company

Industry Sponsor

Trials

45

Recruited

4,300+