Axicabtagene Ciloleucel for Non-Hodgkin's Lymphoma

(ZUMA-5 Trial)

Recruiting at 18 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Kite, A Gilead Company

Disqualifiers: Transformed FL, Small lymphocytic, 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

Duration: 1-2 weeks

159 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will enroll approximately 160 adult participants who have relapsed or refractory (r/r) iNHL to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. Axicabtagene ciloleucel is made from the participants own white blood cells which are genetically modified and grown to fight cancer. An objective response rate of 70% is targeted.

Research Team

Kite Study Director

Principal Investigator

Kite, A Gilead Company

Eligibility Criteria

Adults with relapsed or refractory indolent Non-Hodgkin Lymphoma, specifically follicular lymphoma or marginal zone lymphoma that worsened after at least two prior treatments. Participants must have measurable disease, no CNS lymphoma involvement, and be able to stop current therapies before leukapheresis. They should be in good physical condition (ECOG 0-1) and not pregnant or breastfeeding.

Inclusion Criteria

My lymphoma has not affected my brain or spinal cord.

Individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (CAR) T cell infusion (both male and female individuals)

My lymphoma has worsened after two or more treatments.

Exclusion Criteria

My cancer is classified as Grade 3b follicular lymphoma.

My lymphoma has changed from a less aggressive type to a more aggressive one.

My lymphoma affects my heart or I need urgent cancer treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis

Participants undergo leukapheresis to collect white blood cells for manufacturing

1 week

Conditioning Chemotherapy

Participants receive conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days

1 week

Treatment

Participants are infused with axicabtagene ciloleucel and monitored in a hospital for a minimum of 7 days

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24-60 months

Long-term Follow-up

Participants transition to a long-term follow-up study for the remainder of the 15-year follow-up assessments

Up to 15 years

Treatment Details

Interventions

• Axicabtagene Ciloleucel
• Cyclophosphamide
• Fludarabine

Trial Overview The trial is testing axicabtagene ciloleucel, a treatment made from the patient's own genetically modified white blood cells designed to fight cancer. It also involves pre-treatment with Cyclophosphamide and Fludarabine. The goal is to see if this approach is effective (aiming for a 70% response rate) and safe for patients.

Participant Groups

Group I: axicabtagene ciloleucel Experimental Treatment 3 Interventions

Participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide, followed by a single infusion of CAR transduced autologous T cells.

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?

Kite, A Gilead Company

Lead Sponsor

Trials

45

Recruited

4,300+