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CAR T-cell Therapy

CAR-T + Nivolumab for Hodgkin Lymphoma (ACTION Trial)

Phase 1

Waitlist Available

Led By Helen Heslop, MD

Research Sponsored by Tessa Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy

Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, or equivalent either Karnofsky performance status (for patients ≥ 16 years of age) or Lansky performance status (for patients < 16 years of age)

Must not have

History of a significant irAE from prior immune checkpoint inhibitor therapy

Active second malignancy or history of another malignancy within the last 3 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 3 years from leukapheresis

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for Hodgkin lymphoma that has failed standard treatment. The goal is to see if it is safe and effective.

Who is the study for?

This trial is for patients aged 12+ with classical Hodgkin lymphoma (cHL) that didn't respond to standard treatments. They must have at least one lesion visible on PET-CT scans, good organ function, and a performance status indicating they can carry out daily activities with little or no assistance.

What is being tested?

The study tests a combination therapy of CD30.CAR-T cells and Nivolumab in cHL patients who haven't had success with first-line therapies. It's an early-phase trial assessing the safety and potential effectiveness of this new treatment approach.

What are the potential side effects?

Possible side effects include immune system reactions, infusion-related symptoms, fatigue, changes in blood counts leading to increased infection risk or bleeding tendencies, liver or kidney function alterations, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Hodgkin lymphoma has returned or didn't respond to initial chemotherapy.

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

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I do not have any active infections, including COVID-19.

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I have at least one cancer lesion visible on a PET-CT scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a serious side effect from previous immunotherapy.

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I have not had another cancer in the past 3 years.

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I am not currently receiving any live vaccines.

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I have had a stem cell transplant for my Hodgkin lymphoma.

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I do not have any ongoing serious bleeding issues.

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I have had an autoimmune disease in the last 5 years.

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I have lung disease that causes symptoms or could affect lung-related side effects from treatment.

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I am currently taking drugs that suppress my immune system or long-term steroids.

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I have no major side effects from previous treatments.

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I am allergic or have had bad reactions to nivolumab, fludarabine, or bendamustine.

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My lymphoma has spread to my brain or spinal cord.

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My oxygen levels are below 90% without assistance.

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I have severe heart problems that limit my daily activities.

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My heart's pumping ability is below normal.

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I do not have active seizures, stroke, brain bleeding, dementia, cerebellar disease, or autoimmune disease affecting my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 3 years from leukapheresis

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 3 years from leukapheresis

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 years from leukapheresis for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of autologous CD30.CAR-T in combination with nivolumab

Secondary study objectives

Anti-tumor activity using CR rate of autologous CD30.CAR-T in combination with nivolumab

Duration of response

Overall response rate

+1 more

Other study objectives

Overall survival

Pharmacokinetics - Area under the curve

Pharmacokinetics - Maximum concentration (Cmax)

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Nivolumab and CD30.CAR-TExperimental Treatment4 Interventions

Study treatment will include 4 cycles of nivolumab and a single CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy of Fludarabine and Bendamustine).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2015

Completed Phase 3

~4010

Fludarabine

2012

Completed Phase 4

~1830