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

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen BySairah Ahmed, M.D.

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Tessa Therapeutics

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a Phase 1b, multicenter, open-label, single arm study to evaluate the safety and efficacy of the combination therapy, CD30.CAR-T and the programmed cell death protein-1 (PD-1) checkpoint inhibitor, nivolumab, in patients aged 12 years of age and above with relapsed or refractory classical Hodgkin lymphoma (cHL) following failure of standard frontline therapy.

Eligibility Criteria

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.

Inclusion Criteria

Anticipated life expectancy > 12 weeks

Signed ICF

My blood, kidney, liver, and clotting tests are within normal ranges.

+5 more

Exclusion Criteria

I had a serious side effect from previous immunotherapy.

You are not currently taking any experimental drugs or tumor vaccines.

Evidence of active viral infection with hepatitis B virus (HBV)

+18 more

Participant Groups

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.

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).