NCT05352828

Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy

Phase 1b Study Evaluating the Safety and Efficacy of Autologous CD30.CAR-T in Combination With PD-1 Checkpoint Inhibitor (Nivolumab) in Relapsed or Refractory Classical Hodgkin Lymphoma Patients After Failure of Frontline Therapy (ACTION)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Tessa Therapeutics · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Upon successful leukapheresis to produce CD30.CAR-T cells, patients will enter the treatment phase of the study. Treatments will include 4 cycles of nivolumab and CD30.CAR-T infusion (preceded by lymphodepletion chemotherapy). Patients will then enter the post-treatment follow-up phase of the study, whereby patients will undergo either autologous stem cell transplant or continue to receive up to 6 additional treatment cycles of nivolumab. Patients will be followed for response assessments and safety monitoring until end of study (EOS); approximately 3 years after leukapheresis. Long-term follow-up will continue with additional safety monitoring and survival for up to 15 years after Leukapheresis.

Conditions

• Classical Hodgkin Lymphoma
• Hodgkin Disease Refractory
• Hodgkin Disease Recurrent

Interventions

Type	Name	Description
DRUG	Nivolumab	Dose: 480 mg or 6 mg/kg Q4W
DRUG	Autologous CD30.CAR-T	Dose: 2 x 10e8 cells/m2
DRUG	Fludarabine	Dose: 30 mg/m2/day x 3 days
DRUG	Bendamustine	Dose: 70 mg/m2/day x 3 days

Timeline

• Start date: 2022-07-25
• Primary completion: 2025-12-15
• Completion: 2037-12-15
• First posted: 2022-04-29
• Last updated: 2023-04-03

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study