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

Autologous CD30.CAR-T

Bendamustine

Helen Heslop, MD

Sairah Ahmed, MD

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.

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.

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)

Time to peak concentration of CD30.CAR-T in the blood

Area under the curve of CD30.CAR-T in the blood

Bristol-Myers Squibb

Tessa Therapeutics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy	NCT05352828	Classical Hodgk... Hodgkin Disease... Hodgkin Disease...	Nivolumab Autologous CD30... Fludarabine Bendamustine	12 Years -	Tessa Therapeutics
Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy	NCT05352828	Classical Hodgk... Hodgkin Disease... Hodgkin Disease...	Nivolumab Autologous CD30... Fludarabine Bendamustine	12 Years -	Tessa Therapeutics

Spots Global Cancer Trial Database for hodgkin disease refractory