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

  • STATUS
    Recruiting
  • End date
    Dec 15, 2037
  • participants needed
    15
  • sponsor
    Tessa Therapeutics
Updated on 10 July 2022

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.

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.

Details
Condition Classical Hodgkin Lymphoma, Hodgkin Disease Refractory, Hodgkin Disease Recurrent
Treatment Fludarabine, Nivolumab, Bendamustine, Autologous CD30.CAR-T
Clinical Study IdentifierNCT05352828
SponsorTessa Therapeutics
Last Modified on10 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed ICF
Male or female patients who are 12 years of age and above
Relapsed or refractory CD30+ cHL following failure of a standard frontline chemotherapy
At least 1 lesion, which must be fluordeoxyglucose positron emission tomography (FDG-PET) avid and measurable by PET-CT scan
Adequate laboratory parameters including hematologic, renal, hepatic, and coagulation function
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)
Anticipated life expectancy > 12 weeks
No active infections including COVID 19 at Screening

Exclusion Criteria

Evidence of lymphomatous involvement of the central nervous system (CNS)
Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement
Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification
Active uncontrolled bleeding or a known bleeding diathesis
Inadequate pulmonary function defined as oxygen saturation by pulse oximetry < 90% on room air
Echocardiogram (ECHO) or Multi-gated Acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) < 45%
Prior receipt of salvage therapy, for relapsed or refractory cHL, including allogeneic or ASCT
Prior receipt of investigational CD30.CAR-T cells
Receiving any investigational agents or any tumor vaccines
Receiving any live/attenuated vaccines
Ongoing treatment with immunosuppressive drugs or chronic systemic corticosteroids
Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments
Previous history of known or suspected autoimmune disease within the past 5 years
Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
Evidence of human immunodeficiency virus (HIV) infection
Evidence of active viral infection with hepatitis B virus (HBV)
Evidence of active viral infection with hepatitis C virus (HCV)
Active second malignancy or history of another malignancy within the last 3 years
History of hypersensitivity reactions to murine protein-containing products or other product excipients
Any allergic or adverse reaction to nivolumab, fludarabine, or bendamustine that precludes treatment with these agents
History of a significant irAE from prior immune checkpoint inhibitor therapy
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note