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

• Status: Not yet recruiting
• Trial end date: 2037-12-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tessa Therapeutics
• Collaborator: Bristol-Myers Squibb
• Treatments: Bendamustine Hydrochloride; Fludarabine; Nivolumab

Criteria

Inclusion Criteria:

1. Signed ICF

2. Male or female patients who are 12 years of age and above

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

4. At least 1 lesion, which must be fluordeoxyglucose positron emission tomography (FDG-PET) avid and measurable by PET-CT scan

5. Adequate laboratory parameters including hematologic, renal, hepatic, and coagulation function

6. 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)

7. Anticipated life expectancy > 12 weeks

8. No active infections including COVID 19 at Screening

Exclusion Criteria:

1. Evidence of lymphomatous involvement of the central nervous system (CNS)

2. 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

3. Symptomatic cardiovascular disease: Class III or IV according to the New York Heart Association (NYHA) Functional Classification

4. Active uncontrolled bleeding or a known bleeding diathesis

5. Inadequate pulmonary function defined as oxygen saturation by pulse oximetry < 90% on room air

6. Echocardiogram (ECHO) or Multi-gated Acquisition (MUGA) scan with left ventricular ejection fraction (LVEF) < 45%

7. Prior receipt of salvage therapy, for relapsed or refractory cHL, including allogeneic or ASCT

8. Prior receipt of investigational CD30.CAR-T cells

9. Receiving any investigational agents or any tumor vaccines

10. Receiving any live/attenuated vaccines

11. Ongoing treatment with immunosuppressive drugs or chronic systemic corticosteroids

12. Unresolved > Grade 1 non-hematologic toxicity associated with any prior treatments

13. Previous history of known or suspected autoimmune disease within the past 5 years

14. Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity

15. Evidence of human immunodeficiency virus (HIV) infection

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

17. Evidence of active viral infection with hepatitis C virus (HCV)

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

19. History of hypersensitivity reactions to murine protein-containing products or other product excipients

20. Any allergic or adverse reaction to nivolumab, fludarabine, or bendamustine that precludes treatment with these agents

21. History of a significant irAE from prior immune checkpoint inhibitor therapy