Status:
ACTIVE_NOT_RECRUITING
Autologous CD30.CAR-T in Combination With Nivolumab in cHL Patients After Failure of Frontline Therapy
Lead Sponsor:
Tessa Therapeutics
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Classical Hodgkin Lymphoma
Hodgkin Disease Refractory
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief 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 inhib...
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 lymp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2037
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05352828
Start Date
July 25 2022
End Date
December 15 2037
Last Update
April 3 2023
Active Locations (5)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
University of Miami
Miami, Florida, United States, 33136
3
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
4
Baylor College of Medicine
Houston, Texas, United States, 77030