Status and phase
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About
This is a multi-center, open-label, single-arm, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma (r/r B-NHL).
Full description
This trial is a multi-center, open label, single-arm, phase I/II trial to evaluate the safety and efficacy of HY004 in Adult(aged 18~75 years old) patients with r/r B-NHL.
The phase I part of the trial is to evaluate the safety, optimal dose of HY004, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Adult patients with r/r B-NHL. The phase II part of the trial is to evaluate the efficacy and safety of HY004 in in the treatment of Adult patients with r/r B-NHL. The study includes screening, pre-treatment (Cell Product manufacture & lymphodepletion), HY004 infusion , safety and efficacy follow-up, and survival follow-up. All subjects who have received HY004 infusion will be followed for up to 2 years.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key Inclusion Criteria:
Patients who are willing to sign the informed consent form;
Aged 18-75 years, male or female;
Previously received≥2nd-line adequate therapy or hematopoietic stem cell transplantation (HSCT), and patients with CD19+/CD22+ relapsed/refractory B-NHL according to the WHO classification 2017, which are provided specifically as follows:
Measurable imaging lesion at screening: Intranodal lesion must have a long diameter of more than 1.5 cm, and extranodal lesion must have a long diameter of more than 1.0 cm with PET-positive disease by Lugano classification .
PET-positive disease BY Lugano classification
Adequate bone marrow, renal, hepatic, pulmonary and cardiac function.
Adequate vascular access for leukapheresis procedure
Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy.
Key Exclusion Criteria:
Active Central Nervous System (CNS) involvement by malignancy.
Patients with existing central nervous system disease or with a history of central nervous system disease.
Patients receiving any of the following drugs or therapies within the specified period prior to apheresis:
Patients previously received CAR-T cell therapy, the products that have same indication and have beenlisted in China are eligible;
Patients who have previously received allogeneic hematopoietic stem cell transplantation (allo-HSCT) within 3 mouths.
Patients with acute graft-versus-host disease (GVHD) or moderate-tosevere chronic GVHD within 4 weeks before screening.
Active systemic autoimmune disease.
Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti- HCV positive).
Patients with active infections at screening.
History of cardiovascular disease.
Pregnant or nursing women.
Primary purpose
Allocation
Interventional model
Masking
0 participants in 1 patient group
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Central trial contact
Junyin Yu
Data sourced from clinicaltrials.gov
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