Status:
WITHDRAWN
Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Lead Sponsor:
Juventas Cell Therapy Ltd.
Conditions:
Non-hodgkin Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed 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 tr...
Eligibility Criteria
Inclusion
- Key
- 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:
- Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);
- Primary mediastinal large B cell lymphoma (PMBCL);
- Grade 3b follicular lymphoma;
- Transformed follicular lymphoma;
- High grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and high grade B cell lymphoma - not otherwise specified.
- 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
- 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:
- Alemtuzumab and Bendamustine within 6 months prior to apheresis;
- Cladribine within 3 months prior to apheresis;
- Lenalidomide within 1 mouth prior to apheresis;
- Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
- Anti-CD20 monoclonal antibody and therapeutic dose of hormones within 7 d prior to apheresis;
- Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more than 3 half-lives prior to apheresis is eligible;
- Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;
- Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;
- DLI within 6 weeks prior to apheresis;
- Radiotherapy within 6 weeks prior to apheresis - progressive disease at radiotherapy site, or PET positive lesion at other non-radiotherapy site is eligible;
- 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.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2027
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06005649
Start Date
September 1 2025
End Date
June 1 2027
Last Update
August 8 2025
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