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Trial Title:
Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
NCT ID:
NCT06005649
Condition:
Non-hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Conditions: Keywords:
HY004
CD22/CD19 Chimeric Antigen Receptor T-cells
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
HY004
Description:
Autologous 2nd generation bispecific CAR-T cells targeting both CD22 and CD19, single
infusion intravenously.
Start Dose level: 2.00 x 10^6/kg CAR+T-cells
Arm group label:
Single dose of HY004
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 B-NHL).
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 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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Patients who are willing to sign the informed consent form;
2. Aged 18-75 years, male or female;
3. 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:
1. Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);
2. Primary mediastinal large B cell lymphoma (PMBCL);
3. Grade 3b follicular lymphoma;
4. Transformed follicular lymphoma;
5. High grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, and
high grade B cell lymphoma - not otherwise specified.
4. 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 .
5. PET-positive disease BY Lugano classification
6. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function.
7. Adequate vascular access for leukapheresis procedure
8. 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:
1. Active Central Nervous System (CNS) involvement by malignancy.
2. Patients with existing central nervous system disease or with a history of central
nervous system disease.
3. Patients receiving any of the following drugs or therapies within the specified
period prior to apheresis:
1. Alemtuzumab and Bendamustine within 6 months prior to apheresis;
2. Cladribine within 3 months prior to apheresis;
3. Lenalidomide within 1 mouth prior to apheresis;
4. Lymphocytotoxic chemotherapy within 2 weeks prior to apheresis - use in more
than 3 half-lives prior to apheresis is eligible;
5. Anti-CD20 monoclonal antibody and therapeutic dose of hormones within 7 d prior
to apheresis;
6. Non-lymphocytotoxic chemotherapy within 7 d prior to apheresis - use in more
than 3 half-lives prior to apheresis is eligible;
7. Venetoclax (BCL-2 inhibitor) within 4 d prior to apheresis;
8. Idelalisib (PI3Kδ kinase inhibitor) within 2 d prior to apheresis;
9. DLI within 6 weeks prior to apheresis;
10. Radiotherapy within 6 weeks prior to apheresis - progressive disease at
radiotherapy site, or PET positive lesion at other non-radiotherapy site is
eligible;
4. Patients previously received CAR-T cell therapy, the products that have same
indication and have beenlisted in China are eligible;
5. Patients who have previously received allogeneic hematopoietic stem cell
transplantation (allo-HSCT) within 3 mouths.
6. Patients with acute graft-versus-host disease (GVHD) or moderate-tosevere chronic
GVHD within 4 weeks before screening.
7. Active systemic autoimmune disease.
8. Known infection with human immunodeficiency virus (HIV) or chronic infection with
hepatitis B virus (HbsAg positive) or hepatitis C virus (anti- HCV positive).
9. Patients with active infections at screening.
10. History of cardiovascular disease.
11. Pregnant or nursing women.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
August 31, 2024
Completion date:
September 2026
Lead sponsor:
Agency:
Juventas Cell Therapy Ltd.
Agency class:
Industry
Source:
Juventas Cell Therapy Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06005649
