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Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

J

Juventas Cell Therapy

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Non-hodgkin Lymphoma

Treatments

Biological: HY004

Study type

Interventional

Funder types

Industry

Identifiers

NCT06005649
HY004102

Details and patient eligibility

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

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Single dose of HY004
Experimental group
Description:
Patients received a single dose of anti-CD22/CD19 CAR T cells after receiving a conditioning regimen of cyclophosphamide and fludarabine.
Treatment:
Biological: HY004

Trial contacts and locations

0

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Central trial contact

Junyin Yu

Data sourced from clinicaltrials.gov

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