AzTrials
AzTrials

Non-hodgkin LymphomaPhase 1/2NCT06005649

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

A Phase 1/2 study testing HY004 in people with Non-hodgkin Lymphoma, run by Juventas Cell Therapy Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-hodgkin Lymphoma
What is being tested?
HY004
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Sep 2025to Jun 2027
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 13Show fewer
  • 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.

Who cannot join

  • 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;
Show all 21Show fewer
  • 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.

About this study

Official title: A Multi-center, Open Label, Single-arm, Phase I/II Clinical Trial of HY004 Cell Injection in the Treatment of Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

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).

Read the 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.

Being tested
HY004
Keywords
HY004, CD22/CD19 Chimeric Antigen Receptor T-cells
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HY004Biological

    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

Study groups in NCT06005649
Study groupRoleWhat they receive
Single dose of HY004ExperimentalPatients received a single dose of anti-CD22/CD19 CAR T cells after receiving a conditioning regimen of cyclophosphamide and fludarabine.
Receives: Biological: HY004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 【Phase I】Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D)

    Determine the MTD and DLT of HY004 in the Treatment and recommend the dose for Phase II study.

    Measured: 28 days

  2. 【Phase II】Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)

    Efficacy of HY004 as measured by ORR at 3 months after HY004 Cell Injection infusion, which includes CR and PR.

    Measured: 3 months

Secondary outcomes (10)

  1. 【Phase I】Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)

    Efficacy of HY004 as measured by ORR at 3 months after HY004 Cell Injection infusion, which includes CR and PR.

    Measured: 3 months

  2. Safety of CNCT19 therapy: CTCAE v5.0

    Safety measures include adverse events as assessed by CTCAE v5.0.

    Measured: 24 months

  3. Complete Remission Rate (CRR)

    Efficacy of HY004 as measured by CR at 3 months after HY004 Cell Injection infusion.

    Measured: 3 months

  4. ORR（CR+PR）/CRR

    Efficacy of HY004 as measured by ORR/CRR at 28 days after cell infusion.

    Measured: 28 days

  5. ORR（CR+PR）/CRR

    Efficacy of HY004 as measured by ORR/CRR at 6 months after cell infusion.

    Measured: 6 months

  6. Best Overall Response (BOR)

    The best overall response after HY004 infusion.

    Measured: 24 mouths

  7. Duration of Remission (DOR)

    DOR means the duration from reaching the response (e.g., CR or PR) criteria of the therapy to the first, clearly defined progressive disease, or death for disease under investigation.

    Measured: 24 mouths

  8. Progression-free survival (PFS)

    PFS means duration from the HY004 Cell Injection infusion to progression of lymphoma, or death for any reason.

    Measured: 24 mouths

  9. Event-free survival (EFS)

    EFS means duration from the HY004 Cell Injection infusion to progression of lymphoma, start of new anti-cancer treatment, relapse, death of any cause or discontinued due to any adverse events.

    Measured: 24 mouths

  10. Overall survival (OS)

    OS is defined as the time from the signing of informed consent form to the date of the last survival follow-up or death due to any cause.

    Measured: 24 mouths

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2023
  2. Study startSep 2025 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Why it stopped: Sponsor changed product development plan

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06005649
Sponsor's protocol ID
HY004102
Status last verified
Aug 2025
First submitted
17 Aug 2023
Last updated
8 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing HY004 in people with Non-hodgkin Lymphoma, run by Juventas Cell Therapy Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

【Phase I】Maximum Tolerated Dose (MTD), Dose Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06005649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in