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

NCT06005649 | Withdrawn Phase 1 DMC

• 1 other identifier: HY004102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 B-NHL).

Conditions

Non-hodgkin Lymphoma

Keywords

HY004; CD22/CD19 Chimeric Antigen Receptor T-cells

Outcome Measures

Primary Outcomes (2)

• 【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.

  28 days

• 【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.

  3 months

Secondary Outcomes (10)

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

  3 months

• Safety of CNCT19 therapy: CTCAE v5.0

  24 months

• Complete Remission Rate (CRR)

  3 months

• ORR（CR+PR）/CRR

  28 days

• ORR（CR+PR）/CRR

  6 months

Other Outcomes (3)

• In vivo cellular Pharmacokinetic (PK) profile of HY004.

  24 mouths

• In vivo cellular pharmacodynamics (PD) profile of HY004.

  3 mouths

• Prevalence and incidence of humoral immunogenicity to HY004.

  24 mouths

Study Arms (1)

Single dose of HY004

EXPERIMENTAL

Patients received a single dose of anti-CD22/CD19 CAR T cells after receiving a conditioning regimen of cyclophosphamide and fludarabine.

Biological: HY004

Interventions

HY004 BIOLOGICAL

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

Single dose of HY004

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Juventas Cell Therapy Ltd.: lead

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2023
• First Posted: August 22, 2023
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share