JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma

September 17, 2023 updated by: Qing Zhang, Guangdong Second Provincial General Hospital

Early Exploratory Clinical Study of the Safety, Tolerability and Initial Efficacy of JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell lymphoma

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a single-center, single-arm, open-treatment clinical study. In this study, approximately 10-20 adult and elderly patients with CD19-positive relapsed or refractory B-cell lymphoma will be enrolled for JY231 infusion therapy. The safety of JY231 was evaluated by observing adverse events after cell therapy. Evaluate the effectiveness of JY231 treatment compared to the results of the subjects' own previous standard treatment regimens or base data. Blood, bone marrow, and cerebrospinal fluid were collected before and 12 months after the JY231 infusion to detection.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510317
        • Recruiting
        • Guangdong Second Provincial General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. understand and sign the informed consent and are willing and able to comply with all test requirements;
  2. Age 18-75 years old, gender is not limited;
  3. Flow cytometry or malignant tumor cells were CD19 positive;
  4. Meet the clinical criteria for r/r B-cell lymphoma, including: indolent lymphoma (iNHL), follicular lymphoma (FL) and marginal zone lymphoma (MZL); Invasive B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-lymphocyt-rich large B-cell lymphoma (TCRBCL);
  5. There is at least one measurable lesion on imaging (Lugano 2014 criteria), that is, a lymph node lesion with a diameter greater than 15 mm on CT cross-sectional images or an extranodal lesion with a diameter greater than 10 mm, with a positive FDG-PET test.
  6. Expected survival ≥12 weeks;
  7. The ECOG (Eastern Tumor Collaboration Group) score at baseline was 0 ~ 1;

  8. Adequate organ function (indicators involving liver and kidney function can be appropriately relaxed) :

    • ALT ≤3 xULN;
    • AST)≤3x ULN;
    • Total bilirubin ≤1.5 x ULN;
    • Serum creatinine ≤ 1.5x ULN, or creatinine clearance ≥60 mL/min;
    • Indoor oxygen saturation ≥92%;
    • Left ventricular ejection fraction (LVEF) ≥55%, echocardiography confirmed no pericardial effusion, no clinically significant ECG findings;
    • No clinically significant pleural effusion;

  9. Sufficient who with adequate bone marrow reserve, defined as:

    Absolute neutrophil count (ANC) > 1.000 /mm3; Absolute lymphocyte count (ALC) ≥300 /mm3; Platelet ≥50.000 /mm3; Hemoglobin > 8.0g/dl;

  10. Using the following drugs must meet the following conditions:

    • Steroids: Therapeutic doses of steroids must be discontinued 72 hours before JY231 infusion. Physiological replacement doses of steroids are permitted;
    • Immunosuppression: Any immunosuppressive drug must be stopped ≥4 weeks prior to enrollment;
    • Anti-proliferative therapy other than lympho-depleting chemotherapy within two weeks of infusion; CD20 antibody therapy must be discontinued within 4 weeks prior to infusion or 5 half-lives (whichever is older);
    • CNS disease prevention must be stopped 1 week before JY231 infusion (e.g., intrathecal methotrexate).
  11. Fertile men, to ensure that sexual partners can effectively prevent contraception; Women who are fertile, use effective birth control and consent to use birth control throughout the study period.

Exclusion Criteria:

  1. Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma;
  2. Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease, or any autoimmune disease involving the central nervous system;
  3. Subjects who have received other study drugs within 30 days prior to screening;
  4. Subjects who have previously received any anti-CD19 / anti-CD3 therapy or any other anti-CD19 therapy (except those with adequate bone marrow reserve and whose tumor is CD19-positive);
  5. Patients who have previously been treated with any gene therapy product, including CAR-T therapy (except those with no CAR T in the body, normal T cell count and function, and CD19-positive tumors);
  6. Subjects undergoing radiation therapy within 2 weeks prior to infusion;
  7. Subjects with active hepatitis B (defined as hepatitis B virus DNA test value > 500 IU/mL) or hepatitis C (HCV RNA positive); Hiv-positive or treponem-positive subjects;
  8. Subjects with an acute life-threatening bacterial, viral, or fungal infection that has not yet been controlled (e.g., positive blood culture ≤72 hours prior to infusion);
  9. Participants with unstable angina pectoris and/or myocardial infarction in the 6 months prior to screening;

  10. Subjects with prior or concurrent development of other malignancies, except in the following cases:

    • Adequately treated basal cell, thyroid papillary, squamous cell carcinomas (requiring adequate wound healing prior to enrollment);
    • Carcinoma in situ of cervical or breast cancer with curative treatment and no signs of recurrence for at least 3 years prior to the study;
    • The primary malignancy has been completely removed and in complete remission for ≥5 years.
  11. Clinically significant ventricular arrhythmia;
  12. Subjects received anticoagulant therapy within a week;
  13. Active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);
  14. Pregnant or lactating women, and female subjects who are planning to become pregnant within 2 years after JY231 injection infusion or male subjects whose partners plan to become pregnant within 2 years after JY231 injection infusion;
  15. Subjects who, in accordance with the investigator's judgment and/or clinical standards, are contraindicated with any study procedure or have other medical conditions that may place them at unacceptable risk.
  16. Other conditions that the investigator believes should not be included in this clinical trial, such as poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: infusion of JY231 injection
Infusion of JY231 Injection by dose of 1-10 x10^6 TU/kg、 1-5 x10^7 TU/kg、 5-10 x10^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）.
Biological: infusion of JY231 injection
Infusion of JY231 Injection by dose of 1-10 x10^6 TU/kg、 1-5 x10^7 TU/kg、 5-10 x10^7 TU/kg Administration method: intravenous infusion、intraperitoneally infusion、Lymph node infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion（PI evaluation is required）.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Month1、Month2、Month3、Month6、Month9、Month12
Metric/method of measurement:IWG-2（2007）《Revised response criteria for malignant lymphoma》
Month1、Month2、Month3、Month6、Month9、Month12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Second Provincial General Hospital

Investigators

  • Principal Investigator: Qing Zhang, Doctoral, Guangdong Second Provincial General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2023

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 11, 2023

First Submitted That Met QC Criteria

September 17, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 17, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JY-CT-23-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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