Status:
UNKNOWN
JY231 Injection in the Treatment of Relapsed or Refractory B-cell Lymphoma
Lead Sponsor:
Guangdong Second Provincial General Hospital
Conditions:
Relapsed or Refractory B-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
EARLY_PHASE1
Brief Summary
Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B-cell lymphoma
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 enro...
Eligibility Criteria
Inclusion
- understand and sign the informed consent and are willing and able to comply with all test requirements;
- Age 18-75 years old, gender is not limited;
- Flow cytometry or malignant tumor cells were CD19 positive;
- 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);
- 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.
- Expected survival ≥12 weeks;
- The ECOG (Eastern Tumor Collaboration Group) score at baseline was 0 \~ 1;
- 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;
- 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;
- 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).
- 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
- Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma;
- 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;
- Subjects who have received other study drugs within 30 days prior to screening;
- 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);
- 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);
- Subjects undergoing radiation therapy within 2 weeks prior to infusion;
- 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;
- 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);
- Participants with unstable angina pectoris and/or myocardial infarction in the 6 months prior to screening;
- 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.
- Clinically significant ventricular arrhythmia;
- Subjects received anticoagulant therapy within a week;
- Active neuroautoimmune or inflammatory conditions (e.g. Guillian-Barre syndrome, amyotrophic lateral sclerosis);
- 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;
- 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.
- Other conditions that the investigator believes should not be included in this clinical trial, such as poor compliance.
Key Trial Info
Start Date :
August 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06045585
Start Date
August 18 2023
End Date
December 31 2025
Last Update
September 21 2023
Active Locations (1)
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1
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, China, 510317