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

NCT06045585 | Unknown Early Phase 1

• 1 other identifier: JY-CT-23-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Relapsed or Refractory B-cell Lymphoma

Keywords

JY231injection; Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Metric/method of measurement:IWG-2（2007）《Revised response criteria for malignant lymphoma》

  Month1、Month2、Month3、Month6、Month9、Month12

Study Arms (1)

infusion of JY231 injection

EXPERIMENTAL

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

Interventions

infusion of JY231 injection BIOLOGICAL

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）.

infusion of JY231 injection

Eligibility Criteria

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Guangdong Second Provincial General Hospital: lead

Study Sites (1)

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, 510317, China

RECRUITING

Related Publications (9)

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MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell; Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Qing Zhang, Doctoral

  Guangdong Second Provincial General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qing Zhang, Doctoral

CONTACT

+86 20 8916 8162; zhqing@vip.163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 21, 2023
• Study Start: August 18, 2023
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

CN (1)