JY231(JY231) Injection for the Treatment of Relapsed or Refractory B Cell Lymphoma/ Leukemia

NCT06678282 | Recruiting

• 1 other identifier: JY-CT-23-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with relapsed or refractory B cell lymphoma / leukemia. It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of relapsed or refractory B cell lymphoma / leukemia.

Conditions

B-NHL; B-ALL

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events(AE) after infusion

  The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

  Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

• Maximum Tolerated Dose(MTD)

  MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

  Up to 28 days after infusion

Secondary Outcomes (1)

• Objective Response Rate

  Up to 3 months after infusion

Study Arms (1)

JY231 Injection for the Treatment of relapsed or refractory B cell lymphoma/ leukemia

EXPERIMENTAL

Subjects who meet the Inclusion Criteria will receive intravenous JY231. JY231 infusion will produce in vivo CAR-T cells in the body.

Drug: JY231 Injection

Interventions

JY231 Injection DRUG

The starting dose of this study was set at 1\~10×10\^6 transduction units (TU) / kg and escalated at 2\~5×107\^TU/kg and 6\~10×10\^7 TU/kg.

JY231 Injection for the Treatment of relapsed or refractory B cell lymphoma/ leukemia

Eligibility Criteria

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

You may qualify if:

• Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
• Age is 18-75 years old and gender is not limited;
• Malignancy cells in bone marrow or peripheral blood are Cluster of Differentiation 19 - positive(CD19+) detected by flow cytometric analysis;
• Meet the clinical criteria for relapsed or refractory B-cell lymphoma, including: indolent lymphoma (iNHL), such as follicular lymphoma (FL) and marginal zone lymphoma (MZL); aggressive B-cell lymphoma, like diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed follicular lymphoma (TFL), and T-rich lymphocyte-bearing large B-cell lymphoma (TCRBCL), or have a diagnosis of acute B-lymphocytic leukemia (B-ALL) and meet one of the following conditions:
• Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not achieve complete remission after first-line or multi-line salvage chemotherapy;
• Relapsed B-ALL: relapse within 12 months after first remission, or relapse after first-line / multi-line salvage chemotherapy;
• Relapse after autologous or allogeneic hematopoietic stem cell transplantation; In addition, patients with Philadelphia chromosome positive (Ph +) should be relapsed after at least two tyrosine kinase inhibitors (TKI) treatment, or they could not tolerate TKI therapy, or have a t315i mutation, resistant to TKI drugs.
• Morphological examination of bone marrow cells showed the proportion of primitive and naive lymphocytes was\> 5%;
• No Hematopoietic Stem Cell Transplantation(HSCT) within 6 months before enrollment;
• At least one measurable lesion was imaging for relapsed or refractory B cell lymphoma, long diameter of\> 15mm, or extranodal lesion of\> 10mm, along with a positive Positron Emission Tomography - Computed Tomography(PET-CT) examination.
• More than 12 weeks of expected survival period
• Baseline Eastern Cooperative Oncology Group(ECOG) score was 0-1;
• Adequate organ function (criteria regarding liver and kidney function can be moderately relaxed):
• Glutamic aminotransferase (ALT) ≤3 times upper limit of normal (ULN);
• Grass aminotransferase (AST) ≤3 times ULN;

You may not qualify if:

• Subjects with active cerebrospinal fluid malignant cells or brain metastases, or subjects with active central nervous system (CNS) lymphoma, or CNS leukaemia;
• Subjects with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;
• Subjects who have received other study drugs within 30 days before screening, or are still in the washout period;
• Patients who have previously received any anti-CD19 / anti-Cluster of Differentiation 3(CD3) therapy or any other anti-CD19 therapy (except for those with normal T cell numbers and function and with CD19-positive tumors);
• Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do not have CAR-T cells in vivo and have normal T cell number and function and are with CD19 positive tumors);
• Subjects with radiation therapy within 2 weeks prior to the infusion;
• Subjects with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\> 500 IU / mL) or hepatitis C (HCV RNA positive); subjects with HIV positive or treponema pallidum positive;
• Subjects with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);
• Subjects with unstable angina pectoris and / or myocardial infarction within the 6 months prior to screening;
• Subjects with concurrent or previously diagnosed with other malignancies, except for the patients under following conditions:
• Well treated basal cells, papillary thyroid carcinoma, squamous cell carcinoma (adequate wound healing is required before enrollment into this study);
• Carcinoma in situ of cervical cancer or breast cancer, after curative treatment, showed no signs of recurrence for at least 3 years before the study;
• The primary malignancy has been completely removed and is in complete remission for 5 years.
• Arrhythmic subjects without medical management control;
• Subjects receiving oral anticoagulation within 1 week before JY231 injection infusion;

Sponsors & Collaborators

• Shenzhen Genocury Biotech Co., Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhenzhou, Henan, 450000, China

RECRUITING

Study Officials

• Yi Zhang, Doctor

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinfeng Chen, Doctor

CONTACT

15837167101; Fengxinchen1985@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician and Professor

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: September 7, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 7, 2024

Record last verified: 2024-11

Locations

CN (1)