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New treatment option for B Acute Lymphoblastic Leukemia
Official title JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia
ClinicalTrials.gov ID: NCT06940960
What this study is testing
What is JY231 Injection?
JY231 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 24 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 75
You may be able to join if
- Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
- Age is 12-75 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...
- Refractory B-ALL: those who did not achieve complete remission after 2 courses of standard induction regimen chemotherapy, or those who did not...
You likely can't join if
- people with active cerebrospinal fluid malignant cells or brain metastases, or people with active central nervous system (CNS) lymphoma, or CNS...
- people with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune...
- people 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...
- Patients who have been previously treated with any gene therapy product, including Chimeric Antigen Receptor T(CAR-T) therapy (except patients who do...
- people with radiation therapy within 2 weeks prior to the infusion;
See the full eligibility criteria
Who can join
- Subject voluntarily sign informed consent and are willing and able to comply with all trial requirements;
- Age is 12-75 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...
- 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...
- 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...
- 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...
- 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;
- Total bilirubin ≤1.5 times ULN;
- Serum creatinine ≤ 1.5 times ULN, or creatinine clearance ≥ 60 mL/min;
- Indoor oxygen saturation ≥ 92%;
- Left ventricular ejection fraction (LVEF)≥55%, echocardiography confirmed no pericardial effusion and no clinically significant ECG findings;
- There is no clinically significant pleural effusion;
- Adequate bone marrow reserve without transfusion, defined as:
- Absolute neutrophil count (ANC)\>1.000 / mm3;
- Absolute lymphocyte count (ALC)≥ 300 / mm3;
- Platelet≥50.000/mm3;
- Hemoglobin\>8.0 g/dl;
- people using the following drugs need to meet the following conditions:
- Steroids: The therapeutic dose of steroids must be stopped 72 hours before JY231 infusion. However, physiological alternative doses of steroids are allowed;
- Immunosuppression: Any immunosuppressive drug must be stopped at ≥4 weeks prior to enrollment;
- Antiproliferative therapy other than lymphodepletion chemotherapy within two weeks of infusion;
- Cluster of Differentiation 20(CD20) antibody-related therapy must be stopped within 4 weeks before infusion or 5 half-lives after the CD20 antibody;
- CNS disease prophylaxis must be stopped 1 week before JY231 infusion (e. g. intrathecal methotrexate).
- Reproductive men, sexual partners ensure effective contraception; fertile women, adopted effective contraception and agreed to use contraception throughout the study period.
What rules you out
- people with active cerebrospinal fluid malignant cells or brain metastases, or people with active central nervous system (CNS) lymphoma, or CNS leukaemia;
- people with a history of active CNS disease, such as seizures, cerebrovascular ischemia / hemorrhage, dementia, cerebellar disease, or any autoimmune disease associated with CNS involvement;
- people 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...
- 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...
- people with radiation therapy within 2 weeks prior to the infusion;
- people with active hepatitis B (defined as Hepatitis B Virus(HBV) DNA test value\> 500 IU / mL) or hepatitis C (HCV RNA positive); people with HIV positive or treponema pallidum positive;
- people with uncontrolled acute life-threatening bacterial, viral, or fungal infection (e. g. positive blood culture 72 hours before infusion);
- people with unstable angina pectoris and / or myocardial infarction within the 6 months prior to screening;
- people 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 people without medical management control;
- people receiving oral anticoagulation within 1 week before JY231 injection infusion;
- Having active neurological autoimmune or inflammatory conditions (such as Guillain-Barre syndrome, amyotrophic lateral sclerosis);
- Female people in pregnant or lactating, or women with planned pregnancy within 2 years after JY231 infusion or male partner with planned pregnancy within 2 years after JY231 infusion;
- people with taboo study procedures or other medical conditions that may put them at unacceptable risk according to the investigator's judgment and / or clinical criteria.
- Other conditions that the investigator believes that the people should not be enrolled in this clinical trial, such as poor compliance.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.