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New treatment option for B-ALL
Official title KSV01 Injection as the Therapy for Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT07246707
What this study is testing
What is KSV01 Injection?
KSV01 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for b-all.
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 is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 injection for patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Voluntary participation and provision of written informed consent by the patient or their legally authorized representative.
- Aged 18 to 80 years (inclusive), any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Life expectancy \> 3 months.
- Diagnosis of B-cell Acute Lymphoblastic Leukemia (B-ALL) according to the 2016 WHO classification, with relapsed/refractory disease defined by...
You likely can't join if
- Diagnosis of Burkitt's leukemia/lymphoma according to WHO 2016, or chronic myeloid leukemia in accelerated or blast phase.
- History of another primary malignancy that has not been in continuous remission for at least 2 years. Exceptions to the 2-year limit include...
- Uncontrolled active infection within 4 weeks prior to enrollment.
- Active hepatitis B or hepatitis C virus infection.
- HIV infection.
- Positive for Treponema pallidum(syphilis).
See the full eligibility criteria
Who can join
- Voluntary participation and provision of written informed consent by the patient or their legally authorized representative.
- Aged 18 to 80 years (inclusive), any gender.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
- Life expectancy \> 3 months.
- Diagnosis of B-cell Acute Lymphoblastic Leukemia (B-ALL) according to the 2016 WHO classification, with relapsed/refractory disease defined by meeting at least one of the following criteria:
- Relapse within 12 months of achieving first remission with standard therapy.
- Primary refractory disease: failure to achieve Complete Remission (CR) after two or more cycles of standard chemotherapy.
- Relapsed disease after two or more instances of CR.
- Relapsed or refractory disease following autologous or allogeneic Hematopoietic Stem Cell Transplantation (HSCT).
- Documented CD19-positive leukemia cells in bone marrow or peripheral blood within 1 month prior to screening.
- Morphological disease in the bone marrow (blasts ≥5%).
- For patients with Philadelphia chromosome-positive ALL (Ph+ ALL): must be refractory or intolerant to at least two Tyrosine Kinase Inhibitors (TKIs), including at least one second-generation TKI. Patients with a T315I...
- Absolute Lymphocyte Count (ALC) ≥ 100/μL.
- Adequate organ function as defined by:
- Hepatic: Alanine aminotransferase (ALT) ≤ 3 × Upper Limit of Normal (ULN); Aspartate aminotransferase (AST) ≤ 3 × ULN; Total bilirubin ≤ 2 × ULN (or ≤ 3 × ULN with a diagnosis of Gilbert's syndrome, with direct...
- Renal: Creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 60 mL/min.
- Pulmonary: Oxygen saturation (SaO2) ≥ 92% on room air, and no active pulmonary infection.
- Cardiac: Left Ventricular Ejection Fraction (LVEF) ≥ 40% by echocardiography; absence of significant pericardial effusion; no clinically significant electrocardiogram (ECG) abnormalities.
- For women of childbearing potential: negative urine or serum pregnancy test at screening, and agreement to use effective contraception for at least 1 year post-infusion. Male people with partners of childbearing...
- For people with prior blinatumomab (CD3-CD19 bispecific T-cell engager) therapy: CD19 tumor expression on blasts (from bone marrow or peripheral blood) must be documented after the most recent cycle of blinatumomab. If...
What rules you out
- Diagnosis of Burkitt's leukemia/lymphoma according to WHO 2016, or chronic myeloid leukemia in accelerated or blast phase.
- History of another primary malignancy that has not been in continuous remission for at least 2 years. Exceptions to the 2-year limit include: non-melanoma skin cancer, curatively treated Stage I solid tumor with low...
- Uncontrolled active infection within 4 weeks prior to enrollment.
- Active hepatitis B or hepatitis C virus infection.
- HIV infection.
- Positive for Treponema pallidum(syphilis).
- Severe active autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.
- History of severe allergy or hypersensitivity to macromolecular biological agents (e.g., antibodies, cytokines).
- Participation in another treatment clinical trial within 4 weeks prior to enrollment.
- History of clinically significant central nervous system (CNS) disorders, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic...
- Central Nervous System (CNS) involvement:
- Presence of CNS 3 disease, defined as detectable blasts in the cerebrospinal fluid (CSF) with ≥5 WBCs/mm³, with or without neurological symptoms.
- Presence of CNS 2 disease, defined as detectable blasts in the CSF with \<5 WBCs/mm³ AND the presence of neurological symptoms. Note: people with CNS 1 status (no detectable leukemic blasts in CSF) and people with CNS 2...
- History or presence of any CNS disorder, such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, any autoimmune disorder involving the CNS, posterior reversible encephalopathy...
- History of concomitant genetic syndromes associated with bone marrow failure, such as Fanconi anemia, Kostmann syndrome (severe congenital neutropenia), Shwachman-Diamond syndrome.
- History of any of the following cardiovascular conditions within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable...
- Active psychiatric illness.
- History of drug abuse/addiction.
- Use of the following medications or therapies:
- Salvage systemic therapy (including chemotherapy, TKIs for Ph+ ALL, and blinatumomab) within 1 week or 5 half-lives (whichever is shorter) prior to study drug infusion. Note: TKIs and hydroxyurea must be discontinued at...
- Prior anti-CD19 therapy other than blinatumomab.
- History of Grade 4 neurological toxicity (per CTCAE v6.0) or Grade 4 CRS (per Lee 2014 criteria) during prior blinatumomab treatment.
- Prior treatment with alemtuzumab within 6 months, or with clofarabine or cladribine within 3 months prior to study drug infusion.
- Systemic treatment for Graft-versus-Host Disease (e.g., calcineurin inhibitors, methotrexate, mycophenolate mofetil, sirolimus, thalidomide) or immunosuppressive antibody therapy (e.g., anti-CD20, anti-TNF, anti-IL-6...
- Any prior systemic therapy with inhibitory/stimulatory immune checkpoint molecules (e.g., ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists). A washout period of at least 3 half-lives...
- Radiotherapy: Non-CNS directed radiotherapy within 2 weeks or CNS-directed radiotherapy within 8 weeks prior to study drug infusion.
- Corticosteroids: Therapeutic doses of corticosteroids (defined as prednisone equivalent \>20 mg/day) within 72 hours prior to study drug infusion. Physiologic replacement doses, and topical or inhaled steroids are...
- Prior gene therapy.
- Acute Graft-versus-Host Disease (GVHD) of Grade II to IV per Glucksberg criteria, or overall grade B-D per the IBMTR Severity Index; OR acute or chronic GVHD requiring systemic therapy within 4 weeks prior to enrollment.
- Administration of a live vaccine within 4 weeks prior to enrollment.
- Pregnancy or lactation.
- Any condition that, in the investigator's judgment, may compromise the subject's ability to complete all required study visits and procedures (including follow-up), or comply with the study requirements.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, 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.