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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Study of YK012 in B-cell Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT06580301
What this study is testing
What is YK012?
YK012 is an investigational medicine, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
Also referred to as YK012 for Injection.
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
- The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of YK012 administered as monotherapy in participants with B-cell acute lymphoblastic leukemia (B-ALL).
- Phase 2: a mid-size study of how well it works
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 75
You may be able to join if
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures...
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- An estimated survival time of more than 12 weeks.
- A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions:
- Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve...
You likely can't join if
- Burkitt´s Leukemia according to World Health Organization (WHO) classification.
- History of antitumor therapy as follows, before the first dose of study drug:
- Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer
- Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks
- Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional/patent medicine that has...
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter
See the full eligibility criteria
Who can join
- Participants or their legally acceptable representative must sign an ICF indicating that the participants understand the purpose of, and procedures required for the study and are willing to participate in the study.
- Eastern Cooperative Oncology Group Performance Status (ECOG) of 0-2.
- An estimated survival time of more than 12 weeks.
- A definitive diagnosis of CD19-positive B-cell acute lymphoblastic leukemia with any of the following conditions:
- Ph-negative B-ALL with any of the following: i. Failure to achieve complete remission after initial induction therapy. ii. Failure to achieve complete remission after salvage treatment. iii. Relapse with first remission...
- Ph-positive B-ALL: failure to 1 or more tyrosine kinase inhibitors (TKIs), or intolerance to treatment with TKIs, or with the T315I mutation.
- ≥ 5% blasts in the bone marrow by morphologic assessment.
- Recovery to Grade 0-1 (Graded by National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0) from adverse events related to prior therapy except alopecia.
- Adequate hematological and organ function.
- Female participants of childbearing potential must have a negative serum pregnancy test at screening. Female patients who are sexually active must use highly effective methods of contraception throughout the study and...
- Male participants must agree to use reliable methods of contraception (barrier methods or sexual abstinence) and avoid sperm donation throughout the study period and until 3 months after the last dose.
What rules you out
- Burkitt´s Leukemia according to World Health Organization (WHO) classification.
- History of antitumor therapy as follows, before the first dose of study drug:
- Targeted therapy with small molecule drug within 2 weeks or 5 half-lives, whichever is longer
- Targeted therapy with macromolecular drug or Immunomodulatory agent therapy within 3 weeks
- Radiotherapy or chemotherapy (except for intrathecal chemotherapy and dexamethasone), or treatment with Chinese traditional/patent medicine that has definite antitumor effect within 2 weeks
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is shorter
- Receipt of any live attenuated vaccines or live virus vaccine within 4 weeks
- Autologous stem cell transplantation within 6 weeks
- History of organ transplant, or allogeneic stem cell transplantation within 12 weeks.
- Any active acute graft-versus-host disease (GvHD), grade 2-4 (according to Glucksberg criteria) or active chronic GvHD requiring systemic treatment.
- Other malignancy within 5 years, except localized malignancies that have been adequately treated or free of the disease for ≥ 5 years, e.g., basal cell carcinoma of the skin, squamous cell carcinoma of the skin...
- Active central nervous system (CNS) involvement or meningeal involvement with clinical signs, or other evidence of uncontrolled metastases to the CNS or meninges, judged by the investigator.
- a. History of or current relevant CNS pathology as epilepsy, seizure, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome, psychosis. b. Evidence for presence of inflammatory...
- History or evidence of cardiovascular disease, including:
- Acute coronary syndromes (e.g., myocardial infarction, unstable angina)
- Coronary angioplasty or stenting within 6 months prior to enrollment
- Clinically significant unstable arrhythmias (e.g., atrial fibrillation), however, atrial fibrillation has been controlled for over 30 days prior to the first dose of YK012 were allowed
- New York Heart Association (NYHA) stage III or higher congestive heart failure
- Left ventricular ejection fraction (LVEF) below lower limit of the study center, or LVEF\<50% if there is no lower limit at the study center
- The Fridericia-corrected QT interval (QTcF, mean of triplicate measurements) ≥ 470 msec (female) or ≥ 450 msec (male)
- Implantable defibrillator
- Clinically uncontrollable hypertension (i.e., SBP≥160 mm Hg and/or DBP≥100 mm Hg).
- Known allergy to monoclonal antibody drugs or exogenous immunoglobulin.
- History of CD19 targeted therapy and positive test result for immunogenicity of YK012 at screening.
- Any major organ surgery or significant trauma within 4 weeks prior to the first dose of YK012, or those requiring elective surgeries during the study, and all AEs associated with surgery or significant trauma have not...
- Regular dose of systemic corticosteroids during 4 weeks prior to initiation of study drug, or anticipated need of corticosteroids exceeding prednisone 20 mg/day or equivalent during the trial, or any other...
- Virological tests: Hepatitis B virus surface antigen (HBsAg) positive and/or hepatitis B core antibody (HBcAb) positive, and hepatitis B virus (HBV) deoxyribonucleic acid (DNA)\>ULN of the testing agency; Hepatitis C...
- Uncontrolled active infections requiring oral or intravenous systemic therapy, except for local treatment.
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage (once a month or more frequently).
- Pregnant or lactating women.
- Known mental disorder that may affect study compliance or poor compliance.
- Other serious systemic diseases or laboratory abnormalities or other reasons that the investigator believes are not appropriate for participating in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Guiyang, Guizhou, China
- Zhengzhou, Henan, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Changchun, Jilin, China
- Dalian, Liaoning, China
- Shenyang, Liaoning, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Guiyang, Guizhou, China; Zhengzhou, Henan, China; Xuzhou, Jiangsu, China; Nanchang, Jiangxi, China; Changchun, Jilin, China and 4 more location(s). 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.