Study of YK012 in B-cell Acute Lymphoblastic Leukemia

NCT06580301 | Recruiting Phase 1

• 1 other identifier: YK012-2
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 12

Brief Summary

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).

Conditions

B-cell Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (5)

• The Incidence and Profile of Dose-limiting Toxicity (DLT)

  The toxicities occurring within 28 days (i.e., DLT observation period) after the first dose will be defined as DLTs in the discretion of the investigator as related to the IMP (Investigational Medicinal Product). This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.

  28 days after the first dose

• Maximum Tolerated dose (MTD) or The Recommended Dose for Future Clinical Study

  This outcome measure is applicable for dose escalation phase only. The MTD dose will be calculated by the statistician upon completion of the dose escalation study.

  Through study completion, 20 weeks

• Number of Participants with Adverse Events

  An AE is defined as any untoward medical event that occurs after a subject receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the investigational drug.

  From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.

• Number of Participants with Serious Adverse Events

  An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the subject receives the IMP, and congenital abnormalities or birth defects.

  From the time the participant signs the ICF until the end of the safety visit period, assessed up to 24weeks.

• Dose Expansion Phase: Objective Response Rate (ORR)

  ORR is defined as percentage of participants achieving either a complete response (CR) or complete remission with partial hematological recovery (CRi). The MTD dose will be calculated by the statistician upon completion of the dose escalation study. This outcome measure is applicable for dose expansion phase only.

  From the time the participant signs the ICF until hematological relapse, assessed up to 1 year

Secondary Outcomes (11)

• Area Under the Concentration-time Curve (AUC)

  Up to 20 weeks

• Maximum Observed Concentration (Cmax)

  Up to 20 weeks

• Time to Reach Maximum Concentration (Tmax)

  Up to 20 weeks

• Half Life (t1/2) of YK012

  Up to 20 weeks

• Clearance (CL) of YK012

  Up to 20 weeks

Study Arms (1)

YK012

EXPERIMENTAL

Participants will be assigned to a dose level of YK012 based on when the participants join this study. Participants will receive YK012 by intravenous infusion (IV), once per week, four weeks per treatment cycle.

Drug: YK012

Interventions

YK012 DRUG

The treatments include 2 cycles of induction treatment, 3 cycles of consolidation treatment, and up to 5 cycles of maintenance treatment.

Also known as: YK012 for Injection

YK012

Eligibility Criteria

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

You may qualify if:

• 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 duration ≤12 months. iv. Second or later relapse. v. Relapse after hematopoietic stem cell transplantation (HSCT).
• 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 for 3 months following the last dose of study treatment.
• 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.

You may not qualify 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 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, non-muscle invasive bladder cancer, localized prostate cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast.
• 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 lesions and/or vasculitis on cerebral MRI.
• History or evidence of cardiovascular disease, including:
• Acute coronary syndromes (e.g., myocardial infarction, unstable angina)

Sponsors & Collaborators

• Excyte Biopharma Ltd: lead

Study Sites (12)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Affiliated Zhongshan Hospital of Dalian University

Dalian, Liaoning, 116001, China

RECRUITING

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110000, China

RECRUITING

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, 650033, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Burkitt Lymphoma

Interventions

Injections

Condition Hierarchy (Ancestors)

Epstein-Barr Virus Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Tumor Virus Infections; Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jie Jin, MD

  Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Jin, MD

CONTACT

+86-0571-87236898; jiej0503@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 30, 2024
• Study Start: September 25, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

CN (12)