Inclusion Criteria:
- - Subjects must be willing and able to understand and provide signed informed consent
for the study.
- - Male or female patients ≥ 18 years of age on the day of signing informed consent.
- - Have a histologically or cytologically confirmed hematological malignancy and have
achieved complete remission (CR) or partial remission (PR) after at least one line of
standard therapy, and are not suitable for hematopoietic stem cell transplant (HSCT)
for the following reasons: a) not eligible for HSCT due to intercurrent medical
conditions; b) lack of an available HLA-matched donor for allogeneic HSCT; c) not able
to accept HSCT for financial reasons; d) without a potential indication for HSCT (e.g.
having a relatively favorable prognosis or low risk of relapse).
However, patients who
have previously received autologous HSCT but remain MRD+ or in remission after salvage
therapy for post-transplant relapse are allowed to be recruited.
Including the following 4 types of hematological malignancies:
1. Acute Leukemia (AL): including acute myeloma leukemia (AML) and acute lymphoblastic
leukemia (ALL), in morphological complete remission with complete or incomplete blood
count recovery (CR or CRi), and having completed any planned post-remission therapy;
2. Myelodysplastic Syndrome (MDS): Revised International Prognostic Scoring System
(IPSS-R) risk score > 3.5, having achieved CR or PR following prior therapy;
3. Multiple Myeloma (MM): having achieved stringent complete response (sCR), CR or very
good partial response (VGPR), or PR if deeper response cannot be obtained from
adequate therapy.
4. Non-Hodgkin Lymphoma (NHL): preference for patients with diffuse large B-cell lymphoma
(DLBCL) and follicular lymphoma (FL) who have achieved CR or PR following prior
therapy.
- - Have a documented WT1 positive disease.
This is defined as detectable presence of
WT1 transcript via real-time quantitative polymerase chain reaction (RT-PCR) in
patients'bone marrow or peripheral blood samples, or WT1 expression by
immunohistochemistry (IHC) in archived (paraffin embedded, unstained slides) or
freshly biopsied tumor tissues from bone marrow or lymph nodes or extranodal
lesions ( for NHL patients).
- - Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
- - Estimated life expectancy ≥ 6 months.
- - The interval between the last antitumor therapy (including surgery, radiotherapy
and systemic therapy) and the first study treatment must be at least 4 weeks or
10 half-lives of chemotherapy drugs (whichever is shorter), and the toxicity of
the previous therapies have recovered to ≤ grade 1 [according to the Common
Terminology Criteria for Adverse Events (CTCAE) 5.0], except for toxicity such as
alopecia, which in the judgment of the investigator is not a safety risk.
- - Have adequate organ and bone marrow function, defined as follows:
1) Blood count (participants must not have received transfusion of blood products within 7
days prior to this test): hemoglobin (Hb) ≥ 9.0 g/dL; neutrophil (NEUT) ≥ 1.0×109/L;
platelet (PLT) ≥ 50×109/L; 2) Liver function: alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤ 2.5 ×ULN (upper limit of normal); but for subjects with liver
metastasis, ALT or AST ≤ 5×ULN; total bilirubin (TBIL) ≤ 1.5 × ULN, or TBIL > 1.5 × ULN,
but direct bilirubin (DBIL) ≤ 1.0 × ULN; 3) Renal function: serum creatinine ≤ 1.5 × ULN or
endogenous creatinine clearance rate ≥ 50 ml/min (Cockcroft-Gault formula); 4) Coagulation:
international normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤
1.5 ×ULN, unless subjects are receiving anticoagulant therapy as long as INR or APTT is
within the therapeutic range of intended use of anticoagulants; 5) Cardiac function: left
ventricular ejection fraction (LVEF) ≥ 50% by echocardiography.
• Subjects (including partners) must agree to use an adequate method of contraception,
starting with the screening visit through 4 months after the last dose of study treatment.
Exclusion Criteria:
- - Previously treated with any therapy targeting WT1.
- - Have known hypersensitivity to peptide biologics, or to immune adjuvants Montanide
and/or GM-CSF.
- - Subjects with acute promyelocytic leukemia (APL or M3).
- - Presence of central nervous system (CNS) invasion and/or carcinomatous meningitis;
participants with previously cured brain or meningeal metastasis can be allowed.
- - Have undergone prior allogeneic HSCT, or plan to perform HSCT during the study period.
- - Received live vaccine within 4 weeks prior to the first dose of study treatment.
- - Currently participate in or have participated in a study of an interventional agent or
device within 4 weeks prior to the first dose of study treatment.
- - Have a known additional malignancies within the past 5 years, with the exception of
cured skin basal cell carcinoma or cervical cancer in situ or other carcinoma in situ.
- - Have an active autoimmune disease or any disease that requires long-term use of
systemic corticosteroids (at doses greater than 10 mg daily of prednisone equivalent)
or any other form of immunosuppressive agents, hormone replacement therapy for
adrenocortical insufficiency, hypopituitarism, hypothyroidism, or type I diabetes
mellitus is not considered a form of systemic treatment and is allowed.
- - Have a diagnosis of primary immunodeficiency disease, or acquired immunodeficiency
syndrome, or a positive test for human immunodeficiency virus (HIV).
- - Presence of active tuberculosis.
- - Have a history of a severe cardiovascular disease such as class III or IV heart
failure [New York Heart Association (NYHA) criteria], myocardial infarction or stroke,
unstable angina within 6 months prior to start of study treatment.
- - QTcF interval tested during the screening period ≥ 450 msec (for male subjects) or ≥
470 msec (for female).
- - Have an acute severe infection requiring systemic therapy during the screening period.
- - Positive for HBsAg and HBV DNA ≥ 103 IU/ml; or positive for HCV antibodies and HCV RNA
level is above the detection limit.
- - Are pregnant or breastfeeding, or have a positive serum pregnancy test during the
screening period (for female subjects of childbearing potential).
- - Have a known psychiatric or substance abuse disorder that would interfere with the
participant's ability to cooperate with the requirements of the study.
- - Any condition, therapy or laboratory abnormality that, in the opinion of the
investigator, might affect the participant's compliance, pose an unwarranted high risk
to the participant, or interfere with the interpretation of the study results.
