To assess the safety, immunogenicity and preliminary efficacy of 3D189 in patients with hematological malignancies.
This is a phase 1, open-label, non-comparative, multicenter study of 3D189 (also known as galinpepimut-S), a multivalent peptide vaccine targeting Wilms Tumor-1 (WT1), for maintenance immunotherapy in patients with WT1-positive hematological malignancies, including patients with acute leukemia (AL) patients in complete remission (CR), or multiple myeloma (MM), non-Hodgkin lymphoma (NHL) or higher-risk myelodysplastic syndrome (MDS) patients who have received at least first-line standard therapy and recently achieved CR or partial remission (PR), if the latter is the best achievable response for the patient.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
3D189 (200 mcg per peptide x 4 WT1 peptides within the drug product; total weight: 800 mcg) is mixed (1:1 v/v) and emulsified with the adjuvant Montanide, which is then injected subcutaneously to the patient. A maximum of 15 total injections of 3D189 will be administered as follows: 1. Initial immunization induction phase(the first series of 6 injections of 3D189): every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. 2. Early immune booster phase(the second series of 6 injections of 3D189): every 4 weeks (between Weeks 14 and 34) followed by a 6-week period of no treatment. 3. Late immune booster phase(the third series of 3 injections of 3D189): every 6 weeks (between Weeks 40 and 52).
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical
Shengyang, Liaoning, China
Blood Disease Hospital , Chinese Academy of Medical Science
Tianjing, Tianjing, China
Number and frequency of TRAEs, including AE and SAEs (safety parameters)
ncidence and severity of adverse events (AEs) and serious adverse events (SAEs) related to the study treatment (graded in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0)
Time frame: From the initiation of study treatment to the completion of safety follow-up after the end of study treatment, up to 13 months
Immune response rate of 3D189 vaccination among subjects
The rate of positive results for any of the immune tests used to assess the WT1 -specific T-cell immune responses.
Time frame: From baseline (pre-treatment) to the end of study treatment,up to 12 months
Overall survival (OS)
From time of registration to the time of subject death.
Time frame: up to 24 months
Relapse-free survival (RFS) or progression-free survival (PFS)
From time of registration to the time of documented morphological leukemic relapse (for AL patients only) or disease progression (for MDS, MM and NHL patients) or subject death (for all patients)
Time frame: up to 12 months
Overall response rate (ORR)
Partial response (PR) or complete response (CR) in MDS, MM or NHL patients receiving 3D189 treatment, as evaluated by the investigators according to the corresponding response evaluation criteria and by comparison with baseline.
Time frame: up to 12 months
Duration of Response (DoR)
Time interval between the documentation of ORR (CR/PR) post study treatment and the documentation of progressive disease (PD) (for MDS, MM or NHL patients).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 12 months
Disease control rate (DCR)
The percentage of patients who achieve CR or PR post study treatment or who remain stable for at least the first 12 weeks of study treatment (for MDS, MM or NHL patients).
Time frame: up to 12 months