Multiple Myeloma Refractory
Conditions
Keywords
Relapsed/Refractory Multiple Myeloma
Brief summary
The goal of this clinical trial is to learn if the antibody drug HuL001, combined with Lenalidomide/Dexamethasone works to treat Multiple Myeloma patients. It will also learn about the safety and tolerability of the therapeutic combination. The objectives of this study are: 1. To evaluate the safety and tolerability of HuL001 (in combination with Len/Dex). 2. To evaluate the efficacy of HuL001 (in combination with Len/Dex). Researchers will use the antibody drug HuL001, combined with Len/Dex, to see if this works for Multiple Myeloma therapy. Participants will: * Receive HuL001 antibody injections every 2 weeks * Take Lenalidomide for 21 consecutive days each month * Take Dexamethasone every 1 week * Visit the clinic on scheduled days for checkups and tests * Keep a diary of their symptoms and Myeloma responses.
Interventions
DRUGHuL001
Anti-ENO1 monoclonal antibody
DRUGLenalidomide/Dexamethasone
Lenalidomide in combination with dexamethasone is indicated for the treatment of adult patients with multiple myeloma (MM)
Sponsors
HuniLife Biotechnology, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects who meet ALL inclusion criteria will be included. 1. Subjects aged 18 (inclusive) or older. 2. Confirmed diagnosis of RRMM according to the IMWG guidelines (International Myeloma Working Group updated criteria for the diagnosis of multiple myeloma, 2016). 3. Subjects must have one or more of the following measurable disease criteria: 1. Serum M-protein level ≥ 0.5 g/dL. 2. Urine M-protein level ≥ 200 mg/24 hours. 3. Light chain MM without measurable M-protein in the serum or urine: Serum immunoglobulin free light chain ≥ 10 mg/dL (local lab) and abnormal serum immunoglobulin kappa lambda free light chain ratio (per normal ranges of local lab). 4. Subjects have disease progression on, refractory to, or intolerant to at least 3 prior lines of anti-myeloma therapies or 2 prior lines of therapies with three different drugs, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory drug, and are refractory to at least one of these drugs, or who are unwilling to receive or ineligible for other standard therapies according to local medical practice. 5. There must be a time interval ≥ 3 months between the prior hematopoietic cell transplantation (HCT, counted as 1 prior line of therapy) and the first dose of HuL001. 6. All toxicities associated with the prior anti-myeloma therapy have recovered to Grade 1 or baseline at the screening. 7. Eastern Cooperative Oncology Group (ECOG) performance score of 0-1. 8. Life expectancy ≥ 6 months in the opinion of the investigator. 9. Adequate organ functions are defined as follows. 1. Hemoglobin ≥ 8.5 g/dL. 2. White blood cell (WBC) count ≥ 2.5 x 103/μL. 3. Neutrophil count ≥ 1.5 × 103/μL. 4. Platelet count ≥ 80 × 103/μL. 5. Aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN). 6. Alanine aminotransferase (ALT) ≤ 2.5 × ULN. 7. Total bilirubin ≤ 2 × ULN. 8. Creatinine clearance (CrCl) ≥ 60 mL/min, calculated using Cockcroft-Gault formula. Notes: 1. Subjects receiving hematopoietic growth factor support, e.g., erythropoietin, granulocyte-colony stimulating factor, platelet stimulator, etc. must have a 2-week interval between growth factor support and the screening evaluation. They may receive growth factor support after the DLT assessment period during the study. 2. There must be at least a 2-week interval between the last red blood cell (RBC) transfusion and hemoglobin assessment at the screening and at least a 1-week interval between the last platelet transfusion and the platelet assessment at the screening. Subjects may receive RBC and platelet transfusion after the DLT assessment period during the study. 10. Negative serology test for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV) infection. Note: If a subject with positive anti-HCV Ab, the subject must be with negative HCV RNA for enrollment. If a subject with positive HBsAg, the subject must be with undetectable HBV DNA for enrollment. 11. Female subject with reproductive potential must have a negative result of serum pregnancy test at the screening visit and urine pregnancy test before each cycle of HuL001 administration. 12. Female subject with reproductive potential and male subject with reproductive potential must agree to refrain from unprotected sex and use 2 methods of highly effective contraception with their partner (e.g., barrier contraceptives \[male condom, female condom, or diaphragm plus spermicide\], intrauterine device, hormonal methods \[hormone shot or injection, implants, combination oral contraceptives, or patches\]) for ≥ 6 months after the last dose of HuL001. 13. Physically and mentally capable of participating in the study and willing to adhere to study procedures. 14. Provision of signed informed consent.
Exclusion criteria
Subjects who meet ANY
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myeloma responses, including sCR, CR, VGPR, PR, MR, SD, PD, clinical relapse, ORR, CBR, DoR, time to sCR, time to CR, time to VGPR, time to PR, time to MR, as assessed by the investigator according to the IMWG criteria. | From enrollment to the end of treatment at 8 months | Complete Response (CR): Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, and ≤ 5% plasma cells in the bone marrow. Very Good Partial Response (VGPR): ≥ 90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 hours (or ≥ 90% reduction in serum free light chain difference if serum/urine M-proteins are unmeasurable). Partial Response (PR): ≥ 50% reduction in serum M-protein and reduction in 24-hour urine M-protein by ≥ 90% (or to \<200 mg/24 hours). If M-protein is unmeasurable, a ≥ 50% reduction in the difference between involved and uninvolved serum free light chains or bone marrow plasma cells. Minimal Response (MR): 25% to 49% reduction in serum M-protein and reduction in 24-hour urine M-protein by 50% to 89%. Stable Disease (SD): Does not meet criteria for PR, VGPR, CR, or progressive disease (not changing significantly). Progressive Disease (PD): Increase of \>25% from lowest response value in M-protein, serum fr |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety parameters, including occurrence, severity, and relationship of the TEAEs, as assessed by the NCI-CTCAE version 5.0 during the study period. | From enrollment to the end of treatment at 8 months | All AEs and toxicities are evaluated based on the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version 5.0. The 5 general grades are Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe, Grade 4: Life-threatening or disabling, and Grade 5: Death (outcome of AE). |
| Immunogenicity | From enrollment to the end of treatment at 8 months | Immunogenicity: Anti-HuL001 antibodies (ADA). |
Countries
Taiwan
Contacts
CONTACTZoe Chan, master
CONTACTMaisie Huang, PhD
STUDY_DIRECTORMaisie Huang, PhD
HuniLife Biotechnology
Outcome results
None listed