Actively Recruiting
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Led by Zhejiang University · Updated on 2024-11-08
58
Participants Needed
3
Research Sites
205 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
O
Overland Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).
CONDITIONS
Official Title
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic criteria
- Relapsed or refractory multiple myeloma with at least 3 prior treatments including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody
- Disease progression within 12 months of the most recent anti-myeloma therapy or progression within 6 months followed by lack of response to the most recent therapy
- Measurable disease defined by serum or urine M-protein levels or abnormal serum free light chain levels
- Positive expression of BCMA or GPRC5D on bone marrow plasma cells; must be GPRC5D positive if previously treated with BCMA therapy
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Expected life expectancy longer than 12 weeks
- Adequate bone marrow and organ function including hemoglobin ≥ 70 g/L, platelet count ≥ 50 × 10^9/L, lymphocyte count ≥ 0.3 × 10^9/L, neutrophil count ≥ 1.0 × 10^9/L
- Liver enzymes (ALT and AST) ≤ 2.5 times upper limit of normal
- Total bilirubin ≤ 2 times upper limit of normal (except for certain congenital conditions)
- Creatinine clearance ≥ 60 mL/min
- Corrected serum calcium ≤ 12.5 mg/dL or free ionized calcium ≤ 6.5 mg/dL
- Oxygen saturation (SpO2) > 92% on room air
- Left ventricular ejection fraction (LVEF) ≥ 50% without significant pericardial effusion
You will not qualify if you...
- Solitary plasmacytoma
- Known active central nervous system involvement or clinical signs of CNS involvement of multiple myeloma
- Received allogeneic stem cell transplant or autologous stem cell transplant within 12 weeks before screening
- Active second primary malignant tumor except cured non-melanoma skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, or certain breast carcinomas in situ
- Any other significant medical condition or abnormality considered unsafe or unsuitable by the investigator
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL amyloidosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Beijing Gobroad Boren Hospital
Beijing, Beijing Municipality, China, 100071
Not Yet Recruiting
2
The Affiliated Hospital of Northwest University Xi'an No.3 Hospital
Xi’an, Shanxi, China, 710016
Not Yet Recruiting
3
The first affiliated hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 3100003
Actively Recruiting
Research Team
H
He Huang, MD, PhD
CONTACT
Y
Yongxian Hu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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