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Trial Title:
A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)
NCT ID:
NCT06644118
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
OL-101
Multiple myeloma
Phase 1
single arm
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
OL-101 infusion
Description:
OL-101 infusion will be administered to patients via IV infusion at the assigned dose.
Arm group label:
OL-101 infusion
Summary:
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).
Detailed description:
This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T
cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G
Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm,
open-label, early exploratory clinical trial, conducted in two phases: dose escalation
and dose expansion in adults with multiple myeloma. The trial begins with the
dose-escalation phase that focus on safety and tolerability, with interval assessments
for potential dose escalation or de-escalation. Recommended dose will be selected at the
completion of the dose escalation stage in the dose expansion stage. The study aims to
assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documented diagnosis of multiple myeloma according to the 2014 IMWG diagnostic
criteria
- Relapsed/refractory multiple myeloma as defined by:
1) Received at least 3 prior lines of MM treatment (must include a PI, an IMiD,
and an anti-CD38 antibody).
2）Disease progression within 12 months of the most recent anti-MM therapy; or
disease progression within the past 6 months and subsequently lack response to the
most recent line of therapy.
- Measurable disease at screening as defined by any of the following:
1. Serum monoclonal paraprotein (M-protein) level ≥1.0 g/dL or urine M-protein
level ≥200 mg/24 hours; or
2. Light chain multiple myeloma without measurable disease in the serum or the
urine: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum
immunoglobulin kappa lambda free light chain ratio.
- Positive expression of either BCMA or GPRC5D on bone marrow plasma cells; must be
GPRC5D expression positive if previously received BCMA targeted therapy
- ECOG 0-1
- Expected life expectancy exceeds 12 weeks
- Adequate bone marrow reserve or organ function meeting the following criteria:
1. Hemoglobin ≥ 70 g/L
2. Platelet count ≥ 50 × 10^9/L
3. Absolute lymphocyte count ≥ 0.3×10^9/L
4. Absolute neutrophil count ≥ 1.0 × 10^9/L
5. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 times
the upper limit of normal (ULN)
6. Total bilirubin ≤ 2 times ULN; except in subjects with congenital bilirubinemia
(such as Gilbert syndrome, in which case the direct bilirubin ≤1.5 × ULN is
required)
7. Creatinine clearance ≥ 60 mL/min (calculated by Cockcroft-Gault equation).
8. corrected serum calcium ≤12.5 mg/dL (≤3.1 mmol/L) or free ionized calcium ≤6.5
mg/dl (≤1.6 mmol/L)
9. SpO2>92% on room air
10. Left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiogram;
no clinically meaningful pericardial effusion by ultrasound
Exclusion Criteria:
- Solitary plasmacytoma
- Known active central nervous system (CNS) involvement or exhibits clinical signs of
CNS involvement of multiple myeloma.
- Received allogeneic stem cell transplant; received autologous stem cell transplant
within 12 weeks before screening
- Active second primary malignant tumor, exclude the following: cured non- melanoma
skin cancer, non-metastatic prostate cancer, cervical carcinoma in situ, ductal or
lobular carcinoma in situ of the breast
- Any other significant medical disease, abnormality, or condition that, in the
investigator judgment, may make the patient unsuitable for participation in the
study or put the patient at risk.
- Plasma cell leukemia, Waldenström's macroglobulinemia, POEMS syndrome, or primary AL
amyloidosis.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Gobroad Boren Hospital
Address:
City:
Beijing
Zip:
100071
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiequn Chen, MD, PHD
Phone:
(+86)13991832567
Email:
20203009@nwu.edu.cn
Contact backup:
Last name:
Xiequn Chen, MD, PHD
Facility:
Name:
The Affiliated Hospital of Northwest University Xi'an No.3 Hospital
Address:
City:
Xi'an
Zip:
710016
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yajin Zhang, MD, PHD
Phone:
(+86)18601333856
Email:
zhangyj3@gobroadhealthcare.com
Contact backup:
Last name:
Yajin Zhang, MD, PHD
Facility:
Name:
The first affiliated hospital, College of Medicine, Zhejiang University
Address:
City:
Hangzhou
Zip:
3100003
Country:
China
Status:
Recruiting
Contact:
Last name:
He Huang, MD, PhD
Phone:
(+86)13605714822
Email:
hehuangyu@126.com
Start date:
October 23, 2024
Completion date:
October 2028
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Overland Therapeutics
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06644118
