Actively Recruiting
Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies
Led by Westlake Therapeutics · Updated on 2024-07-24
30
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors.
CONDITIONS
Official Title
Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced malignancies
- Male or female aged 18 to 75 years at time of consent
- Dose escalation stage: advanced solid tumors with at least 2 prior regimens including checkpoint inhibitor therapy in last regimen, or unable to tolerate standard therapy but last regimen includes checkpoint inhibitor therapy; relapsed and refractory malignant lymphomas without standard therapy or unable to receive it, using checkpoint inhibitor therapy in last regimen; no systemic therapy after disease progression within 3 months, radiotherapy allowed
- Dose expansion stage: advanced solid tumors with at least 1 prior regimen or no standard therapy or unable to receive standard therapy, with checkpoint inhibitor therapy in last regimen; relapsed and refractory malignant lymphomas without standard therapy or unable to receive it, using checkpoint inhibitor therapy in last regimen; no systemic therapy after progression within 3 months, radiotherapy allowed
- Solid tumors with at least one measurable lesion by RECIST 1.1; lymphomas with at least one visible or measurable lesion by Lugano 2014
- ECOG performance status 0 or 1
- Washout period before treatment: 28 days after last tumor treatment or 5 half-lives, whichever is shorter
- Resolution of acute reversible toxic effects of prior therapy or surgery to baseline or Grade 3 except alopecia and peripheral neurotoxicity
- Adequate organ function
- Estimated life expectancy of at least 12 weeks
- Able to give signed informed consent and comply with study requirements
You will not qualify if you...
- Active or suspected autoimmune diseases
- Serious medical conditions such as uncontrolled diabetes, active peptic ulcer, liver cirrhosis, active bleeding, uncontrolled or serious cardiovascular diseases including NYHA II or higher heart failure, unstable angina, recent myocardial infarction within 6 months, uncontrolled hypertension (systolic 180 mmHg or diastolic 100 mmHg)
- Known active Hepatitis B, Hepatitis C, or HIV infection
- Active brain metastases or cancerous meningitis
- History of diseases affecting red blood cell production quality and stability
- Prior removal of spleen or planned splenectomy during trial
- Received live virus vaccination within 6 months before first dose, except COVID-19 inactivated vaccine
- History of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severely impaired lung function
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Provincial People'S Hospital
Hangzhou, Zhejiang, China, 310014
Actively Recruiting
Research Team
X
xiangmin Tong, Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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