Actively Recruiting
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients
Led by Curocell Inc. · Updated on 2021-05-03
91
Participants Needed
1
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multi-center, phase I/II study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma.
CONDITIONS
Official Title
Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years of age or older and provided written informed consent
- Histologically confirmed large B-cell lymphoma subtype including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or transformed follicular lymphoma
- Relapsed or refractory disease after two or more lines of chemotherapy including rituximab and anthracycline, with failed or ineligible for autologous stem cell transplantation
- At least one measurable lesion with a longest diameter of 1.5 cm or more
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate renal and liver function based on specific laboratory values
- Adequate blood counts without transfusions within 2 weeks prior to screening
- Minimum pulmonary reserve with grade 1 or less dyspnea and oxygen saturation above 91% on room air
- Hemodynamically stable with no significant heart issues and left ventricular ejection fraction 50% or higher
- Availability of apheresis product of non-mobilized cells accepted for manufacturing
- Life expectancy of at least 12 weeks
- Agreement to use effective contraception for 12 months post CRC01 infusion if applicable
You will not qualify if you...
- Previous or concurrent malignancy except certain treated cancers without recurrence for specified years
- Unstable angina or heart attack within 12 months prior to screening
- Recent thromboembolic events, pulmonary embolism, or bleeding disorders within 6 months prior to screening
- Hypoxemia, significant pleural effusion, or abnormal EKG within 6 months prior to screening
- Central nervous system involvement by lymphoma
- Active infections including hepatitis B, hepatitis C, or HIV
- Active neurologic autoimmune or inflammatory disorders
- Uncontrolled heart rhythm disorders within 3 months prior to screening
- Rapidly progressing disease as judged by the investigator
- Major surgery within 4 weeks prior to screening except certain thoracic surgeries within 2 weeks
- Severe or uncontrolled infections
- Prior treatment with anti-CD19 or anti-CD3 therapies, adoptive T cell therapy, gene therapy, or allogeneic stem cell transplant
- Use of oral anticoagulants
- Eligible for and consenting to autologous stem cell transplant
- Use of investigational drugs within 4 weeks prior to screening
- Pregnant or lactating women
- Allergic reactions to components of CRC01
- Recent anti-cancer or immunosuppressive treatments within specified time frames
- Steroid use above physiological replacement doses within specified time frames
- CNS disease prophylaxis within 1 week prior to CRC01 infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea, 06351
Actively Recruiting
Research Team
B
Bom-I Kwon, BSc
CONTACT
G
Gunsoo Kim, MSc
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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