Actively Recruiting
Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma
Led by Beijing Yongtai Ruike Biotechnology Company Ltd · Updated on 2024-08-27
25
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a phase I clinical trial aimed at the safety and tolerability of RC19D2 cell injection in the treatment of CD19 positive patients with recurrent or refractory diffuse large B-cell lymphoma
CONDITIONS
Official Title
Phase I Clinical Trial of RC19D2 Cell Injection in the Treatment of Diffuse Large B-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign the informed consent form
- Age 18 years or older at screening, any gender
- Diagnosed with CD19-positive diffuse large B-cell lymphoma confirmed by histopathology or cytology
- Have failed standard treatments and currently lack effective options for recurrent or refractory disease
- Have completed at least two lines of treatment including CD20 targeted drugs and anthracycline drugs if CD20 positive, with recurrence, no remission, or progression; or have recurrence, no remission, or progression after autologous hematopoietic stem cell transplantation
- Diagnosed with one of the following lymphoma types: diffuse large B-cell lymphoma non-specific, transforming follicular lymphoma, high grade B-cell lymphoma with MYC/BCL2/BCL6 rearrangement, high grade B-cell lymphoma non-specific, primary mediastinal large B-cell lymphoma, or grade 3b follicular lymphoma
- Expected survival time of at least 12 weeks
- Presence of measurable target lesions by imaging: lymph node lesions 15 mm or larger, or extranodal lesions larger than 10 mm
- Laboratory values meeting specified thresholds for neutrophils, lymphocytes, hemoglobin, platelets, bilirubin, liver enzymes, and kidney function
- Good lung function with fingertip pulse oxygen saturation of 92% or higher without oxygen support
- Eastern Oncology Collaborative Group (ECOG) physical fitness score of 0 or 1
- No central nervous system lymphoma on head MRI
- Cardiac ultrasound showing left ventricular ejection fraction of 50% or higher, no significant abnormal ECG findings, and no significant pericardial or pleural effusion
- Adequate venous access for blood cell collection and no contraindications for blood cell separation
- Negative blood pregnancy test for females of childbearing potential during screening
You will not qualify if you...
- History of allergies to any components of cellular products
- History of allogeneic hematopoietic stem cell transplantation
- History of organ transplantation
- Positive tests for hepatitis B surface antigen or e antigen, hepatitis C virus antibody with high viral load, HIV antibody, Treponema pallidum antibody, cytomegalovirus DNA, or Epstein-Barr virus DNA above normal limits
- Clinically significant central nervous system diseases such as epilepsy, paralysis, strokes, severe brain injury, dementia, Parkinson's disease, cerebellar disorders, organic brain syndrome, or mental illness
- Active primary or secondary central nervous system lymphoma
- Previous treatment with other genetically modified T cell therapies, CAR-T therapies, or CD19-targeted therapies
- Severe genetic or autoimmune diseases like systemic lupus erythematosus
- Thromboembolic events within the last 6 months
- Malignant tumors other than those specified in the last 5 years except certain in situ or non-melanoma skin cancers
- Active or uncontrolled infections requiring systemic treatment
- Recent treatments prior to PBMC collection including certain chemotherapies, immunosuppressive therapies, radiotherapy, or cell growth factors within specified time frames
- Recent platelet transfusion within 7 days before screening
- Pregnant or breastfeeding women or those unwilling to use contraception during and for 2 years after treatment
- Participation in other clinical drug trials within 4 weeks prior to PBMC collection
- Investigator judgment of unsuitability for the trial such as poor compliance or drug abuse
- Recent or expected need for live or attenuated vaccines within or during the trial period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
Actively Recruiting
Research Team
L
lugui Qiu, MD
CONTACT
D
dehui Zou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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