Actively Recruiting
A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies
Led by He Huang · Updated on 2020-08-21
100
Participants Needed
1
Research Sites
521 weeks
Total Duration
On this page
Sponsors
H
He Huang
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies.
CONDITIONS
Official Title
A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 3 to less than 70 years old
- Histologically confirmed diagnosis of CD19-positive B-cell acute lymphoblastic leukemia (B-ALL) or specific types of lymphoma according to standard classification criteria
- Relapsed or refractory disease meeting defined criteria such as lack of remission after chemotherapy or multiple recurrences
- Bone marrow with more than 5% lymphoblast and prolymphocyte cells by morphology and/or more than 1% by flow cytometry (for B-ALL)
- Philadelphia-chromosome negative patients, or Philadelphia-chromosome positive patients intolerant or nonresponsive to two tyrosine kinase inhibitor treatments (for B-ALL)
- At least one evaluable tumor lesion per Lugano 2014 criteria (for lymphoma)
- Negative or donor-specific antibody negative for HLA antibodies
- Total bilirubin less than or equal to 51 µmol/L; ALT and AST less than or equal to three times the upper limit of normal; creatinine less than or equal to 176.8 µmol/L
- Left ventricular ejection fraction equal to or greater than 50%
- No active lung infection and blood oxygen saturation equal to or greater than 92%
- Estimated survival time of at least 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Patients or legal guardians willing to provide informed consent
You will not qualify if you...
- Presence of extramedullary lesions except effectively controlled CNS lymphoma (for acute lymphoblastic leukemia patients)
- Diagnosis of lymphoblastic crisis of chronic myeloid leukemia or Burkitt's leukemia/lymphoma (for acute lymphoblastic leukemia patients)
- Hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other known bone marrow failure syndromes (for acute lymphoblastic leukemia patients)
- Intracranial extralateral lesions shown by MRI (for lymphoma patients)
- Extensive gastrointestinal lymphoma involvement (for lymphoma patients)
- Radiotherapy, chemotherapy, or monoclonal antibody therapy within one week prior to screening
- History of allergy to components in the cell therapy product
- Prior treatment with any CAR T-cell or genetically modified T-cell therapies
- Heart failure classified as New York Heart Association (NYHA) class III or IV
- Recent severe cardiac events or severe cardiac diseases within 12 months prior to enrollment
- Severe hypertension grade 3 or higher
- Severe arrhythmia or prolonged QT interval on electrocardiogram
- History of significant neurological conditions including trauma, epilepsy, or cerebrovascular diseases
- Severe active infections excluding simple urinary tract infection or bacterial pharyngitis
- Presence of indwelling catheters excluding certain central venous access devices
- History of other primary cancers except certain cured non-melanoma skin cancers or localized cancers with disease-free survival over two years
- Autoimmune diseases requiring treatment or immunodeficiency conditions
- Graft-versus-host disease
- Immunization with live vaccine within four weeks prior to screening
- History of alcoholism, drug abuse, or mental illness
- Active hepatitis B or other specified infections above defined thresholds
- Systemic steroid therapy within one week prior to screening except inhaled steroids
- Participation in other clinical trials within two weeks prior to screening
- Pregnancy, breastfeeding, or inability to use effective contraception
- Any other condition that might increase patient risk or interfere with study results as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Hospital of Zhejiang Medical Colleage Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
Research Team
H
He Huang, MD
CONTACT
Y
Yongxian Hu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here