Actively Recruiting
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
Led by Zhejiang University · Updated on 2020-10-28
120
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
Y
Yake Biotechnology Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.
CONDITIONS
Official Title
CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of CD19+ acute lymphoblastic leukemia, CD19+ non-Hodgkin's lymphoma, or BCMA+ multiple myeloma according to NCCN guidelines (2020.v2)
- Relapsed or refractory B cell blood cancers meeting at least one of the following: no complete remission after standard chemotherapy; complete remission lasting less than 12 months after first induction; ineffective after one or more remedial treatments; two or more relapses; relapse after stem cell transplantation; or extramedullary lesions not responding to radiotherapy or chemotherapy
- Total bilirubin less than or equal to 51 umol/L, ALT and AST less than or equal to three times the normal limit, creatinine less than or equal to 176.8 umol/L
- Left ventricular ejection fraction of 50% or higher on echocardiogram
- No active lung infection and blood oxygen saturation of 92% or higher indoors
- Estimated survival time of at least 12 weeks
- ECOG performance status between 0 and 2
- Women of childbearing age with negative pregnancy test before treatment and agreeing to use effective contraception for at least one year after infusion
- Voluntary agreement to participate and signing of informed consent
You will not qualify if you...
- History of brain injury, loss of consciousness, epilepsy, cerebrovascular ischemia, or hemorrhagic diseases
- Severe heart diseases such as severe arrhythmia or prolonged QT interval on ECG
- Pregnant or breastfeeding women
- Severe active infections, excluding simple urinary tract infection or bacterial pharyngitis
- Active hepatitis B or C infection
- Systemic steroid therapy within two weeks before screening, except recent or current inhaled steroids
- Previous treatment with any CAR-T cell or genetically modified T cell therapy
- Creatinine greater than 2.5 mg/dl, ALT or AST more than three times normal, or bilirubin greater than 2.0 mg/dl
- Other uncontrolled diseases unsuitable for the trial
- HIV infection
- Any other condition that the investigator believes may increase risk or affect study results
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, PhD
CONTACT
Y
Yongxian Hu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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