Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT03811457
Eligibility Criteria:
Inclusion Criteria:
* CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies
* Absolute lymphocyte count, ALC )≧600/μl
* HIV, HTLV, Syphilis negative
* GPT ≦200 U/L
* Cr ≦221 umol/L
* Adequate venous access for apheresis, and no other contraindications for leukapheresis.
* Voluntary informed consent is given.
Exclusion Criteria:
* Body weight \< 20Kg
* Pregnant women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
* Previously treatment with any gene or cell therapy products.
* Any uncontrolled active medical disorder that would preclude participation as outlined.
* Expected survival\< 12 weeks
* Received investigational drug or device within 30 days pre-trial;
* Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
70 Years
Study:
NCT03811457
Study Brief:
Protocol Section:
NCT03811457