Status:
COMPLETED
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
Lead Sponsor:
UWELL Biopharma
Collaborating Sponsors:
Liaocheng People's Hospital
Conditions:
Lymphoma Leukemia
Eligibility:
All Genders
Up to 70 years
Phase:
NA
Brief Summary
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Curre...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03811457
Start Date
June 1 2017
End Date
December 31 2018
Last Update
January 22 2019
Active Locations (1)
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1
Liaocheng People Hospital
Liaocheng, Shandong, China, 252000