NCT04012892UnknownPhase 1
Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Chinese PLA General Hospital1 site in 1 country12 target enrollmentStarted: May 1, 2019Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- recovery rate of patients being treated with CD19CAR-T
Study Overview
Brief Summary
This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
- •Age 18 to 65 years old, both male and female;
- •Is expected to survive more than 12 weeks;
- •Physical condition is good: 0-1 score ECOG score;
- •No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
- •Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.
Exclusion Criteria
- •Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
- •Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
- •Pregnancy and lactation women;
- •Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
- •The Investigator believe the patients should not participate in this experiment.
Arms & Interventions
study group
Experimental
After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours
Intervention: CD19 CART (Combination Product)
Outcomes
Primary Outcomes
recovery rate of patients being treated with CD19CAR-T
Time Frame: 6 months
the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T
Secondary Outcomes
No secondary outcomes reported
Investigators
Li Yu
Professor
Chinese PLA General Hospital
Study Sites (1)
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