CD19 CAR and PD-1 Knockout Engineered T Cells for CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
NCT ID: NCT03298828
Last Updated: 2017-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2017-11-30
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CD19 CAR
Patients meeting the eligibility criteria will have leukapheresis to isolate the blood immune cells used to manufacture the CD19 CAR T-cells. Patients will receive lymphodepletion with fludarabine and cyclophosphamide prior to infusion of the CD19 CAR T-cells.
CD19 CAR T-cells
A single dose of 1 x 10\^6/kg CD19 CAR transduced T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
CD19 CAR and PD-1 knock out
Patients meeting the eligibility criteria will have leukapheresis to isolate the blood immune cells used to manufacture the CD19 CAR and PD-1 knock out engineered T-cells. Patients will receive lymphodepletion with fludarabine and cyclophosphamide prior to infusion of the CD19 CAR and PD-1 knock out engineered T-cells.
CD19 CAR and PD-1 knock out engineered T-cells
A single dose of 1 x 10\^6/kg CD19 CAR transduced and PD-1 knock out engineered T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
Interventions
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CD19 CAR and PD-1 knock out engineered T-cells
A single dose of 1 x 10\^6/kg CD19 CAR transduced and PD-1 knock out engineered T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
CD19 CAR T-cells
A single dose of 1 x 10\^6/kg CD19 CAR transduced T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
Eligibility Criteria
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Inclusion Criteria
1. Resistant disease (\>25% blasts) at end of UKALL 2011 or equivalent induction
2. ALL with persistent high level MRD at 2nd time point of frontline national protocol (currently \> 5 x 10-3 at week 14 UKALL2011 or equivalent)
3. High risk infant ALL (age \< 6 months at diagnosis with MLL gene rearrangement and either presenting white cell count \> 300 x 109/L or poor steroid early response (i.e circulating blast count \>1x109/L following 7 day steroid pre- phase of Interfant 06)
4. Intermediate risk infant ALL with MRD \> 10-3 at end of Interfant06 induction
5. Very early (\< 18 months from diagnosis) bone marrow or extramedullary relapse of acute lymphoblastic leukaemia (ALL)
6. Early (within 6 months of finishing therapy) bone marrow, or combined extramedullary relapse of ALL with bone marrow minimal residual disease (MRD) \> 10-3 at end of re-induction
7. Any on therapy relapse of ALL in patients age 16-70
8. Any relapse of infant ALL
9. ALL post ≥ 2nd relapse
10. Any refractory relapse of ALL
11. ALL with MRD \>10-4 prior to planned stem cell transplant
12. Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant
13. Any relapse of ALL after stem cell transplant
14. Any relapse of Burkitt's or other CD19+ lymphoma
* 2.Agreement to have a pregnancy test, use adequate contraception (if applicable)
* 3.Written informed consent
Exclusion Criteria
2. Active hepatitis B, C or HIV infection
3. Oxygen saturation ≤ 90% on air
4. Bilirubin \> 3 x upper limit of normal
5. Creatinine \> 3 x upper limit of normal
6. Women who are pregnant or lactating
7. Stem Cell Transplant patients only: active acute graft-versus-host disease (GVHD) overall Grade ≥ II (Seattle criteria) or moderate/severe chronic GVHD (NIH consensus criteria) requiring systemic steroids
8. Inability to tolerate leucapheresis
9. Karnofsky (age ≥ 10 years) or Lansky (age \< 10) score ≤ 50%
1. Severe intercurrent infection at the time of scheduled CD19 CAR and PD-1 Knockout Engineered T Cells infusion
2. Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19 CAR and PD-1 Knockout Engineered T Cells infusion
3. Allogeneic transplant recipients with active acute GVHD overall grade \>2 or moderate/severe chronic GVHD requiring systemic steroids at the time of scheduled CD19 CAR and PD-1 Knockout Engineered T Cells infusion
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Xiaoyun Shang
Principal Investigator
Central Contacts
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Other Identifiers
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TMMU-CAR-001
Identifier Type: -
Identifier Source: org_study_id