Status:
UNKNOWN
CD19 CAR and PD-1 Knockout Engineered T Cells for CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
Lead Sponsor:
Third Military Medical University
Conditions:
Acute Lymphoblastic Leukemia
Burkitt Lymphoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, efficacy and blood kinetics of autologous T cells genetically modified to express CD19 Chimeric Antigen Receptor and PD-1 knockout engineered T cel...
Detailed Description
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) and PD-1 knock out enginee...
Eligibility Criteria
Inclusion
- Children and adults (age 70 years or younger) with high risk/relapsed CD19+ haematological malignancy:
- Resistant disease (\>25% blasts) at end of UKALL 2011 or equivalent induction
- 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)
- 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)
- Intermediate risk infant ALL with MRD \> 10-3 at end of Interfant06 induction
- Very early (\< 18 months from diagnosis) bone marrow or extramedullary relapse of acute lymphoblastic leukaemia (ALL)
- 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
- Any on therapy relapse of ALL in patients age 16-70
- Any relapse of infant ALL
- ALL post ≥ 2nd relapse
- Any refractory relapse of ALL
- ALL with MRD \>10-4 prior to planned stem cell transplant
- Any relapse of ALL eligible for stem cell transplant but no available HLA matched donor or other contraindication to transplant
- Any relapse of ALL after stem cell transplant
- Any relapse of Burkitt's or other CD19+ lymphoma
- Agreement to have a pregnancy test, use adequate contraception (if applicable)
- Written informed consent
Exclusion
- Exclusion Criteria for registration:
- CD19 negative disease
- Active hepatitis B, C or HIV infection
- Oxygen saturation ≤ 90% on air
- Bilirubin \> 3 x upper limit of normal
- Creatinine \> 3 x upper limit of normal
- Women who are pregnant or lactating
- 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
- Inability to tolerate leucapheresis
- Karnofsky (age ≥ 10 years) or Lansky (age \< 10) score ≤ 50%
- Exclusion criteria for CD19CAR T-cell infusion:
- Severe intercurrent infection at the time of scheduled CD19 CAR and PD-1 Knockout Engineered T Cells infusion
- Requirement for supplementary oxygen or active pulmonary infiltrates at the time of scheduled CD19 CAR and PD-1 Knockout Engineered T Cells infusion
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03298828
Start Date
November 1 2017
End Date
October 1 2022
Last Update
October 2 2017
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