Relapsed/ refractory B- cell acute lymphoid leukaemia
Conditions
Interventions
Product Name: TT52CAR19
Pharmaceutical Form: Infusion
INN or Proposed INN: CAR19+TCRaß- T cells
Other descriptive name: TT52CAR19
Concentration unit: Other
Concentration type: equal
Concentration numb
Sponsors
Great Ormond Street Hospital for Children NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Demographic characteristics 1. Male or female patients 2. Age ranging between 6 months and =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Patients/parents unwilling to undergo follow-up • Foreseeable poor compliance to the study procedures • CD19-negative B-cell leukaemia • Evidence of disease progression after cytoreduction • Uncontrolled CNS leukeamia or neurological symptoms • Absence of suitable HLA matched or mismatched donor • Weight 0.5mg/kg/day • Known hypersensitivity to any of the test materials or related compounds • Uncontrolled systemic bacterial, fungal, protozoal or viral infection • Risk of pregnancy or non compliance with contraception (if applicable). Girls of childbearing potential must have been tested negative in a pregnancy test within 7 days prior to inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objective is to determine if TT52CAR19 can mediate molecular remission by day 28 and thereby allow patients to proceed to allo-SCT. In addition, there are some exploratory objectives: • Assess the time to remission, frequency and duration of remission • Assess the overall survival, and progression free survival. • Assess the immune recovery after TT52CAR19 and after allo-SCT • Determine the frequency of GVHD • Determine the frequency of viral reactivation (CMV, ADV, EBV) • Track the expansion, persistence and elimination of TT52CART19 • Assess cytokine, ferritin and C-reactive protein levels. • Screen for anti-HLA antibody responses. • Assess B cell recovery • Assess CD19, CD20, CD22 and CD52 expression on leukaemic cells • Archive samples for RCL. • Monitor DNA signatures of genomic editing in TT52CAR19 ;Primary end point(s): The primary objective is to assess safety of TT52CAR19 in paediatric patients with relapsed /refractory B-ALL. This will be evaluated by: • Clinical examination • Measurement of vital signs (blood pressure, heart rate, temperature, respiratory rate) • Measurement of standard haematology, biochemistry and coagulation parameters • Measurement of oxygen saturation • ECG and ECHO if indicated • Measurement of Cytokines, Ferritin and CRP levels • Viral / bacterial / protozoal infection monitoring National Cancer Institute Common Toxicity Criteria for Adverse Event (version V4.3 June 14, 2010) will be used to grade events. Specialized grading scales for CRS and GVHD will be applied.;Main Objective: The primary objective of the study is to evaluate the safety of TT52CAR19 cell therapy in children with relapsed or refractory B acute lymphoblastic leukaemia (B-ALL).;Timepoint(s) of evaluation of this end point: These primary end points will be evaluated at day 28 post TTCAR19 infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective is to determine if TTCAR19 can mediate molecular remission by day 28 and thereby allow patients to proceed to allo-SCT. There are additional exploratory objectives: • Assess the time to remission, frequency and duration of remission • Assess the overall survival, and progression free survival. • Assess the immune recovery after TTCAR19 and after allo-SCT • Determine the frequency of GVHD • Determine the frequency of viral reactivation (CMV, ADV, EBV) • Track the expansion, persistence and elimination of TTCART19 • Assess cytokine, ferritin and C-reactive protein levels. • Screen for anti-HLA antibody responses. • Assess B cell recovery • Assess CD19, CD20, CD22 and CD52 expression on leukaemic cells • Archive samples for RCL. • Monitor DNA signatures of genomic editing in TTCAR19 ;Timepoint(s) of evaluation of this end point: These secondary end points will be evaluated at day 28 post TTCAR19 infusion. | — |
Countries
United Kingdom
Outcome results
None listed