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CompletedNCT03289455AMELIAUpdated Feb 1, 2021Results posted

CD19 /22 CAR T Cells (AUTO3) for the Treatment of B Cell Acute Lymphoblastic Leukemia (ALL)

A Phase 1/2 interventional study of AUTO3 (CD19/22 CAR T cells in B Acute Lymphoblastic Leukemia, Recurrent Childhood Acute Lymphoblastic Leukemia and Refractory Childhood Acute Lymphoblastic Leukemia, sponsored by Autolus Limited. Completed at 3 sites in United Kingdom. Open to participants aged 1 Year to 24 Years. Per ClinicalTrials.gov, last updated 2021-02-01.

Sponsored by Autolus Limited · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
1 Year to 24 Years
Sex
All
01

Study summary

The purpose of this study is to test the safety and efficacy of AUTO3, a CAR T cell treatment targeting CD19 and CD22 in paediatric or young adult patients with relapsed or refractory B cell acute lymphoblastic leukaemia.

Read the detailed description

The study will consist of 2 phases, a Phase I or dose escalation phase and a Phase II or expansion phase. Paediatric or young adult patients with relapsed or refractory B cell ALL will be enrolled in both phases of the study. Eligible patients will undergo leukapheresis in order to harvest T cells, which is the starting material for the manufacture of the autologous CAR T product AUTO3 which is a CD19 and CD22 dual targeting CAR T cell product. Following pre-conditioning by a chemotherapeutic regimen, the patient will receive AUTO3 intravenously as a single or split dose and will then enter a 24-month follow-up period.

02

Conditions studied

  • B Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Refractory Childhood Acute Lymphoblastic Leukemia
  • B-cell Acute Lymphoblastic Leukemia

Keywords

  • Acute Lymphoblastic Leukaemia
  • CD19 Positive
  • CD22 Positive
  • Relapsed Acute Lymphoblastic Leukaemia
  • Refractory Acute Lymphoblastic Leukaemia
  • AUTO3
03

Who can participate

Ages eligible
1 Year to 24 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Male or female patients aged 1-24 years with high risk (HR) relapsed/refractory B-lineage ALL, AND:

    1. Any bone marrow (BM) relapse or central nervous system (CNS) relapse with detectable BM disease after allogeneic stem cell transplant (SCT) and must be ≥6 months from SCT at the time of AUTO3 infusion; OR,
    2. HR first relapse; OR,
    3. Standard risk relapse patients with HR cytogenetics; OR,
    4. Second or greater relapse; OR,
    5. BM minimal residual disease (MRD) ≥10-³ prior to planned SCT; OR,

    6. Any on-treatment relapse in patients aged 16-24 years.

      (Phase II Only - Criteria in addition to those described above:)

    7. Primary refractory disease; OR,
    8. Patients with Philadelphia chromosome positive ALL are eligible if they are intolerant to or have failed 2 lines of tyrosine kinase inhibitor (TKI) therapy, or if TKI therapy is contraindicated; OR,
    9. Isolated CNS relapse but with ≤CNS Grade 2 disease at time of enrolment.
  2. Documentation of CD19 and or CD22 expression on leukaemic blasts in the BM, peripheral blood, or cerebrospinal fluid within 3 months of screening.
  3. Detectable disease in the BM at a level ≥10-⁴ (Phase I only).
  4. Absolute lymphocyte count ≥0.5 x 10⁹/L.
  5. Adequate renal, hepatic, pulmonary, and cardiac function.
  6. Karnofsky (age ≥10 years) or Lansky (age \<10 years) score ≥50%.
  7. Willing and able to give written, informed consent to the current study (patient and/or parent or legal guardian).

Exclusion Criteria:

  1. Isolated extra-medullary disease relapse.
  2. Active CNS involvement of ALL (CNS Grade 3 per National Comprehensive Cancer Network guidelines).
  3. Active infectious bacterial or viral disease requiring IV anti-microbials for treatment.
  4. Females who are pregnant or lactating.
  5. Females of child-bearing potential and post pubertal male participants who are unwilling to use highly effective methods of contraception for a period of 1 year after the AUTO3 infusion.
  6. Inability to tolerate leukapheresis.
  7. Prior CD19 or CD22 targeted therapy with Grade 4 toxicity or ≥refractory Grade 3 cytokine release syndrome (CRS) or ≥Grade 3 drug related CNS toxicity.
  8. Pre-existing significant neurological disorder.
  9. Stem Cell Transplant patients only: active significant acute graft versus host disease (GVHD) or moderate/severe chronic GVHD requiring systemic steroids or other immunosuppressant within 4 weeks of enrolment.

  10. The following medications are excluded:

    1. Steroids: Therapeutic doses of steroids must be stopped >72 hours prior to AUTO3 infusion and leukapheresis. However, physiological replacement doses of steroids are allowed: \<12 mg/m2/day hydrocortisone or equivalent.
    2. Allogeneic cellular therapy: Any donor lymphocyte infusions must be completed >6 weeks prior to AUTO3 infusion.
    3. Graft versus host disease therapies: Any drug used for GVHD must be stopped >4 weeks prior to AUTO3 infusion.
    4. Chemotherapy: Should be stopped 1 week prior to leukapheresis and 2 days prior to starting pre-conditioning chemotherapy.
  11. Known allergy to albumin, dimethyl sulfoxide, cyclophosphamide or fludarabine.

For AUTO3 Infusion: Patients meeting any of the following exclusion criteria will not be treated with AUTO3 or treatment will be delayed until they no longer meet these criteria:

  1. Severe intercurrent infection.
  2. Requirement for supplementary oxygen.
  3. Allogeneic transplant recipients with active significant acute GVHD overall Grade ≥II or moderate/severe chronic GVHD requiring systemic steroids.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    AUTO3

    Paediatric patients with relapse or refractory B-cell ALL

    Biological: AUTO3 (CD19/22 CAR T cells

Interventions

  • BiologicalAUTO3 (CD19/22 CAR T cells

    Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 1 to 5.0 x 10⁶/kg CD19/CD22 Chimeric Antigen Receptor (CAR) positive T cells as a single or split dose.

05

What researchers measure

Primary outcomes

  1. Number of Patients With Grade 3-5 Toxicities Occurring Within the Dose Limiting Toxicity (DLT) Period of AUTO3 Infusion

    Time frame: Within 30 days (+/- 3 days) after the last dose of AUTO3.

  2. Number of Patients With Dose Limiting Toxicity (DLT) of AUTO3

    DLT was defined as i) any new non-hematological adverse event (AE) of Grade 3 or higher toxicity using the NCI CTCAE (version 5.0), which was probably or definitely related to AUTO3 therapy, which occurred within the DLT evaluation period, and which failed to resolve to Grade 2 or better within 14 days, despite appropriate supportive measures; ii) Grade 4 cytokine release syndrome (CRS) or neurotoxicity, cerebral edema, or Grade 3 neurotoxicity (including cerebral edema) that lasted \>72 hours; iii) Grade \>3 disseminated intravascular coagulation; iv) Grade \>2 infusion reaction; v) Any other fatal event (Grade 5) or life-threatening event (Grade 4) that could not be managed with conventional supportive measures or which in the opinion of the Safety Evaluation Committee (SEC) necessitated dose reduction or other modification to trial treatment to avoid a similar hazard in future patients.

    Time frame: Within 30 days (+/- 3 days) after the last dose of AUTO3.

  3. Number of Patients Achieving Morphological Remission (Complete Response(CR) or Complete Response With Incomplete Count Recovery (CRi) and Minimal Residual Disease (MRD)-Negative Response in the Bone Marrow (PCR)).

    Morphological response evaluations were based on the response criteria for ALL according to the NCCN guidelines version 2.2014. Minimal residual disease-negative status was achieved if MRD was \<10\^-4 (0.01%) by PCR amplification of individual rearrangements of Ig genes and/or flow cytometry MRD testing.

    Time frame: Within 30 days (+/- 3 days) post AUTO3 infusion

Secondary outcomes

  1. Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis

    Feasibility of product generation was examined by assessing the number of AUTO3 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients screened).

    Time frame: Up to 8 weeks post leukapheresis

  2. Event-Free Survival (EFS) by Morphological Analysis

    Time from date of first AUTO3 infusion until the earliest of treatment failure (defined as not achieving CR/CRi post AUTO3 infusion / no response), morphological relapse, or death due to any cause, whichever occurred first.

    Time frame: Up to 2 years

  3. Number of Patients With CD19- and/or CD22-negative Relapse

    Time frame: Up to 2 years

  4. Relapse-Free Survival (RFS) by Morphological Analysis

    Time from first achievement of morphological CR/CRi post AUTO3 treatment until the earliest of morphological relapse, or death due to any cause, whichever occurred first.

    Time frame: Up to 2 years

  5. Overall Survival (OS)

    Calculated from the date of AUTO3 treatment to the date of death anytime post AUTO3 infusion. Patients who had not died were censored at the date of last contact.

    Time frame: Up to 2 years after the last patient was infused

  6. Expansion of AUTO3 Following Adoptive Transfer

    Expansion of AUTO3 was measured as the median peak (Cmax) of transgene levels in the peripheral blood after AUTO3 infusion

    Time frame: Up to 2 years

  7. Persistence of AUTO3 Following Adoptive Transfer

    Persistence of AUTO3 was measured by quantitative polymerase chain reaction (qPCR) and/or flow cytometry at a range of time points in the peripheral blood and the bone marrow. Persistence was defined as the timepoint in days of last detectable CAR T cell by qPCR or last assessment if zero copies per μg DNA (whichever occurred later) before morphological relapse (Tlast).

    Time frame: Up to 2 years

  8. Duration of B Cell Aplasia

    Depletion of circulating B cells assessed by flow cytometry at a range of time points in the peripheral blood

    Time frame: Up to 2 years

06

Results

Posted Feb 1, 2021
Limitations and caveats
Early completion of the study leading to small numbers of patients analyzed from the Phase I part of the study.

Participant flow

Participant flow — Overall Study
Milestone1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Started456
Completed000
Not completed456
Withdrew: Death100
Withdrew: Sponsor decision due to covid19 restrictions010
Withdrew: No cart persistence in mrd negativity. patient proceeded with hsct001
Withdrew: Progressive disease345

Outcome measures

PrimaryNumber of Patients With Grade 3-5 Toxicities Occurring Within the Dose Limiting Toxicity (DLT) Period of AUTO3 Infusion
Time frame:
Within 30 days (+/- 3 days) after the last dose of AUTO3.
Reported as:
Count of participants · Participants
Number of Patients With Grade 3-5 Toxicities Occurring Within the Dose Limiting Toxicity (DLT) Period of AUTO3 Infusion
Participants1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Number of Patients With Grade 3-5 Toxicities Occurring Within the Dose Limiting Toxicity (DLT) Period of AUTO3 Infusion446
PrimaryNumber of Patients With Dose Limiting Toxicity (DLT) of AUTO3

DLT was defined as i) any new non-hematological adverse event (AE) of Grade 3 or higher toxicity using the NCI CTCAE (version 5.0), which was probably or definitely related to AUTO3 therapy, which occurred within the DLT evaluation period, and which failed to resolve to Grade 2 or better within 14 days, despite appropriate supportive measures; ii) Grade 4 cytokine release syndrome (CRS) or neurotoxicity, cerebral edema, or Grade 3 neurotoxicity (including cerebral edema) that lasted \>72 hours; iii) Grade \>3 disseminated intravascular coagulation; iv) Grade \>2 infusion reaction; v) Any other fatal event (Grade 5) or life-threatening event (Grade 4) that could not be managed with conventional supportive measures or which in the opinion of the Safety Evaluation Committee (SEC) necessitated dose reduction or other modification to trial treatment to avoid a similar hazard in future patients.

Time frame:
Within 30 days (+/- 3 days) after the last dose of AUTO3.
Reported as:
Count of participants · Participants
Number of Patients With Dose Limiting Toxicity (DLT) of AUTO3
Participants1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Number of Patients With Dose Limiting Toxicity (DLT) of AUTO3000
PrimaryNumber of Patients Achieving Morphological Remission (Complete Response(CR) or Complete Response With Incomplete Count Recovery (CRi) and Minimal Residual Disease (MRD)-Negative Response in the Bone Marrow (PCR)).

Morphological response evaluations were based on the response criteria for ALL according to the NCCN guidelines version 2.2014. Minimal residual disease-negative status was achieved if MRD was \<10\^-4 (0.01%) by PCR amplification of individual rearrangements of Ig genes and/or flow cytometry MRD testing.

Time frame:
Within 30 days (+/- 3 days) post AUTO3 infusion
Reported as:
Count of participants · Participants
Number of Patients Achieving Morphological Remission (Complete Response(CR) or Complete Response With Incomplete Count Recovery (CRi) and Minimal Residual Disease (MRD)-Negative Response in the Bone Marrow (PCR)).
Participants1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Number of Patients Achieving Morphological Remission (Complete Response(CR) or Complete Response With Incomplete Count Recovery (CRi) and Minimal Residual Disease (MRD)-Negative Response in the Bone Marrow (PCR)).355
SecondaryFeasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis

Feasibility of product generation was examined by assessing the number of AUTO3 successfully manufactured as a fraction of the number of patients undergoing leukapheresis (all patients screened).

Time frame:
Up to 8 weeks post leukapheresis
Reported as:
Count of participants · Participants
Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis
ParticipantsAUTO3
Feasibility of Generating AUTO3: Number of Patients' Cells Successfully Manufactured as a Proportion of the Number of Patients Undergoing Leukapheresis19
SecondaryEvent-Free Survival (EFS) by Morphological Analysis

Time from date of first AUTO3 infusion until the earliest of treatment failure (defined as not achieving CR/CRi post AUTO3 infusion / no response), morphological relapse, or death due to any cause, whichever occurred first.

Time frame:
Up to 2 years
Reported as:
Median · months
Event-Free Survival (EFS) by Morphological Analysis
months1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Event-Free Survival (EFS) by Morphological Analysis3.48 (0.03 to NA)12.42 (3.94 to NA)2.79 (0.03 to NA)
SecondaryNumber of Patients With CD19- and/or CD22-negative Relapse
Time frame:
Up to 2 years
Reported as:
Count of participants · Participants
Number of Patients With CD19- and/or CD22-negative Relapse
Participants1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Number of Patients With CD19- and/or CD22-negative Relapse021
SecondaryRelapse-Free Survival (RFS) by Morphological Analysis

Time from first achievement of morphological CR/CRi post AUTO3 treatment until the earliest of morphological relapse, or death due to any cause, whichever occurred first.

Time frame:
Up to 2 years
Reported as:
Median · months
Relapse-Free Survival (RFS) by Morphological Analysis
months1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Relapse-Free Survival (RFS) by Morphological Analysis6.09 (2.56 to NA)11.50 (3.02 to NA)3.98 (1.87 to NA)
SecondaryOverall Survival (OS)

Calculated from the date of AUTO3 treatment to the date of death anytime post AUTO3 infusion. Patients who had not died were censored at the date of last contact.

Time frame:
Up to 2 years after the last patient was infused
Reported as:
Median · months
Overall Survival (OS)
months1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Overall Survival (OS)10.17 (2.30 to NA)25.20 (4.34 to NA)NA (4.07 to NA)
SecondaryExpansion of AUTO3 Following Adoptive Transfer

Expansion of AUTO3 was measured as the median peak (Cmax) of transgene levels in the peripheral blood after AUTO3 infusion

Time frame:
Up to 2 years
Reported as:
Median · vector copies/ug DNA
Expansion of AUTO3 Following Adoptive Transfer
vector copies/ug DNA1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Expansion of AUTO3 Following Adoptive Transfer10240 (5690 to 37000)102000 (34800 to 127000)79800 (13200 to 104000)
SecondaryPersistence of AUTO3 Following Adoptive Transfer

Persistence of AUTO3 was measured by quantitative polymerase chain reaction (qPCR) and/or flow cytometry at a range of time points in the peripheral blood and the bone marrow. Persistence was defined as the timepoint in days of last detectable CAR T cell by qPCR or last assessment if zero copies per μg DNA (whichever occurred later) before morphological relapse (Tlast).

Time frame:
Up to 2 years
Reported as:
Median · days
Persistence of AUTO3 Following Adoptive Transfer
days1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Persistence of AUTO3 Following Adoptive Transfer41.7 (19.8 to 256.8)343.7 (62.7 to 538.9)24.3 (18.8 to 570.8)
SecondaryDuration of B Cell Aplasia

Depletion of circulating B cells assessed by flow cytometry at a range of time points in the peripheral blood

Time frame:
Up to 2 years
Reported as:
Median · months
Duration of B Cell Aplasia
months1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
Duration of B Cell AplasiaNA (NA to NA)NA (NA to NA)NA (NA to NA)

Adverse events

Collected over From AUTO3 infusion (Day 0) until the end of study (2 years after last patient dosed) or withdrawal, whichever occurred first. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
1x10^6 CD19/CD22 CAR-positive T Cells/kg3/4 (75%)1/4 (25%)4/4 (100%)
3x10^6 CD19/CD22 CAR-positive T Cells/kg3/5 (60%)2/5 (40%)5/5 (100%)
5x10^6 CD19/CD22 CAR-positive T Cells/kg3/6 (50%)3/6 (50%)6/6 (100%)
Most frequent serious events
Most frequent serious events
Event1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
AnaemiaBlood and lymphatic system disorders0/41/52/6
NeutropeniaBlood and lymphatic system disorders0/41/52/6
ThrombocytopeniaBlood and lymphatic system disorders0/41/52/6
EncephalopathyNervous system disorders1/40/50/6
Febrile neutropeniaBlood and lymphatic system disorders0/41/51/6
PyrexiaGeneral disorders0/40/51/6
CellulitisInfections and infestations0/40/51/6
SeizureNervous system disorders0/40/51/6
Most frequent other events
Showing 10 of 68
Most frequent other events
Event1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kg
PyrexiaGeneral disorders1/43/55/6
VomitingGastrointestinal disorders1/40/54/6
AnaemiaBlood and lymphatic system disorders0/43/51/6
Decreased appetiteMetabolism and nutrition disorders0/43/52/6
Febrile neutropeniaBlood and lymphatic system disorders2/42/52/6
DiarrhoeaGastrointestinal disorders2/41/51/6
Neutrophil count decreasedInvestigations2/42/51/6
Pain in extremityMusculoskeletal and connective tissue disorders0/42/53/6
ParaesthesiaNervous system disorders2/41/50/6
NauseaGastrointestinal disorders1/42/52/6

Baseline characteristics

Patients infused with AUTO3

Age, Categorical
Age, Categorical(Participants)1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kgTotal
<=18 years45615
Between 18 and 65 years0000
>=65 years0000
Sex: Female, Male
Sex: Female, Male(Participants)1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kgTotal
Female0224
Male43411
Race (NIH/OMB)
Race (NIH/OMB)(Participants)1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kgTotal
American Indian or Alaska Native0000
Asian1001
Native Hawaiian or Other Pacific Islander0000
Black or African American0000
White35614
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kgTotal
United Kingdom45615
Karnofsky/Lansky score
Karnofsky/Lansky score(percentage)1x10^6 CD19/CD22 CAR-positive T Cells/kg3x10^6 CD19/CD22 CAR-positive T Cells/kg5x10^6 CD19/CD22 CAR-positive T Cells/kgTotal
Median95 (80 to 100)90 (80 to 100)100 (90 to 100)90 (80 to 100)
07

Study locations

3 sites
  • Great Ormond Street Hospital for Children NHS Foundation Trust
    London, United Kingdom
  • University College London Hospitals NHS Foundation Trust
    London, United Kingdom
  • Royal Manchester Children's Hospital
    Manchester, United Kingdom
08

References and documents

Study documents

  • Study protocol · May 10, 2019
  • Statistical analysis plan · Jul 30, 2020

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT03289455
Lead sponsor
Autolus Limited
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Jun 26, 2017
Primary completion
May 18, 2020
Completion
May 18, 2020
Results posted
Feb 1, 2021
Last update
Feb 1, 2021

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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