ClinicalTrials.gg
RecruitingNCT07361029CD19 CART CELLUpdated Jan 22, 2026

CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia

A Phase 1 interventional study of CAR T cells chimeric antigen receptor cells in Relapsed Refractory Acute Lymphoblastic Leukemia, sponsored by King Faisal Specialist Hospital & Research Center. Recruiting at 1 site in Saudi Arabia. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by King Faisal Specialist Hospital & Research Center · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).

Read the detailed description

Approximately 24 patients are planned to be enrolled in four cohorts during the dose-escalation stage. Within each cohort, 3 patients will receive treatment with CD19 CAR T cells.

The starting dose level is 5x10*5cells/kg, administered as a single dose by IV infusion. Dose escalation will proceed in accordance with the dose-escalation Dose-escalation decisions will be made by the Data Safety Monitoring Board (DSMB) in consultation with the investigators . CD19 CAR T cells administration between the first and second patient in each dose level will be separated by a minimum of 4 weeks. CD19 CAR T cells administration between each subsequent patient in a dose level will be separated by a minimum of 2 weeks.

02

Conditions studied

  • Relapsed Refractory Acute Lymphoblastic Leukemia

Keywords

  • CD19 CAR T
  • relapsed/refractory acute lymphoblastic leukemia (ALL).
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,584 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 473 are open to participants now.

This study's planned enrollment of 24 is below the median of 40 across 1,952 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

King Faisal Specialist Hospital & Research Center is the lead sponsor of 99 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged between 18 to 75 years old (patients is older than 18.0 and less than 75.0 years old) 2. Signed form 3. Ability to comply with the study protocol 4. B-cell acute lymphoblastic leukemia (B-ALL):

    1. Second or greater bone marrow (BM) relapse; or
    2. Primary refractory, defined as not achieving complete remission (CR) after 2 cycles of a standard chemotherapy regimen, or Chemo-refractory, defined as not achieving CR after 1 cycle of standard chemotherapy for relapsed leukemia; or
    3. Philadelphia chromosome-positive ALL intolerant of or with 2 failed lines of tyrosine kinase inhibitor (TKI) therapy; or
    4. Relapsed patients ineligible for Stem Cell Transplant (AlloSCT) due to lack of a suitable donor.
    5. Relapsed after AlloSCT. at least 12 weeks after alloSCT or relapse happened after withdrawing the post-transplant
    6. Relapsed after prior CAR T cell and still CD19 positive. . (Patients with a history of ≥grade CRS, ≥ grade 3 ICANS, or severe reactions following prior CAR T-cell therapy should be excluded.) 5. BM with ≥5% lymphoblasts by morphologic assessment at screening 6. For relapsed patients, documentation of CD19 tumor expression in BM or peripheral blood by flow cytometry or immunohistochemistry within 1 month of study entry 7. Patients with a history of CNS or meningeal involvement must be in a documented clinical remission prior to registration.

      8. (ALT) ≤5 times the for age 9. ≤2 x ULN 10. Patients with good renal function defined as (as estimated by Cockcroft Gault) ≥ 60 cc/min.

      11. (ANC): Patients must have an ANC ≥ 1.0 x 109

      /L without the use of growth factors 12. Count: Patients must have a platelet count ≥ 50 x 109/L without transfusion support within 7 days of screening.

      13. Absolute Lymphocyte Count: Patients must have an absolute lymphocyte count ≥ 0.5 x 109/L.

      14. Definition of Adequate Organ Function:

      • Renal Function: (GFR) > 60mL/min.
      • Hepatic Function: AST/ALT ≤ 5 x ULN and bilirubin ≤ 2 x ULN. Total bilirubin 1.5 ULN (except Gilbert's syndrome).
      • Pulmonary Function: Adequate respiratory function defined as oxygen saturation ≥ 93% on room air.
      • Cardiac Function: (LVEF) ≥ 45% by echocardiogram or MUGA scan and ≤ 480 ms. 15. Minimum level of pulmonary reserve defined as grade ≤1 dyspnea and pulse oxygenation >93% on room air 16. Left ventricular ejection fraction ≥45% confirmed by echocardiogram within 30 days of screening 17. ≥ 70% and /or 0-2 at the time of screening 18. Women of child bearing age should have negative serum pregnancy test within 7 days prior to enrollment 19. If sexually active:

    <!-- -->

    1. Females should use effective 1 month prior to screening until 12 months after CAR T cell infusion
    2. Males to use condom for six months after infusion 20. Meet institutional criteria to undergo leukapheresis or have an acceptable, stored leukapheresis product

Exclusion criteria

Exclusion Criteria:

  1. Clinically Active central nervous system (CNS) involvement by
  2. History or presence of uncontrolled underlying seizure disorder not related to B-ALL
  3. History of or active cardiovascular dysfunction, including any of the following:

    • History of stroke within 24 months prior to the CD19 CAR T cells infusion or with ongoing sequelae
    • History of within 12 months prior to the CD19 CAR T cells infusion
    • History of myocardial infarction within 36 months prior to the CD19 CAR T cells infusion
    • Symptomatic congestive heart failure ( class III/IV), unstable angina pectoris, cardiac arrhythmia requiring therapy
    • Uncontrolled arrhythmias, or history of or active ventricular arrhythmia requiring medication
    • Active or history of coronary heart disease that remains symptomatic
    • Active or history of unstable or stable angina
    • (LVEF) \< 45% confirmed by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) scan
  4. \< 60
  5. Concomitant genetic syndromes associated with Bone Marrow (BM) failure states, such as Fanconi anemia, Kostmann syndrome, Schwachman syndrome, or any other BM failure syndrome; patients with Down syndrome are not excluded
  6. Burkitt lymphoma/leukemia
  7. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease
  8. Treatment with any prior gene therapy product (except prior CAR-T cell therapy)
  9. Positive test within 8 weeks of screening
  10. Serologic status reflecting active or C infection: Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded.)
  11. Received an medicinal product on trial within the 30 days prior to screening
  12. Pregnant
  13. Lactating
  14. Women of and all male participants, unless using highly effective methods of for 1 year after CAR-T infusion
  15. Therapeutic systemic doses of (>=0.5mg/kg prednisone equivalent) must be stopped >72 hours prior to lymphodepletion
  16. TKIs and hydroxyurea must be stopped >72 hours prior to lymphodepletion
  17. The following drugs must be stopped >1 week prior to lymphodepleting chemotherapy:

    vincristine, 6- mercaptopurine, 6-thioguanine, methotrexate 2 weeks prior to CART infusion: salvage chemotherapy (e.g., clofarabine, cytosine arabinoside >100 mg/m2

    , anthracyclines, cyclophosphamide, methotrexate ≥25 mg/m2

    ), excluding the required lymphodepleting chemotherapy drugs

  18. Pegylated asparaginase must be stopped >4 weeks prior to CAR T cell infusion
  19. CNS disease prophylaxis and/or intrathecal chemotherapy must be stopped >1 week prior to CAR T cell infusion
  20. Radiation therapy at non-CNS site must be completed >2 weeks prior to CAR T Cell infusion
  21. CNS-directed radiation must be completed >8 weeks prior to CAR T cell infusion
  22. Known History of severe allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study (including, but not limited to, cyclophosphamide and fludarabine used in the lymphodepleting chemotherapy, DMSO used as a cryoprotectant in the cell media, etc.)
  23. transplant within 6 weeks of planned CAR-T cell infusion
  24. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow prior to initiation of therapy.
  25. Primary Immunodeficiency Patients:

    • Patients with known primary immunodeficiency disorders are excluded due to increased risk of adverse outcomes.
  26. Recent Administration:

    • Patients who have received a live vaccine within 4 weeks prior to enrolment are excluded.
    • Additionally, vaccination with live vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    single arm dose finding

    Other: CAR T cells chimeric antigen receptor cells

Interventions

  • OtherCAR T cells chimeric antigen receptor cells

    CAR T Cells

06

What researchers measure

Primary outcomes

  1. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    To assess the maximum tolerated dose, safety and tolerability of intravenous infusion of CD19 CAR T cells using based on incidence, nature, and severity of AEs graded according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5 (NCI CTCAE v5), cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).

    Time frame: throughout study completion, Day1 to 5 years

Secondary outcomes

  1. Evaluate the success rate of product manufacturing

    To evaluate the success rate of product manufacturing based on product meeting release criteria

    Time frame: Pre-infusion

  2. preliminary anti-tumor activity of CD19 CAR T cells in treated patients

    Preliminary anti-tumor activity of CD19 CAR T post-infusion and Minimal residual disease (MRD) status at 1st-month and 2nd- month post-infusion in treated patient

    Time frame: Day30 and Day 60

  3. Safety of CD19 CAR T cells

    Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.

    Time frame: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly

  4. Safety of CD19 CAR T cells

    Number of Participants with Treatment Related immune effector cell-associated neurotoxicity syndrome (ICANS). will be graded according to ASTCT criteria.

    Time frame: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly]

  5. safety of CD19 CAR T cells

    Number of Participants with Treatment-Related cytokine release syndrome (CRS)

    Time frame: Day 1- 8, Day 14-21, Day30, Day60, Day90, Day120, Day180, Day270, and yearly

  6. To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells

    To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using area under the curve (AUC)

    Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month

  7. To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells

    To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using maximum concentration (Cmax)

    Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month

  8. To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells

    To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using minimum concentration (Cmin)

    Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month

  9. To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells

    To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using clearance (Cl)

    Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month

  10. To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells

    To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using volume (V)

    Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month

  11. To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells

    To characterize the pharmacokinetic (PK) profile of CD19 CAR T cells using half-life (T1/2)

    Time frame: Day7, Day14, Day28, 2month, 4 month, 6month,10month,12month 14month,16month,18month,20month, 22month, and 24month

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — yes with Miltenyi our collaborator

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2025 (actual). Primary completion is estimated for Jul 2027, 24 months after the start.

Of 158 non-industry phase 1 interventional studies under Precursor Cell Lymphoblastic Leukemia-Lymphoma, half reached primary completion within 57 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 92. This study's planned 24 months is below that.

Counting every sponsor, half of 208 studies reached it within 55 months; a quarter within 34 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2025
First posted
Jan 22, 2026
StartActual
Jul 29, 2025
Primary completionEst.
Jul 2027
CompletionEst.
Jul 2028
Last update
Jan 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07361029
Lead sponsor
King Faisal Specialist Hospital & Research Center
Collaborators
Miltenyi Biomedicine GmbH
Responsible party
Riad El Fakih (Consultant, Lymphoma / Myeloma, King Faisal Specialist Hospital & Research Center) — Principal investigator
First posted
Jan 22, 2026
Start date
Jul 29, 2025
Primary completion
Jul 2027 (estimated)
Completion
Jul 2028 (estimated)
Last update
Jan 22, 2026

Study contacts

Riad El Fakih
Contact
relfakih1@kfshrc.edu.sa
00966539056287

Oversight

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

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