Acute Lymphoblastic LeukemiaPhase 2NCT06847269
CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia
A Phase 2 study testing Fludarabine, Cyclophosphamide and Mesna in people with Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Refractory Acute Lymphoblastic Leukemia
- What is being tested?
- Fludarabine, Cyclophosphamide and Mesna
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2025to Apr 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- CD19+ leukemia** with any of the following:
- Refractory disease (primary or in relapse)
- 2nd or greater relapse
- Any relapse after allogeneic hematopoietic cell transplantation
- 1st relapse if patient requires an allogeneic HCT as part of standard of care relapse therapy, but is found to be ineligible and/or unsuitable for HCT
- must be confirmed to be CD19+ within 3 months prior to enrollment for treatment
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- Age: ≤ 21 years of age
- Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
- Estimated life expectancy of > 12 weeks. Patients with a history of prior allogeneic hematopoietic cell transplantation [HCT] must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis
- For females of child bearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
- Age: ≤ 21 years of age
- Estimated life expectancy of > 8 weeks
- Detectable disease
- Prior to planned CAR T cell infusion, patients with a history of prior allogeneic HCT must:
- be at least 3 months from HCT
- have no evidence of active GVHD
- have not received a donor lymphocyte infusion (DLI) within the 28 days prior to planned infusion
- Adequate cardiac function defined as left ventricular ejection fraction > 40%, or shortening fraction ≥ 25%
- EKG without evidence of clinically significant arrhythmia
- Adequate renal function defined as creatinine clearance or radioisotope GFR ³ 50 ml/min/1.73m2 (GFR ³ 40 ml/min/1.73m2 if < 2 years of age)
- Adequate pulmonary function defined as forced vital capacity (FVC) ≥ 50% of predicted value; or pulse oximetry ≥ 92% on room air if patient is unable to perform pulmonary function testing
- Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
- Total Bilirubin ≤ 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal for age
- Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
- For patients of child bearing age:
- Not lactating with intent to breastfeed
- Not pregnant with negative serum pregnancy test within 7 days prior to enrollment
- If sexually active, agreement to use birth control until 6 months after T cell infusion.
Who cannot join
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen
- Treatment
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- Active CNS-3 disease
- Known primary immunodeficiency
- History of HIV infection
- Evidence of active, uncontrolled neurologic disease
- Severe, uncontrolled bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Aimee Talleur, MD, 866-278-5833, referralinfo@stjude.org
Aimee Talleur, MD
About this study
Official title: CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility.
The main purpose of this study is to determine:
- Evaluate different doses of fludarabine prior CAR T cell infusion
- How your body processes fludarabine and cyclophosphamide,
- How long the CAR T cells last in the body,
- Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and
- The side effects of this therapy.
Read the detailed description
CAR19PK is a Phase II study evaluating lymphodepleting chemotherapy (age-based fludarabine dosing and cyclophosphamide), followed by infusion of CD19-CAR T cells, in pediatric and young adult patients ≤ 21 years old with relapsed/refractory CD19-positive leukemia. Treatment will include a single course of lymphodepleting chemotherapy followed by CAR T cell infusion. Lymphodepletion will include fludarabine (dosing based on age) and cyclophosphamide. The CAR T cell infusion will include a single infusion of 3x10^6 CD19-CAR T cells/kg patient weight.
This protocol contains a two-part consent process: 1) to proceed with autologous apheresis and 2) to proceed with treatment with lymphodepleting chemotherapy and infusion of the CD19-CAR T cell product.
- Being tested
- Fludarabine, Cyclophosphamide, Mesna, CD19-CAR T cell Infusion
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FludarabineDrug
Given IV
CyclophosphamideDrug
Given IV
MesnaDrug
Given IV
CD19-CAR T cell InfusionBiological
Patients will receive the CD19-CAR T cells by vein, through either an IV or a central line.
| Study group | Role | What they receive |
|---|---|---|
| CAR19PK Therapy | Experimental | This study contains two phases.
Collection and Manufacturing Phase:
Patient blood cells will be collected, and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells.
Treatment Phase:
Patients that meet eligibility for treatment will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by an infusion of CD19-CAR T cells that were made in the Collection and Manufacturing Phase. Receives: Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Mesna; Biological: CD19-CAR T cell Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fludarabine Pharmacokinetics
Determination of Fludarabine exposure (area under the curve [AUC], mg-hr/L) using blood samples collected on days -5, -4 and -3
Measured: Days -5, -4 and -3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start21 May 2025
- Primary completionMar 2030 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aimee Talleur, MD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06847269
- Sponsor's protocol ID
- CAR19PK
- Status last verified
- Mar 2026
- First submitted
- 21 Feb 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR T CELL Therapy for Pediatric, Adolescent and Young Adult Patients With CD19-Positive Leukemia: An Investigation of Lymphodepleting Chemotherapy Pharmacokinetics
- ClinicalTrials.gov ID
- NCT06847269
- Acronym / sponsor ID
- CAR19PK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 26 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
CAR19PK is a research study evaluating the use of lymphodepleting chemotherapy and chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy, for the treatment of refractory and/or relapsed leukemia. For this type of therapy, peripheral (circulating) immune cells are collected and then modified so that they can recognize an antigen, which is a particle present on the surface of a cancer cell. The CD19-CAR T cell product will be manufactured at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility.
The main purpose of this study is to determine:
- Evaluate different doses of fludarabine prior CAR T cell infusion
- How your body processes fludarabine and cyclophosphamide,
- How long the CAR T cells last in the body,
- Whether or not treatment with this therapy is effective in treating people with refractory or relapsed leukemia, and
- The side effects of this therapy.
Detailed description
CAR19PK is a Phase II study evaluating lymphodepleting chemotherapy (age-based fludarabine dosing and cyclophosphamide), followed by infusion of CD19-CAR T cells, in pediatric and young adult patients ≤ 21 years old with relapsed/refractory CD19-positive leukemia. Treatment will include a single course of lymphodepleting chemotherapy followed by CAR T cell infusion. Lymphodepletion will include fludarabine (dosing based on age) and cyclophosphamide. The CAR T cell infusion will include a single infusion of 3x10^6 CD19-CAR T cells/kg patient weight.
This protocol contains a two-part consent process: 1) to proceed with autologous apheresis and 2) to proceed with treatment with lymphodepleting chemotherapy and infusion of the CD19-CAR T cell product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR19PK Therapy | Experimental | Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Mesna, Biological: CD19-CAR T cell InfusionThis study contains two phases. Collection and Manufacturing Phase: Patient blood cells will be collected, and possibly frozen, via a process called apheresis. These cells will then be changed to improve their ability to recognize and kill cancer cells. Treatment Phase: Patients that meet eligibility for treatment will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by an infusion of CD19-CAR T cells that were made in the Collection and Manufacturing Phase. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (31 listed)
- CD19+ leukemia** with any of the following:
- Age: ≤ 21 years of age
- Karnofsky or Lansky (age-dependent) performance score ≥ 50 (Appendix A)
- Estimated life expectancy of > 12 weeks. Patients with a history of prior allogeneic hematopoietic cell transplantation [HCT] must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis
- For females of child bearing age:
Key exclusion criteria (13 listed)
- Known primary immunodeficiency
- History of HIV infection
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity reactions to murine protein-containing products
- Known contraindication to receiving protocol defined lymphodepleting chemotherapy regimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FludarabineGiven IV | Drug | CAR19PK Therapy |
| CyclophosphamideGiven IV | Drug | CAR19PK Therapy |
| MesnaGiven IV | Drug | CAR19PK Therapy |
| CD19-CAR T cell InfusionPatients will receive the CD19-CAR T cells by vein, through either an IV or a central line. | Biological | CAR19PK Therapy |
Primary outcome
Fludarabine Pharmacokinetics
Time frame: Days -5, -4 and -3
Determination of Fludarabine exposure (area under the curve [AUC], mg-hr/L) using blood samples collected on days -5, -4 and -3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aimee Talleur, MD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fludarabine, Cyclophosphamide and Mesna in people with Acute Lymphoblastic Leukemia and Refractory Acute Lymphoblastic Leukemia, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 31 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimee Talleur, MD (8662785833, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fludarabine Pharmacokinetics (time frame: Days -5, -4 and -3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.