LeukemiaPhase 1NCT01044069

Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

A Phase 1 study testing gene-modified T cells targeted in people with Leukemia and Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Leukemia, Acute Lymphoblastic Leukemia
What is being tested?: gene-modified T cells targeted
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteUnited States
Study dates: 5 Jan 2010to Jan 2027
Phase: Phase 1
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients are eligible (> or = to 18 year old).
Patients must have B- ALL refractory, relapsed, MRD, or in first CR as described below.
Complete remission is defined as restoration of normal hematopoiesis with a neutrophil count > 1,000 x 106/L, a platelet count > 100,000 x 106/L, and hemoglobin > 10 g/dL. Blasts should be < 5% in a post-treatment bone marrow differential. Furthermore, there should be no clinical evidence of leukemia for a minimum of four weeks.
MRD is defined as patients meeting the criteria for CR above, but with residual disease measured by a quantitative PCR, or by flow or by deep-sequencing of the IgH rearrangements . The assay from blood and/or bone marrow defines MRD by qPCR as a cycle threshold (CT) that is at least 1 CT value < than the lowest CT value from the background. Outside laboratory tests may suffice for this assessment at the discretion of the Principal Investigator.
Relapsed B-ALL will be defined as patients that meet the above criteria for a CR before developing recurrent disease (increased bone marrow blasts). Refractory patients will be defined as patients that have not achieved a CR after 1 cycle of induction chemotherapy
Patients must have a diagnosis of B-ALL by flow cytometry, or bone marrow histology, and/or cytogenetics.

Show all 12Show fewer

Patients must have CD19+ ALL as confirmed by flow cytometry and/or immunohistochemistry.
Creatinine < 2.0 mg/100 ml, bilirubin < 2.0 mg/100 ml, AST and ALT < 3x normal, PT and PTT < 2x normal outside the setting of stable chronic anticoagulation therapy. LFTs (Bilirubin, AST, and/or ALT) may be acceptable if the elevation is secondary to leukemia infiltration or leukemia therapy with tyrosine kinase inhibitors.
Adequate cardiac function (LVEF ≥ 40%) as assessed by ECHO or MUGA or other similar cardiac imaging performed within 1 month of enrollment.
Adequate pulmonary function as assessed by ≥ 92% oxygen saturation on room air by pulse oximetry.
Patients must have adequate access for leukapheresis procedure as assessed by staff from the MSKCC Donor Room.
Life expectancy > 3 months

Who cannot join

Karnofsky performance status < 70.
Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurologic dysfunction) within 28 days of enrollment. Prophylactic intrathecal medication is not a reason for exclusion.
Patients previously treated with an allogeneic SCT that is currently complicated by active GVHD requiring T cell suppressive therapy.
Patients with following cardiac conditions will be excluded:
New York Heart Association (NYHA) stage III or IV congestive heart failure
Myocardial infarction ≤6 months prior to enrollment

Show all 10Show fewer

History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
History of severe non-ischemic cardiomyopathy with EF ≤20%
Patients with HIV, hepatitis B or hepatitis C infection.
Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Memorial Sloan Kettering Cancer Center
New York, New York, 10065

Other trials in United States

About this study

Official title: A Phase I Trial of Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19

This study is an investigational approach that uses immune cells, called "T cells", to kill leukemia. These T cells are removed from blood, modified in a laboratory, and then put back in the body. T cells fight infections and can also kill cancer cells in some cases. However, right now T cells are unable to kill the cancer cells. For this reason we will put one gene into the T cells that allows them to recognize and kill the leukemia cells. This gene will be put in the T cells by a weakened virus. The gene will produce proteins in the T cells that help the T cells recognize the leukemia cells and possibly kill them. The doctors have found that T cells modified in this way can cure an ALL-like cancer in mice.

The main goals of this study is to determine the safety and appropriate dose of these modified T cells in patients with ALL. This will be done in a "clinical trial." The dose of modified T-cells will depend on if you have disease present in your bone marrow or not. The patient will also receive chemotherapy before the T cells. We will use normally chemotherapy that is used in patients with leukemia. The chemotherapy is given to reduce leukemia and to allow the T cells to live longer.

Conditions: Leukemia, Acute Lymphoblastic Leukemia
Being tested: gene-modified T cells targeted
Keywords: Cyclophosphamide, T cell, leukapheresis, stem cell transplant, bone marrow transplant, 09-114
Medical subject headings: Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

gene-modified T cells targetedBiological
Pts will undergo leukapheresis. The leukapheresis product will be washed \& frozen until the GTF is directed to start T cell production by the PI. CD3+ T cells will be isolated from the leukapheresis, \& transduced with the 19-28z chimeric receptor \& expanded. All relapsed (either MRD+ or morphologic) \& refractory pts get re-induction chemo whenever feasible to optimally reduce the tumor burden prior to the T cell infusion. The re-induction chemo regimen will be selected by the treating dr. based on prior therapy, adverse reactions to chemo \& highest likelihood to achieve an optimal response. Once pts recover from the toxicities of the re-induction chemo the disease status will be re-evaluated by repeating bone marrow aspirate or biopsy. Pts get conditioning chemo (min 2 weeks from end of re-induction chemo) followed 2-7 days later by the 19-28z+ T cells. Pts will be tx in 2 cohorts with diff doses of T cells according to the amount of disease immediately prior to the T cell infusion.

Study groups in NCT01044069
Study group	Role	What they receive
Pts with B Cell Acute Lymphoblastic Leukemia	Experimental	This is a phase I study. Patients with CD19+ ALL (CR, relapsed, MRD, or refractory) are eligible for enrollment. B-ALL patients in first CR will be enrolled but only treated if they develop MRD or a frank relapse, while patients with MRD or with documented relapsed/refractory disease are eligible for immediate treatment. The T cell doses originally proposed in this study were based on doses administered safely in prior autologous T cell adoptive therapy trials but the dose has been modified based on the toxicities observed in patients with morphologic evidence of disease. Patients will be treated with different doses of T cells depending on the amount of disease at the time of T cell infusion. Patients in Cohort 1 (<5% blasts in the BM) will continue to receive 10^6 19-28z+ T cells/kg as previously. Patients in Cohort 2 (≥5% blasts in the BM) will receive the reduced dose of 1x106 19-28z+ T cells/kg). Receives: Biological: gene-modified T cells targeted

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL.
Measured: 2 years

Secondary outcomes (1)

To assess the anti-leukemic effect of adoptively transferred anti-CD19 T cells.
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jan 2010Jan 2027

First posted7 Jan 2010 (estimated)
Study start5 Jan 2010
Primary completionJan 2027 (estimated)
Study completionJan 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for LeukemiaStudies of the same condition, open and under way.
More trials run by Memorial Sloan Kettering Cancer CenterThe 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 93 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01044069
Sponsor's protocol ID: 09-114
Status last verified: Sep 2026
First submitted: 6 Jan 2010
Last updated: 8 Sep 2026
Results posted: No
Data monitoring committee: Yes

Publications

Krawczyk M, Druzynska M, Bednarska E, Winiarska M. The race between 4-1BB- and CD28-based CD19 CAR-T products in the therapy of B-cell malignancies. Biochim Biophys Acta Rev Cancer. 2026 Feb;1881(1):189519. doi: 10.1016/j.bbcan.2025.189519. Epub 2025 Dec 20.
PubMed 41429239
Valtis YK, Lin C, Nemirovsky D, Devlin S, Rejeski K, Curran KJ, Wang X, Shah NN, Jeyakumar N, Miller K, Zhang A, Kota VK, Al Darobi AH, Muhsen I, Sasine J, Aldoss I, Advani AS, Reshef R, Chen EC, Kopmar N, Tsai SB, Hilal T, Shah BD, Faramand R, Solh MM, Tan V, Bezerra E, Battiwalla M, Ramakrishnan A, Mathews J, Shaughnessy P, Mountjoy L, Hoeg RT, Dykes KC, Logan AC, Kumaran MV, Schwartz M, Tracy S, Moore J, Odstrcil Bobillo S, Frey NV, Connor M, Ladha A, Dholaria B, Sutherland K, Roloff GW, Muffly LS, Park JH. CAR HEMATOTOX independently predicts outcomes after CD19 CAR-T therapy for acute lymphoblastic leukemia. Blood Adv. 2026 Jan 13;10(1):276-288. doi: 10.1182/bloodadvances.2025017526.
PubMed 41052404
Jain T, Knezevic A, Pennisi M, Chen Y, Ruiz JD, Purdon TJ, Devlin SM, Smith M, Shah GL, Halton E, Diamonte C, Scordo M, Sauter CS, Mead E, Santomasso BD, Palomba ML, Batlevi CW, Maloy MA, Giralt S, Smith E, Brentjens R, Park JH, Perales MA, Mailankody S. Hematopoietic recovery in patients receiving chimeric antigen receptor T-cell therapy for hematologic malignancies. Blood Adv. 2020 Aug 11;4(15):3776-3787. doi: 10.1182/bloodadvances.2020002509.
PubMed 32780846
Pennisi M, Jain T, Santomasso BD, Mead E, Wudhikarn K, Silverberg ML, Batlevi Y, Shouval R, Devlin SM, Batlevi C, Brentjens RJ, Dahi PB, Diamonte C, Giralt S, Halton EF, Maloy M, Palomba ML, Sanchez-Escamilla M, Sauter CS, Scordo M, Shah G, Park JH, Perales MA. Comparing CAR T-cell toxicity grading systems: application of the ASTCT grading system and implications for management. Blood Adv. 2020 Feb 25;4(4):676-686. doi: 10.1182/bloodadvances.2019000952.
PubMed 32084260
Park JH, Romero FA, Taur Y, Sadelain M, Brentjens RJ, Hohl TM, Seo SK. Cytokine Release Syndrome Grade as a Predictive Marker for Infections in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia Treated With Chimeric Antigen Receptor T Cells. Clin Infect Dis. 2018 Aug 1;67(4):533-540. doi: 10.1093/cid/ciy152.
PubMed 29481659
Park JH, Riviere I, Gonen M, Wang X, Senechal B, Curran KJ, Sauter C, Wang Y, Santomasso B, Mead E, Roshal M, Maslak P, Davila M, Brentjens RJ, Sadelain M. Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):449-459. doi: 10.1056/NEJMoa1709919.
PubMed 29385376
Brentjens RJ, Riviere I, Park JH, Davila ML, Wang X, Stefanski J, Taylor C, Yeh R, Bartido S, Borquez-Ojeda O, Olszewska M, Bernal Y, Pegram H, Przybylowski M, Hollyman D, Usachenko Y, Pirraglia D, Hosey J, Santos E, Halton E, Maslak P, Scheinberg D, Jurcic J, Heaney M, Heller G, Frattini M, Sadelain M. Safety and persistence of adoptively transferred autologous CD19-targeted T cells in patients with relapsed or chemotherapy refractory B-cell leukemias. Blood. 2011 Nov 3;118(18):4817-28. doi: 10.1182/blood-2011-04-348540. Epub 2011 Aug 17.
PubMed 21849486

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I Trial of Precursor B Cell Acute Lymphoblastic Leukemia (B-ALL) Treated With Autologous T Cells Genetically Targeted to the B Cell Specific Antigen CD19
ClinicalTrials.gov ID: NCT01044069
Acronym / sponsor ID: 09-114
Conditions: Leukemia, Acute Lymphoblastic Leukemia
Keywords: Cyclophosphamide, T cell, leukapheresis, stem cell transplant, bone marrow transplant, 09-114
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 93 participants (estimated)
Lead sponsor: Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
Study start: 5 Jan 2010 (actual)
Primary completion: Jan 2027 (estimated)
Study completion: Jan 2027 (estimated)
First posted: 7 Jan 2010 (estimated)
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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pts with B Cell Acute Lymphoblastic Leukemia	Experimental	Biological: gene-modified T cells targetedThis is a phase I study. Patients with CD19+ ALL (CR, relapsed, MRD, or refractory) are eligible for enrollment. B-ALL patients in first CR will be enrolled but only treated if they develop MRD or a frank relapse, while patients with MRD or with documented relapsed/refractory disease are eligible for immediate treatment. The T cell doses originally proposed in this study were based on doses administered safely in prior autologous T cell adoptive therapy trials but the dose has been modified based on the toxicities observed in patients with morphologic evidence of disease. Patients will be treated with different doses of T cells depending on the amount of disease at the time of T cell infusion. Patients in Cohort 1 (<5% blasts in the BM) will continue to receive 10^6 19-28z+ T cells/kg as previously. Patients in Cohort 2 (≥5% blasts in the BM) will receive the reduced dose of 1x106 19-28z+ T cells/kg).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Adult patients are eligible (> or = to 18 year old).
Patients must have B- ALL refractory, relapsed, MRD, or in first CR as described below.
Complete remission is defined as restoration of normal hematopoiesis with a neutrophil count > 1,000 x 106/L, a platelet count > 100,000 x 106/L, and hemoglobin > 10 g/dL. Blasts should be < 5% in a post-treatment bone marrow differential. Furthermore, there should be no clinical evidence of leukemia for a minimum of four weeks.
MRD is defined as patients meeting the criteria for CR above, but with residual disease measured by a quantitative PCR, or by flow or by deep-sequencing of the IgH rearrangements . The assay from blood and/or bone marrow defines MRD by qPCR as a cycle threshold (CT) that is at least 1 CT value < than the lowest CT value from the background. Outside laboratory tests may suffice for this assessment at the discretion of the Principal Investigator.
Relapsed B-ALL will be defined as patients that meet the above criteria for a CR before developing recurrent disease (increased bone marrow blasts). Refractory patients will be defined as patients that have not achieved a CR after 1 cycle of induction chemotherapy

Key exclusion criteria (10 listed)

Karnofsky performance status < 70.
Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurologic dysfunction) within 28 days of enrollment. Prophylactic intrathecal medication is not a reason for exclusion.
Patients previously treated with an allogeneic SCT that is currently complicated by active GVHD requiring T cell suppressive therapy.
New York Heart Association (NYHA) stage III or IV congestive heart failure
Myocardial infarction ≤6 months prior to enrollment

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
gene-modified T cells targetedPts will undergo leukapheresis. The leukapheresis product will be washed \& frozen until the GTF is directed to start T cell production by the PI. CD3+ T cells will be isolated from the leukapheresis, \& transduced with the 19-28z chimeric receptor \& expanded. All relapsed (either MRD+ or morphologic) \& refractory pts get re-induction chemo whenever feasible to optimally reduce the tumor burden prior to the T cell infusion. The re-induction chemo regimen will be selected by the treating dr. based on prior therapy, adverse reactions to chemo \& highest likelihood to achieve an optimal response. Once pts recover from the toxicities of the re-induction chemo the disease status will be re-evaluated by repeating bone marrow aspirate or biopsy. Pts get conditioning chemo (min 2 weeks from end of re-induction chemo) followed 2-7 days later by the 19-28z+ T cells. Pts will be tx in 2 cohorts with diff doses of T cells according to the amount of disease immediately prior to the T cell infusion.	Biological	Pts with B Cell Acute Lymphoblastic Leukemia

Primary outcome

To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL.
Time frame: 2 years

1 secondary outcome

To assess the anti-leukemic effect of adoptively transferred anti-CD19 T cells.
Time frame: 2 years

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 8 Sep 2026.
Derived from this study: PubMed 41429239Krawczyk M, Druzynska M, Bednarska E, Winiarska M. The race between 4-1BB- and CD28-based CD19 CAR-T products in the therapy of B-cell malignancies. Biochim Biophys Acta Rev Cancer. 2026 Feb;1881(1):189519. doi: 10.1016/j.bbcan.2025.189519. Epub 2025 Dec 20.
Derived from this study: PubMed 41052404Valtis YK, Lin C, Nemirovsky D, Devlin S, Rejeski K, Curran KJ, Wang X, Shah NN, Jeyakumar N, Miller K, Zhang A, Kota VK, Al Darobi AH, Muhsen I, Sasine J, Aldoss I, Advani AS, Reshef R, Chen EC, Kopmar N, Tsai SB, Hilal T, Shah BD, Faramand R, Solh MM, Tan V, Bezerra E, Battiwalla M, Ramakrishnan A, Mathews J, Shaughnessy P, Mountjoy L, Hoeg RT, Dykes KC, Logan AC, Kumaran MV, Schwartz M, Tracy S, Moore J, Odstrcil Bobillo S, Frey NV, Connor M, Ladha A, Dholaria B, Sutherland K, Roloff GW, Muffly LS, Park JH. CAR HEMATOTOX independently predicts outcomes after CD19 CAR-T therapy for acute lymphoblastic leukemia. Blood Adv. 2026 Jan 13;10(1):276-288. doi: 10.1182/bloodadvances.2025017526.
Derived from this study: PubMed 32780846Jain T, Knezevic A, Pennisi M, Chen Y, Ruiz JD, Purdon TJ, Devlin SM, Smith M, Shah GL, Halton E, Diamonte C, Scordo M, Sauter CS, Mead E, Santomasso BD, Palomba ML, Batlevi CW, Maloy MA, Giralt S, Smith E, Brentjens R, Park JH, Perales MA, Mailankody S. Hematopoietic recovery in patients receiving chimeric antigen receptor T-cell therapy for hematologic malignancies. Blood Adv. 2020 Aug 11;4(15):3776-3787. doi: 10.1182/bloodadvances.2020002509.
Derived from this study: PubMed 32084260Pennisi M, Jain T, Santomasso BD, Mead E, Wudhikarn K, Silverberg ML, Batlevi Y, Shouval R, Devlin SM, Batlevi C, Brentjens RJ, Dahi PB, Diamonte C, Giralt S, Halton EF, Maloy M, Palomba ML, Sanchez-Escamilla M, Sauter CS, Scordo M, Shah G, Park JH, Perales MA. Comparing CAR T-cell toxicity grading systems: application of the ASTCT grading system and implications for management. Blood Adv. 2020 Feb 25;4(4):676-686. doi: 10.1182/bloodadvances.2019000952.
Derived from this study: PubMed 29481659Park JH, Romero FA, Taur Y, Sadelain M, Brentjens RJ, Hohl TM, Seo SK. Cytokine Release Syndrome Grade as a Predictive Marker for Infections in Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia Treated With Chimeric Antigen Receptor T Cells. Clin Infect Dis. 2018 Aug 1;67(4):533-540. doi: 10.1093/cid/ciy152.
Derived from this study: PubMed 29385376Park JH, Riviere I, Gonen M, Wang X, Senechal B, Curran KJ, Sauter C, Wang Y, Santomasso B, Mead E, Roshal M, Maslak P, Davila M, Brentjens RJ, Sadelain M. Long-Term Follow-up of CD19 CAR Therapy in Acute Lymphoblastic Leukemia. N Engl J Med. 2018 Feb 1;378(5):449-459. doi: 10.1056/NEJMoa1709919.
Derived from this study: PubMed 21849486Brentjens RJ, Riviere I, Park JH, Davila ML, Wang X, Stefanski J, Taylor C, Yeh R, Bartido S, Borquez-Ojeda O, Olszewska M, Bernal Y, Pegram H, Przybylowski M, Hollyman D, Usachenko Y, Pirraglia D, Hosey J, Santos E, Halton E, Maslak P, Scheinberg D, Jurcic J, Heaney M, Heller G, Frattini M, Sadelain M. Safety and persistence of adoptively transferred autologous CD19-targeted T cells in patients with relapsed or chemotherapy refractory B-cell leukemias. Blood. 2011 Nov 3;118(18):4817-28. doi: 10.1182/blood-2011-04-348540. Epub 2011 Aug 17.
Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.

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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. This study is not recruiting at the moment.

Jae Park, MD principal investigator

Memorial Sloan Kettering Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing gene-modified T cells targeted in people with Leukemia and Acute Lymphoblastic Leukemia, run by Memorial Sloan Kettering Cancer Center 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 12 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety of adoptive transfer of gene-modified autologous CD19-specific T cells in adult patients with B-ALL. (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01044069, which also lists 7 linked publications.

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 8 Sep 2026.