Adults 1 to 30, any sex, with ALL or B Cell Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Received Preparative Chemotherapy Followed by Cluster of Differentiation (CD)19-Chimeric Antigen Receptor (CAR): CD19 CAR T-cells With < Grade 4 Cytokine Release SyndromePrimary· Beginning of preparative regimen through Day 28 after CD19 CAR infusion
Participants with B cell malignancies who received preparative chemotherapy followed by CD19 CAR T-cells with \< Grade 4 cytokine release syndrome.
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
14
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
4
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
14
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
15
Number of Participants in Which the Prescribed Dose of Cluster of Differentiation (CD)19-Chimeric Antigen Receptor (CAR): CD19 CAR T-cells Were Successfully ManufacturedPrimary· Apheresis through completion of CAR manufacturing process, approximately 2 weeks
Participants who had T-cells collected by apheresis and subsequently had the amount of CAR T-cells manufactured as prescribed by the dose level they were enrolled in.
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
15
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
4
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0
Number of Participants Who Were Administered Intensive Chemotherapy Prior to Cluster of Differentiation (CD)19-Chimeric Antigen Receptor (CAR): CD19 CAR InfusionSecondary· 21 days of target date
Participants who were administered intensive chemotherapy prior to Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR): CD19 CAR infusion and received CAR cells within 21 days of the planned infusion date.
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
0
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
16
Mean Percentage Cluster of Differentiation 19 (CD19) - Chimeric Antigen-Receptor (CAR) T-Cells in Blood, Bone Marrow (BM) and Cerebrospinal Fluid (CSF)Secondary· 28 days (+/- 4 days) after infusion of CD19 CAR T-cells
Measure persistence of adoptively-transferred anti-CD19-CAR transduced T cells (defined by percent of CD19 CAR T-cells) in the blood and where possible the bone marrow and Cerebrospinal Fluid (CSF) of patients by flow cytometry assay.
Peripheral blood
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0.279
± 0.712
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
0.122
± 0.239
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0.343
± 1.022
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0.897
± 1.871
Bone marrow
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0.459
± 0.781
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
0.554
± 0.979
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0.552
± 1.308
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
0.814
± 1.775
Cerebrospinal fluid
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
3.186
± 5.304
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
1.825
± 2.943
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
7.192
± 16.728
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
14.742
± 16.301
Number of Patients With a Complete Response (CR)Secondary· Day 28 (+/- 4 days) after CD19 CAR infusion
Complete Response (CR) was assessed by bone marrow evaluation was I defined as \<5% leukemic blasts.
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
10
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
4
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
11
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
6
Number of Participants With Grade 4 Cytokine Release Syndrome (CRS)Secondary· Day 28 (+/- 4 days) after CD19 CAR infusion.
Participants with Grade 4 Cytokine Release Syndrome (CRS). CRS is defined as a clinical syndrome that may occur after cell therapy due to the release of cytokines (substances secreted by immune cells) into the body's blood stream.
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
2
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
1
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
1
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
1
Number of Participants With Serious and Non-Serious Adverse EventsSecondary· Date treatment consent signed to date off study, from 1.5 months up to 3.1 years.
Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Group
Value
95% CI
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
16
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
5
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
16
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
16
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, from 1.5 months up to 3.1 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase 1, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
Serious: 6/16 (38%)
Deaths: 10/16
Phase 1, Arm 2 - 3 x 10E6 Transduced T Cells/kg (+/- 20%)
Serious: 2/5 (40%)
Deaths: 3/5
Phase 2, Arm 1 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
Serious: 1/16 (6%)
Deaths: 5/16
Phase 2, Arm 2 - 1 x 10E6 Transduced T Cells/kg (+/- 20%)
Background:
\- Although progress has been made in treating children with B-cell cancers such as leukemia or lymphoma, many children do not respond to the standard treatments. One possible treatment involves collecting white blood cells called T cells from the person with cancer and modifying the cells to attack the B-cell cancer. The cells can then be given back to the participant. This study will use T cells that have been modified to attack the cluster of differentiation 19 (CD19) protein, which is found on the surface of some B-cell cancers.
Objectives:
\- To see if anti-CD19 modified white blood cells are a safe and effective treatment for children and young adults with advanced B-cell cancer.
Eligibility:
* Children and young adults between 1 and 30 years of age who have B-cell cancer (leukemia or lymphoma) that has not responded to standard treatments.
* The leukemia or the lymphoma must have the CD19 protein.
* There must be adequate organ function.
Design:
* Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Imaging studies or bone marrow biopsies may be performed depending on the type of cancer.
* Participants will undergo a process where white blood cells are collected, called apheresis. These cells will be modified to contain the anti-CD19 gene.
* Participants will have 3 days of chemotherapy to prepare their immune system to accept the modified cells.
* Participants will receive an infusion of their own modified white blood cells. They will remain in the hospital until they have recovered from the treatment.
* Participants will have frequent follow-up visits to monitor the outcome of the treatment.
* If the participant benefits from the treatment, then he/she may have the option for another round of treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· recruiting
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· recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 31 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01593696.