Trial · NCT03448393
CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
NCT03448393, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2025-06-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies. Trials, record NCT03448393. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03448393
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CD19/CD22 Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory CD19/CD22-expressing B Cell Malignancies
- NCT number
- NCT03448393
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 54 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Lymphoma, Non-Hodgkin, Leukemia, Lymphocytic, B Cell, B-Cell Lymphoma, B-Cell Leukemia, Acute Lymphoid Leukemia, B-Non Hodgkin Lymphoma, B-NHL, B-All, Acute Lymphoblastic Leukemia, Acute Lymphocytic Leukemia
- Interventions
- CD19/CD22 CAR T-Cells, Fludarabine, Cyclophosphamide, Apheresis, Anti-emetic, Diphenhydramine, Acetaminophen, ECG, ECHO, MRI Brain, Bone marrow biopsy, Cardiac MRI
- First posted
- 2018-02-28
- Last updated
- 2025-06-04
- Results first posted
- 2025-06-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Grades of Toxicity by Type of Toxicity | From start of lymphodepleting chemotherapy regimen through 30-days after chimeric antigen receptor (CAR) infusion (approximately 5 weeks). | Safety analyses will consist of tabulations of grades of toxicity by type of toxicity assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening, and Grade 5 is death related to adverse event. |
| Primary | Maximum Tolerated Dose (MTD) | First 28 days after cell infusion | MTD is defined as the dose level immediately below the level at which the enrollment is stopped due to dose-limiting toxicity (DLT). A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion. |
| Secondary | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | CAR infusion (Day 0) | Number of participants that have the targeted dose number of CAR cells successfully manufactured (i.e., number of participants enrolled where the correct number of cells are produces at the dose level that are enrolled) as measured by total number of viable cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) transduced T cells. |
| Secondary | Overall Survival | Number of months from CAR cell infusion until date of death or time of censor (max 66.6 months) | Overall survival (OS) will be determined as the time from the date of chimeric antigen receptor (CAR) infusion until death. |
| Secondary | Progression-free Survival (PFS) | Number of months from CAR cell infusion until time of disease progression, death, or date of censor (up to 67 months) | PFS is assessed from the date of chimeric antigen receptor (CAR) infusion until the documentation of disease progression or death due to any cause, whichever occurs first. Disease progression was assessed by the Response Criteria Lymphoma and is defined as individual node/lesion must be abnormal with LDI\>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in longest transverse diameter of a lesion (LDI) or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm, 1.0 cm for lesions \> 2 cm; and the International Working Group and is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts. |
| Secondary | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | At Day 28 (+/- 4 days) after CAR cell infusion | Clinical activity (response) in children (age ≥3 years to 17 years) and young adults (age 18 years to ≤ 39 years) was measured by the Response Criteria Lymphoma. Complete Response (CR) is complete metabolic and/or radiographic response. Partial Response (PR) is partial metabolic response or partial remission. Stable Disease (SD) is no metabolic response or 50% decrease from baseline in the sum of products of diameters (SPD) of up to 6 dominant measurable nodes and extra nodal sites. Progressive Disease (PD) is individual node/lesion must be abnormal with longest transverse diameter of a lesion (LDI) \>1.5 cm and increase by ≥50% from product of perpendicular diameters (PPD) nadir and an increase in LDI or shortest axis perpendicular to LDi (SDI) from nadir 0.5 cm for lesions ≤2 cm and/or 1.0 cm for lesions \> 2 cm; also assessed by the International Working Group and PD is defined as worse marrow classification with at least a 50% increase in the percentage of marrow blasts. |
| Other | Number of Participants With a Dose-limiting Toxicity (DLT) | First 28 days | A DLT is defined as an adverse event that is at least possibly related to the cluster of differentiation 19/cluster of differentiation 22 (CD19/CD22)-chimeric antigen receptor (CAR) T cells with onset within the first 28 days after cell infusion. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Adverse Events were monitored/assessed from the first study intervention, Study Day -4, through day 30 after the study agent (s) was/were administered, an average of 5 weeks. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). 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 of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Grades of Toxicity by Type of Toxicity | From start of lymphodepleting chemotherapy regimen through 30-days after chimeric antigen receptor (CAR) infusion (approximately 5 weeks). | 16/54 participants were not treated including 15 participants that were screen failures. Only grade 3, 4, and 5 toxicities at least possibly related to either research and/or investigational new drug application (IND) will be reported. | toxicities | NUMBER |
| PRIMARY | Maximum Tolerated Dose (MTD) | First 28 days after cell infusion | 16/54 participants were not treated. Only participants in the dose escalation phase of the study are included in this analysis (Groups 1-5). | 10^6 CAR T cells/kg | NUMBER |
| SECONDARY | Number of Participants That Have Successful Manufacture of the Targeted Dose Number of Chimeric Antigen Receptor (CAR) Cells | CAR infusion (Day 0) | 16/54 participants were not treated. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | Number of months from CAR cell infusion until date of death or time of censor (max 66.6 months) | 16/54 participants were not treated. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | Number of months from CAR cell infusion until time of disease progression, death, or date of censor (up to 67 months) | 16/54 participants were not treated. | Months | MEDIAN |
| SECONDARY | Clinical Activity (Response) in Children and Young Adults With B-cell Acute Lymphoblastic Leukemia (B-ALL), Isolated Central Nervous System (CNS) ALL, or Lymphoma Who Previously Received Chimeric Antigen Receptor (CAR) Therapy and Those That Are CAR Naive | At Day 28 (+/- 4 days) after CAR cell infusion | 16/54 participants were not treated. Participants treated in Group 1-3 will be excluded from this outcome measure as assignment to CAR naïve versus CAR pre-treated did not occur in the beginning of the trial. The study was not looking at response in children vs young adults separately. It was looking at response in children and young adults only (no adults over 39). Also, it is not powered to look at children and young adults separately. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose-limiting Toxicity (DLT) | First 28 days | 16/54 participants were not treated. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). | Adverse Events were monitored/assessed from the first study intervention, Study Day -4, through day 30 after the study agent (s) was/were administered, an average of 5 weeks. | 16/54 participants were not treated. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group381
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Grades of Toxicity by Type of Toxicity | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grade 3 Anemia | 2 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grade 3 Anemia | 2 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grade 3 Anemia | 1 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grade 3 Anemia | 1 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grade 3 Anemia | 1 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | Grade 3 Anemia | 13 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | Grade 3 Anemia | 1 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | Grade 3 Anemia | 0 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | Grade 3 Febrile neutropenia | 1 | toxicities | |
| Grades of Toxicity by Type of Toxicity | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | Grade 3 Febrile neutropenia | 2 | toxicities |
1 to 10 of 381Source ClinicalTrials.gov
See all 381 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation | STARTED | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 4 | |
| Dose Escalation | STARTED | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | 4 | |
| Dose Escalation | STARTED | GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 5 | |
| Dose Escalation | STARTED | GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 2 | |
| Dose Escalation | STARTED | GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 1 | |
| Dose Escalation | STARTED | GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 0 | |
| Dose Escalation | STARTED | GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | 0 | |
| Dose Escalation | STARTED | GROUP 8: Cohort 2C, Dose Level 3, 3 x 10^6 Transduced T-cells/kg (+Or- 20%) | 0 | |
| Dose Escalation | STARTED | Enrolled and Not Assigned to a Treatment Assignment Code; Not Treated | 8 | |
| Dose Escalation | COMPLETED | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 4 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events1,656
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 0 | 4 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | 0 | 4 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 0 | 4 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 0 | 2 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 0 | 1 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 4 | 21 | 5 |
| other | Abdominal distension | Gastrointestinal disorders | GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | 0 | 1 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Group 8:Cohort 2C, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation | 0 | 1 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 2 | 4 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | 2 | 4 | 3 |
1 to 10 of 1,656Source ClinicalTrials.gov
See all 1,656 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 4 | 4 |
| Total, all-cause mortality | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | 3 | 4 |
| Total, all-cause mortality | GROUP 3: Cohort 1, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 2 | 4 |
| Total, all-cause mortality | GROUP 4: Cohort 1A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 2 | 2 |
| Total, all-cause mortality | GROUP 5: Cohort 1B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 0 | 1 |
| Total, all-cause mortality | GROUP 6: Cohort 2A, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20%) | 8 | 21 |
| Total, all-cause mortality | GROUP 7: Cohort 2B, Dose Level 3, 3 x10^6 Transduced T Cells/kg (+Or-20% | 1 | 1 |
| Total, all-cause mortality | Group 8:Cohort 2C, CAR Naïve or CAR Pretreated With Previous Hematopoietic Stem Cell Transplantation | 0 | 1 |
| Total, other adverse events | GROUP 1: Cohort 1, Dose Level 1, 3 x10^5 Transduced T Cells/kg (+Or-20%) | 4 | 4 |
| Total, other adverse events | GROUP 2: Cohort 1, Dose Level 2, 1x10^6 Transduced T Cells/kg (+Or-20%) | 4 | 4 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03448393
GET https://conductscience.org/api/trials/v1/NCT03448393/results?page=2