Trial · NCT05418088
Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
NCT05418088, Phase 1, Recruiting, Sumithira Vasu
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies. Trials, record NCT05418088. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05418088
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Genetically Engineered Cells (Anti-CD19/CD20/CD22 CAR T-cells) for the Treatment of Relapsed or Refractory Lymphoid Malignancies
- NCT number
- NCT05418088
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 54 participants, estimated
- Lead sponsor
- Sumithira Vasu
- Conditions
Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia, Recurrent B-Cell Prolymphocytic Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent High Grade B-Cell Lymphoma, Recurrent Indolent Non-Hodgkin Lymphoma, Recurrent Non-Hodgkin Lymphoma, Recurrent Transformed Chronic Lymphocytic Leukemia, Refractory Acute Lymphoblastic Leukemia, Refractory B Acute Lymphoblastic Leukemia, Refractory B-Cell Prolymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory High Grade B-Cell Lymphoma, Refractory Indolent Non-Hodgkin Lymphoma, Refractory Non-Hodgkin Lymphoma, Refractory Transformed Chronic Lymphocytic Leukemia, Refactory Childhood Acute Lymphoblastic Leukemia, Refractory Childhood Non-Hodgkin Lymphoma
- Interventions
- Anti-CD19/CD20/CD22 CAR T-Cells, Cyclophosphamide, Fludarabine Phosphate, Echocardiography, Multigated Acquisition Scan, Biopsy, Pheresis, Bone Marrow Aspiration and Biopsy, Biospecimen Collection
- First posted
- 2022-06-14
- Last updated
- 2026-05-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Recommended phase II dose of anti-CD19/CD20/CD22 CAR-T cells for each study group (Cohort A, Cohort B, and Cohort C) | Up to 30 days after CAR T-cell infusion | |
| Secondary | Incidence of adverse events | Up to 12 months after completion of study treatment | Will be evaluated with descriptive statistics for the frequencies of adverse events of different grades. |
| Secondary | Overall response rate | Up to 15 years | Will be evaluated with descriptive statistics with proportions used to describe response rates. |
| Secondary | Complete response rate | Up to 15 years | Will be evaluated with descriptive statistics with proportions used to describe response rates. |
| Secondary | Overall survival | Up to 15 years | Will be calculated using Kaplan Meier method, comparisons between groups will be done using the log rank test. |
| Secondary | Progression-free survival | From entry onto study until lymphoma progression or death from any cause, assessed up to 15 years | Will be calculated using Kaplan Meier method, comparisons between groups will be done using the log rank test. |
| Other | Correlation between cytokine serum concentrations and disease response | Up to 15 years | Will be analyzed with descriptive statistics, including evaluations of median, minimum and peak values. Area under the curve (AUC) will be used as a measure of cytokine secretion. Comparisons will be done between responding and non-responding patients using the Mann - Whitney test for quantitative variables and Fisher's exact test for categorical variables. The Wilcoxon test will be used to evaluate the changes in cytokine concentrations. Correlations between quantitative variables will be done with Spearman's correlation test, whereas correlation between categorical variables will be done using Fisher's exact test. |
| Other | Presence of measurable CAR-T cells | Up to 12 months | Will be analyzed with descriptive statistics, including evaluations of median, minimum and peak values. Area under the curve (AUC) will be used as a measure of CAR-T cell expansion and persistence. Comparisons will be done between responding and non-responding patients using the Mann - Whitney test for quantitative variables and Fisher's exact test for categorical variables. The Wilcoxon test will be used to evaluate CAR-T cell expansion and changes in T cell phenotype over time. Correlations between quantitative variables will be done with Spearman's correlation test, whereas correlation between categorical variables will be done using Fisher's exact test. |
| Other | Correlation between CD19/20/22 expression on disease response | Up to 15 years | Will be analyzed with descriptive statistics, including evaluations of median, minimum and peak values. Correlations between quantitative variables will be done with Spearman's correlation test, whereas correlation between categorical variables will be done using Fisher's exact test. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R01CA276374 | Trispecific CAR-T cells targeting CD19, CD20 and CD22 to treat B-cell malignancies | VASU, SUMITHIRA; ALINARI, LAPO; DE LIMA, MARCOS | OHIO STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 2023 to 2025 |
Source NIH RePORTER
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/NCT05418088
GET https://conductscience.org/api/trials/v1/NCT05418088/registered