Trial · NCT07162038
Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation
NCT07162038, Phase 1, Recruiting, National Cancer Institute (NCI)
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation. Trials, record NCT07162038. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07162038
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation
- NCT number
- NCT07162038
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 155 participants, estimated
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Hematologic Malignancies, Hematologic Neoplasms
- Interventions
mCD19-CAR-CD28-CD3-zeta.(anti-CD19 CAR) retroviral vector-transduced allogeneic peripheral blood lymphocytes (PBL), Fludarabine, Cyclophosphamide, Mycophenolate Mofetil, Sirolimus, CD19 Flow Cytometry Assay, CD19 Immunohistochemical Assay, Total Body Irradiation
- First posted
- 2025-09-09
- Last updated
- 2026-10-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Identify the safety of anti-CD19 CAR T-cell therapy in combination with HLA-haploidentical HCT in participants with high risk CD19+ hematologic malignancies | 28 days (or 35 days for alternate dose levels) | Determine the fraction of evaluable recipient participants at each dose level who experience a dose-limiting toxicity (DLT). |
| Primary | Estimate the 1 year relapse and survival outcomes at the maximum tolerated dose | 1 year | Estimates will be determined using Kaplan-Meier curves or competing risk-based cumulative incidence curves as appropriate for participants treated at the MTD and may be reported individually for the MTD and other dose levels. The results at indicated time points will be reported and may include 95% confidence intervals as appropriate. |
| Secondary | Estimate the incidence and severity of CRS and ICANS | 100 days | Rate and grade of CRS and ICANS will be measured by the maximum grade as assessed by the ASTCT Consensus Criteria for each condition and reported as fractions of those that attained each grade of severity. |
| Secondary | Estimate the incidence of Grade II-IV and Grade III-IV acute GVHD at +200 days | 200 days | Grade II-IV and III-IV aGVHD will be evaluated descriptively including fractions who attain each condition, along with 95% confidence intervals as appropriate. |
| Secondary | Estimate the incidence and severity of chronic GVHD at 1 year | 1 year | Analyses will be done numerically and using cumulative incidence curves with 95% confidence intervals at the stated time points as appropriate. |
| Secondary | Estimate incidence of primary engraftment failure and kinetics of engraftment | 60 days | Will be reported as a proportion of evaluation participants |
| Secondary | Estimate relapse/progression, non-relapse mortality, progression-free survival, and overall survival at 1 year | 1 year | Analyses will be done numerically and using cumulative incidence curves with 95% confidence intervals at the stated time points as appropriate. |
| Secondary | Estimate relapse/progression, non-relapse mortality, progression-free survival, and overall survival at 5 years | 1 year | Analyses will be done numerically and using cumulative incidence curves with 95% confidence intervals at the stated time points as appropriate. |
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.
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/NCT07162038
GET https://conductscience.org/api/trials/v1/NCT07162038/registered