Trial · NCT07911540
Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy
NCT07911540, Not applicable, Not yet recruiting, Wake Forest University Health Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy. Trials, record NCT07911540. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07911540
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Wearable Core Body Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Outpatients Receiving CAR T-Cell Therapy
- NCT number
- NCT07911540
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 105 participants, estimated
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Myeloma
- Interventions
- TempShield Continuous Temperature Monitoring, Standard of Care
- First posted
- 2026-11-02
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to first recorded temperature elevation indicative of Cytokine Release Syndrome (CRS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Time (in hours) from the initiation of CAR-T infusion to the first occurrence of a recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Participants who do not experience this defined temperature elevation within the 14 days will be censored at the time of their last recorded temperature reading during this window. Reported by arm. |
| Secondary | Incidence of temperature elevation indicative of Cytokine Release Syndrome (CRS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of participants who experience at least one recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Incidence of high-grade (grade 2 or higher) Cytokine Release Syndrome (CRS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of participants who experience grade 2 or higher CRS during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Time to resolution of Cytokine Release Syndrome (CRS) from temper elevation indicative of CRS (temperature ≥ 100.4 °F) | From the temperature elevation (≥ 100.4 °F) to resolution during the 14 days after CAR-T infusion. | Time (in hours) from the from onset of fever indicative of CRS (temperature ≥ 100.4 °F) during the 14-day post-CAR-T observation period to resolution (i.e., when the participant no longer meets the CRS diagnostic criteria). If a participant experiences multiple episodes of CRS during the 14-day post-CAR-T observation period, the duration can be calculated per episode and cumulatively. This will be calculated for participants experiencing CRS (temperature ≥ 100.4 °F) during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Time to intervention after fever detection (temperature ≥ 100.4 °F) | From the temperature elevation (≥ 100.4 °F) to intervention during the 14 days after CAR-T infusion. | Time (in hours) from documented temperature elevation of ≥ 100.4° F to clinician intervention (e.g., supportive care, medication followed by observation, etc.). This will be calculated for participants experiencing CRS during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Incidence of admission to the Intensive Care Unit (ICU) due to temperature elevation indicative of CRS | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of participants admitted to the ICU due to temperature elevation indicative of CRS during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Time to discharge after admission to the Intensive Care Unit (ICU) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Time (in hours) from ICU admission to ICU discharge. If a participant has multiple ICU admissions during the 14-day post-CAR-T observation period, the duration will be calculated cumulatively. Reported by arm. |
| Secondary | Length of hospital stay | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of inpatient nights from hospital admission to hospital discharge due to temperature elevation indicative of CRS during the 14-day post-CAR-T observation period. If a participant has multiple hospital admissions due to CRS during the 14-day post-CAR-T observation period, the duration reported will be cumulative across all stays. This endpoint will be calculated for participants admitted to this hospital during the 14-day post-CAR-T observation period due to temperature elevation indicative of CRS. Reported by arm. |
| Secondary | Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) | From the initiation of CAR-T infusion up to Day 14 post-infusion. | Number of participants experiencing ICANS during the 14-day post-CAR-T observation period. Reported by arm. |
| Secondary | Largest change in body temperature from baseline recorded during the 14-day post-CAR-T observation period | From the initiation of CAR-T infusion up to Day 14 post-infusion. | The maximum numerical difference in body temperature recorded from baseline during the 14-day post-CAR-T observation period. Reported by arm. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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/NCT07911540
GET https://conductscience.org/api/trials/v1/NCT07911540/registered