Pulmonary ComplicationsCAR-T PULMOXNCT07794423
Pulmonary Complications of CAR T-cell Therapy
An observational study of Pulmonary Complications and CAR-T Cells, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Background and Rationale Chimeric Antigen Receptor (CAR) T-cell therapies are emerging as a revolutionary treatment for hematological malignancies. However, this treatment carries a non-negligible clinical risk of pulmonary complications, which present as varied syndromes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Complications, CAR-T Cells
- How many people
- 266 participants
- Where
- 1 siteFrance
- Study dates
- 2 Dec 2024to 22 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To be included in the study, patients must meet all of the following criteria: * Be an adult (Majeur). * Have received CAR T-cell based therapy. * Received this therapy at the Hematology department of Lyon Sud (CHLS). * Have a minimum of 2 years of follow-up data available at the time of the data collection start date.
Who may be able to join
- • Be an adult (Majeur).
- Have received CAR T-cell based therapy.
- Received this therapy at the Hematology department of Lyon Sud (CHLS).
- Have a minimum of 2 years of follow-up data available at the time of the data collection start date.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early and Late Pulmonary Complications of CAR T-cell Therapy
Background and Rationale Chimeric Antigen Receptor (CAR) T-cell therapies are emerging as a revolutionary treatment for hematological malignancies. However, this treatment carries a non-negligible clinical risk of pulmonary complications, which present as varied syndromes. These range from acute disorders, such as Cytokine Release Syndrome (CRS) with respiratory distress (ARDS), to interstitial lung diseases, as well as opportunistic and community-acquired infections related to treatment-induced immunosuppression. A better understanding of these pulmonary complications is necessary to identify predictive and risk factors. This knowledge is essential to guide the development of potential prevention strategies.
Objectives The primary objective of this study is to describe the early and late pulmonary complications associated with CAR T-cell therapies. The primary endpoint is the incidence and nature of pulmonary complications occurring early (≤30 days post-reinjection) and late (>30 days up to 2 years) after treatment.
Read more
Secondary objectives include:
- Investigating associations between patient characteristics or follow-up data and the onset of complications through exploratory analyses.
- Describing the prevalence of risk factors.
- Describing complication rates according to per-procedure data (e.g., pre-CAR-T lymphocyte count, duration of aplasia).
- Analyzing complication incidence by calendar periods of reinjection to study the evolution of practices.
- Describing survival curves based on different variables. Methods This is a descriptive, retrospective cohort study. The study will analyze data from all adult patients (expected n=266) who received CAR T-cell therapy at the Hematology Department of Lyon Sud Hospital (CHLS) and who have at least two years of follow-up data collected.
Patient data from January 9, 2017, to January 1, 2025, will be collected from medical records. Statistical analysis will include comparisons of continuous variables (Wilcoxon or Student's t-test) and categorical variables (Chi-squared or Fisher's exact test). Survival will be represented using Kaplan-Meier curves and compared with the Log-Rank test. Univariate and multivariate logistic regression models will be used to identify associations, with a Bonferroni correction applied for multiple tests.
Expected Outcomes The findings are expected to help identify predictive factors for pulmonary complications. This may lead to modified recommendations for pre-CAR-T cell assessments and adaptations to patient follow-up protocols.
- Conditions
- Pulmonary Complications, CAR-T Cells
- Being tested
- No intervention for the patient, study on medical records
- Keywords
- CAR-T cells, pulmonary complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention for the patient, study on medical recordsOther
No intervention for the patient, study on medical records
| Study group | Role | What they receive |
|---|---|---|
| Patient who have received CAR-T cells therapy | * Be an adult (Majeur).
* Have received CAR T-cell based therapy.
* Received this therapy at the Hematology department of Lyon Sud (CHLS).
* Have a minimum of 2 years of follow-up data available at the time of the data collection start date. Receives: Other: No intervention for the patient, study on medical records |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the early and late pulmonary complications associated with CAR T-cell therapies
incidence and nature of pulmonary complications occurring early (≤30 days post-reinjection) and late (>30 days up to 2 years) after treatment.
Measured: Day 0 through Day 720 after CAR-T cell injection with two pre-specified periods after CAR T-cell infusion: early, Day 0 through Day 30; late, Day 31 through Day 730 (2 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study start2 Dec 2024
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07794423
- Sponsor's protocol ID
- 25-5347
- Acronym
- CAR-T PULMOX
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early and Late Pulmonary Complications of CAR T-cell Therapy
- ClinicalTrials.gov ID
- NCT07794423
- Acronym / sponsor ID
- CAR-T PULMOX / 25-5347
- Conditions
- Pulmonary Complications, CAR-T Cells
- Keywords
- CAR-T cells, pulmonary complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 2 Dec 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background and Rationale Chimeric Antigen Receptor (CAR) T-cell therapies are emerging as a revolutionary treatment for hematological malignancies. However, this treatment carries a non-negligible clinical risk of pulmonary complications, which present as varied syndromes. These range from acute disorders, such as Cytokine Release Syndrome (CRS) with respiratory distress (ARDS), to interstitial lung diseases, as well as opportunistic and community-acquired infections related to treatment-induced immunosuppression. A better understanding of these pulmonary complications is necessary to identify predictive and risk factors. This knowledge is essential to guide the development of potential prevention strategies.
Objectives The primary objective of this study is to describe the early and late pulmonary complications associated with CAR T-cell therapies. The primary endpoint is the incidence and nature of pulmonary complications occurring early (≤30 days post-reinjection) and late (>30 days up to 2 years) after treatment.
Secondary objectives include:
- Investigating associations between patient characteristics or follow-up data and the onset of complications through exploratory analyses.
- Describing the prevalence of risk factors.
- Describing complication rates according to per-procedure data (e.g., pre-CAR-T lymphocyte count, duration of aplasia).
- Analyzing complication incidence by calendar periods of reinjection to study the evolution of practices.
- Describing survival curves based on different variables. Methods This is a descriptive, retrospective cohort study. The study will analyze data from all adult patients (expected n=266) who received CAR T-cell therapy at the Hematology Department of Lyon Sud Hospital (CHLS) and who have at least two years of follow-up data collected.
Patient data from January 9, 2017, to January 1, 2025, will be collected from medical records. Statistical analysis will include comparisons of continuous variables (Wilcoxon or Student's t-test) and categorical variables (Chi-squared or Fisher's exact test). Survival will be represented using Kaplan-Meier curves and compared with the Log-Rank test. Univariate and multivariate logistic regression models will be used to identify associations, with a Bonferroni correction applied for multiple tests.
Expected Outcomes The findings are expected to help identify predictive factors for pulmonary complications. This may lead to modified recommendations for pre-CAR-T cell assessments and adaptations to patient follow-up protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient who have received CAR-T cells therapy | – | Other: No intervention for the patient, study on medical records* Be an adult (Majeur). * Have received CAR T-cell based therapy. * Received this therapy at the Hematology department of Lyon Sud (CHLS). * Have a minimum of 2 years of follow-up data available at the time of the data collection start date. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be included in the study, patients must meet all of the following criteria: * Be an adult (Majeur). * Have received CAR T-cell based therapy. * Received this therapy at the Hematology department of Lyon Sud (CHLS). * Have a minimum of 2 years of follow-up data available at the time of the data collection start date.
Key inclusion criteria (4 listed)
- • Be an adult (Majeur).
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention for the patient, study on medical recordsNo intervention for the patient, study on medical records | Other | Patient who have received CAR-T cells therapy |
Primary outcome
Describe the early and late pulmonary complications associated with CAR T-cell therapies
Time frame: Day 0 through Day 720 after CAR-T cell injection with two pre-specified periods after CAR T-cell infusion: early, Day 0 through Day 30; late, Day 31 through Day 730 (2 years).
incidence and nature of pulmonary complications occurring early (≤30 days post-reinjection) and late (>30 days up to 2 years) after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Complications and CAR-T Cells, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the early and late pulmonary complications associated with CAR T-cell therapies (time frame: Day 0 through Day 720 after CAR-T cell injection with two pre-specified periods after CAR T-cell infusion: early, Day 0 through Day 30; late, Day 31 through Day 730 (2 years).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.