Pulmonary Complications of CAR T-cell Therapy

NCT07794423 | Completed

• 1 other identifier: 25-5347
• Study Type: observational
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Complications; CAR-T Cells

Keywords

CAR-T cells; pulmonary complications

Outcome Measures

Primary Outcomes (1)

• 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.

  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).

Study Arms (1)

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.

Other: No intervention for the patient, study on medical records

Interventions

No intervention for the patient, study on medical records OTHER

No intervention for the patient, study on medical records

Patient who have received CAR-T cells therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• none

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Centre hospitalier Lyon Sud

Pierre-Bénite, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: August 31, 2026
• Study Start: December 2, 2024
• Primary Completion: September 22, 2025
• Study Completion: September 22, 2025
• Last Updated: August 31, 2026

Record last verified: 2026-04

Locations

FR (1)