Trial Outcomes & Findings for Assessment of Donor Derived Cell Free DNA and Utility in Lung Transplantation (NCT NCT04318587)

NCT ID: NCT04318587

Last Updated: 2024-03-25

Results Overview

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen). Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F \> 300 Grade 2: Opacifications and P:F \>200, \< 300 Grade 3: Opacifications and P:F \< 200 If someone requires ECMO, they are automatically a grade 3.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 24 hours post transplant
• Results posted on: 2024-03-25

Participant Flow

Participant milestones

Measure	Allosure Arm All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
Overall Study STARTED	40
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
Age, Categorical <=18 years	0 Participants n=40 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=40 Participants
Age, Categorical >=65 years	14 Participants n=40 Participants
Sex: Female, Male Female	17 Participants n=40 Participants
Sex: Female, Male Male	23 Participants n=40 Participants
Region of Enrollment United States	40 participants n=40 Participants

PRIMARY outcome

Timeframe: 24 hours post transplant

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen).

Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200

If someone requires ECMO, they are automatically a grade 3.

Outcome measures

Measure	Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant PGD 1	15 Participants
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant PGD 2	2 Participants
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 24 Hours Post Transplant PGD 3	8 Participants

PRIMARY outcome

Timeframe: 48 hours post transplant

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen).

Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200

If someone requires ECMO, they are automatically a grade 3.

Outcome measures

Measure	Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant PGD 1	19 Participants
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant PGD 2	1 Participants
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 48 Hours Post Transplant PGD 3	10 Participants

PRIMARY outcome

Timeframe: 72 hours post transplant

Primary Graft Dysfunction is measured using a combination of radiographic opacification and P:F ratio (ratio of partial pressure of oxygen related to fraction of inhaled oxygen).

Grade 0: No opacifications on CXR Grade 1: Opacifications and P:F > 300 Grade 2: Opacifications and P:F >200, < 300 Grade 3: Opacifications and P:F < 200

If someone requires ECMO, they are automatically a grade 3.

Outcome measures

Measure	Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant PGD 1	15 Participants
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant PGD 2	1 Participants
Number of Participants With Primary Graft Dysfunction/Allograft Rejection 72 Hours Post Transplant PGD 3	11 Participants

PRIMARY outcome

Timeframe: 3 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Outcome measures

Measure

Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Number of Participants With Allograft Rejection 3 Months Post Transplant

6 Participants

PRIMARY outcome

Timeframe: 6 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Outcome measures

Measure

Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Number of Participants With Allograft Rejection 6 Months Post Transplant

0 Participants

PRIMARY outcome

Timeframe: 9 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Outcome measures

Measure

Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Number of Participants With Allograft Rejection 9 Months Post Transplant

0 Participants

PRIMARY outcome

Timeframe: 12 months post transplant

Number of participants that experienced allograft rejection determined by evaluation of biopsy taken during bronchoscopy.

Outcome measures

Measure

Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Number of Participants With Allograft Rejection 12 Months Post Transplant

0 Participants

PRIMARY outcome

Timeframe: pre-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) Pre-Transplant

Outcome measures

Measure

Allosure Arm n=34 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) Pre-Transplant

0.014 %dd-cfDNA Standard Deviation 0.05

PRIMARY outcome

Timeframe: 24 hours post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=34 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 24 Hours Post Transplant

15.4 %dd-cfDNA Standard Deviation 4.5

PRIMARY outcome

Timeframe: 48 hours post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=35 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 48 Hours Post Transplant

11.56 %dd-cfDNA Standard Deviation 5.23

PRIMARY outcome

Timeframe: 72 hours post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=35 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 72 Hours Post Transplant

8.41 %dd-cfDNA Standard Deviation 3.85

PRIMARY outcome

Timeframe: 1 week post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=37 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 1 Week Post Transplant

5.08 %dd-cfDNA Standard Deviation 2.30

PRIMARY outcome

Timeframe: 2 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Amount of Allosure Donor Derived Cell Free DNA (dd-cDNA) 2 Weeks Post Transplant

Outcome measures

Measure

Allosure Arm n=35 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 2 Weeks Post Transplant

4.84 %dd-cfDNA Standard Deviation 16.04

PRIMARY outcome

Timeframe: 3 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=29 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 3 Weeks Post Transplant

2.32 %dd-cfDNA Standard Deviation 1.35

PRIMARY outcome

Timeframe: 4 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=20 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Weeks Post Transplant

2.58 %dd-cfDNA Standard Deviation 2.09

PRIMARY outcome

Timeframe: 5 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=23 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Weeks Post Transplant

2.09 %dd-cfDNA Standard Error 1.33

PRIMARY outcome

Timeframe: 6 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=15 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Weeks Post Transplant

1.43 %dd-cfDNA Standard Deviation 0.87

PRIMARY outcome

Timeframe: 7 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=14 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Weeks Post Transplant

1.06 %dd-cfDNA Standard Deviation 0.67

PRIMARY outcome

Timeframe: 8 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=9 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Weeks Post Transplant

0.91 %dd-cfDNA Standard Deviation 0.49

PRIMARY outcome

Timeframe: 9 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=14 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Weeks Post Transplant

0.85 %dd-cfDNA Standard Deviation 0.50

PRIMARY outcome

Timeframe: 10 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=14 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Weeks Post Transplant

0.74 %dd-cfDNA Standard Deviation 0.49

PRIMARY outcome

Timeframe: 11 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=11 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Weeks Post Transplant

0.89 %dd-cfDNA Standard Deviation 0.49

PRIMARY outcome

Timeframe: 12 weeks post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=14 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Weeks Post Transplant

1.04 %dd-cfDNA Standard Deviation 1.01

PRIMARY outcome

Timeframe: 4 months post transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=16 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 4 Months Post Transplant

0.85 %dd-cfDNA Standard Deviation 1.04

PRIMARY outcome

Timeframe: 5 months post transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=15 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 5 Months Post Transplant

0.67 %dd-cfDNA Standard Deviation 0.53

PRIMARY outcome

Timeframe: 6 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=16 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 6 Months Post Transplant

0.92 %dd-cfDNA Standard Deviation 0.86

PRIMARY outcome

Timeframe: 7 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=8 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 7 Months Post Transplant

1.01 %dd-cfDNA Standard Deviation 1.58

PRIMARY outcome

Timeframe: 8 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=8 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 8 Months Post Transplant

0.50 %dd-cfDNA Standard Deviation 0.58

PRIMARY outcome

Timeframe: 9 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=5 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 9 Months Post Transplant

0.92 %dd-cfDNA Standard Deviation 0.66

PRIMARY outcome

Timeframe: 10 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=7 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 10 Months Post Transplant

0.67 %dd-cfDNA Standard Deviation 0.61

PRIMARY outcome

Timeframe: 11 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=8 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 11 Months Post Transplant

0.67 %dd-cfDNA Standard Deviation 0.39

PRIMARY outcome

Timeframe: 12 months post-transplant

dd-cDNA is fragmented DNA that originates from cells and is released into the bloodstream. This fragmented DNA is donor/recipient specific. The Allosure test is able to measure the specific amount of DNA derived from the donor cells.

Outcome measures

Measure

Allosure Arm n=16 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Amount of Allosure Donor Derived Cell Free DNA (Dd-cDNA) 12 Months Post Transplant

0.56 %dd-cfDNA Standard Deviation 0.83

SECONDARY outcome

Timeframe: one year post transplant

The number of participants that were diagnosed as having chronic lung allograft dysfunction (CLAD), needed re-transplanted or died before 1 year post transplant.

Outcome measures

Measure

Allosure Arm n=40 Participants All subjects will be in arm one and will have AlloSure blood draws at multiple time points. Allosure: Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.

Number of Participants That Experienced Graft Failure or Death Within One Year Post Transplant

0 Participants

Adverse Events

Allosure Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Naomi Ryssel

University of Pittsburgh

Phone: 412-335-9688

Email: agostinonr@upmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place