Your session is about to expire
← Back to Search
Isatuximab for Antibody-Mediated Rejection
Phase < 1
Waitlist Available
Led By Luis Angel, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 0 (visit 1), day 14 (visit 3), day 28 (visit 5), day 56 (visit 7), day 84 (visit 9)
Awards & highlights
Study Summary
This trial looks at the safety and feasibility of adding isatuximab to standard treatments for lung transplant patients w/ significant antibodies against the donor. It will study the impact on recurrence of antibodies after plasmapheresis. Isatuximab not FDA approved for this use.
Who is the study for?
This trial is for adults over 18 who are set to receive or have received a lung transplant at NYU Langone Health and need desensitization due to high antibody levels against the donor, or those with signs of antibody-mediated rejection. Participants must consent and meet specific criteria related to antibodies measured in their blood.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of adding isatuximab—a drug approved for multiple myeloma—to standard treatments for patients undergoing lung transplants with significant donor-specific antibodies, either before or after surgery.See study design
What are the potential side effects?
As an investigational treatment in this context, side effects may include reactions similar to other antibody therapies such as infusion-related symptoms, potential impact on immune response, and possible interactions with standard post-transplant care.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 0 (visit 1), day 14 (visit 3), day 28 (visit 5), day 56 (visit 7), day 84 (visit 9)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 0 (visit 1), day 14 (visit 3), day 28 (visit 5), day 56 (visit 7), day 84 (visit 9)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical Resolution, as measured by the number of participants with less than 1 episode of Antibody-mediated rejection (AMR)
Clinical Resolution, as measured by the number of participants with no presence of Donor-specific antibody (DSA)
Clinical Resolution, as measured by the number of participants with reduction of DSA titer
Secondary outcome measures
Change in effects of pre-treatment Donor-Specific-Antibodies (DSAs ) with 2001-7999 Mean fluorescent intensity (MFI) at 1:16 dilution
Change in effects of pre-treatment Donor-Specific-Antibodies (DSAs ) with <2000 Mean fluorescent intensity (MFI) at 1:16 dilution
Change in effects of pre-treatment Donor-Specific-Antibodies (DSAs ) ≥ 8000 Mean fluorescent intensity (MFI) at 1:16 dilution
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment of antibody-mediated rejectionExperimental Treatment1 Intervention
Received a lung transplant or multi-organ transplant involving a lung at NYU Langone Health. Participants will be treated with standard-of-care consisting of plasmaspheresis, IVIG, rituximab and the experimental agent, isatuximab.
Group II: Peri-transplant desensitization groupExperimental Treatment2 Interventions
Listed and will receive a lung transplant or multi-organ transplant involving a lung at NYU Langone Health that is deemed to require peri-transplant desensitization. Participants will be treated with standard-of-care consisting of plasmaspheresis, IVIG, rituximab and the experimental agent, isatuximab. Patients will be followed with standard-of-care immunologic assessment consisting of weekly DSA assessment and flow cytometry crossmatch (only in the desensitization arm). Additionally, participants will have a bone marrow biopsy with pathologic examination and cell counts performed at the time of transplant and repeated at the 30-day bronchoscopy to assess for plasma cell elimination
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Isatuximab
2016
Completed Phase 3
~370
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,755 Total Patients Enrolled
Luis Angel, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with cancer.I am HIV positive.I have an untreated infection.I have been treated with tocilizumab within the last 6 months.I have been treated with rituximab within the last 6 months.I am listed for a lung or multi-organ transplant at NYU Langone Health and need special treatment before the transplant.I am 18 years old or older.I had a lung or multi-organ transplant at NYU Langone Health.My transplant is not working well, and tests show signs of rejection.I have been diagnosed with hepatitis B.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment of antibody-mediated rejection
- Group 2: Peri-transplant desensitization group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical experiment have age restrictions?
"The age range for this clinical trial is 18 to 99 years of age."
Answered by AI
To what demographic is this clinical trial open?
"In order to take part in this research, individuals must have antibody mediated rejection and be between 18-99 years of age. This trial is only open for 6 people."
Answered by AI
Is enrollment for this research endeavor still available?
"Per the information published on clinicaltrials.gov, this trial has stopped recruiting patients as of May 8th 2023. Despite being inactive, there are still 14 other studies that require volunteers at this time."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger