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CAR T-cell Therapy

CAR T-Cell Therapy for Kidney Failure

Phase 2
Waitlist Available
Research Sponsored by Northside Hospital, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate bone marrow function to receive lymphodepleting chemotherapy
ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights

Study Summary

This trial studies if an advanced cancer treatment (CAR T therapy) is effective in patients with kidney problems.

Who is the study for?
This trial is for people with certain blood cancers (like multiple myeloma, leukemia, or lymphoma) who also have moderate to severe kidney problems. They must be strong enough for chemotherapy and not have central nervous system disorders, uncontrolled infections, or be taking high doses of steroids.Check my eligibility
What is being tested?
The study is testing if CAR T-cell therapy can work in patients with poor kidney function by adjusting the dose of chemo drugs Cyclophosphamide and Fludarabine used before the therapy.See study design
What are the potential side effects?
CAR T-cell therapy may cause flu-like symptoms, difficulty breathing, confusion, weakness on one side of the body, trouble speaking or thinking clearly. Chemo drugs might lead to nausea, hair loss, mouth sores and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bone marrow is healthy enough for strong chemotherapy.
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I am able to get out of my bed or chair and move around.
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My kidney function is reduced, with a filtration rate of 60 mL/min or less.
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I am getting special chemotherapy before my CAR-T cell therapy for blood cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of CRS
Occurrence of Cytopenias
Occurrence of ICANS

Trial Design

3Treatment groups
Experimental Treatment
Group I: Severe Renal DysfunctionExperimental Treatment2 Interventions
Several renal dysfunction will receive a 40% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Group II: Moderate Renal DysfunctionExperimental Treatment2 Interventions
Moderate renal dysfunction will receive a 20% dose reduction of fludarabine and no dose reduction for cyclophosphamide.
Group III: Dialysis ParticipantsExperimental Treatment2 Interventions
Participants on dialysis will receive a 50% dose reduction of fludarabine and a 25% dose reduction of cyclophosphamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

Northside Hospital, Inc.Lead Sponsor
24 Previous Clinical Trials
1,071 Total Patients Enrolled
Blood and Marrow Transplant Group of GeorgiaOTHER
8 Previous Clinical Trials
300 Total Patients Enrolled

Media Library

CAR T-cell Therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05909059 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Dialysis Participants, Moderate Renal Dysfunction, Severe Renal Dysfunction
Non-Hodgkin's Lymphoma Clinical Trial 2023: CAR T-cell Therapy Highlights & Side Effects. Trial Name: NCT05909059 — Phase 2
CAR T-cell Therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05909059 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open vacancies available to participate in this research?

"According to clinicaltrials.gov, this medical trial is not presently accepting patients. Initially posted on August 31st 2023 and last updated June 9th 2023, while the study has concluded recruitment for now, there are 1898 other studies actively looking for participants at present."

Answered by AI

What potential risks does having Moderate Renal Dysfunction pose?

"Moderate Renal Dysfunction has been assigned a score of 2, as there is evidence suggesting it to be safe but not yet any documentation that it is effective in practice."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CAR T-cell Therapy in Patients With Renal Dysfunction
2024. "CAR T-cell Therapy in Patients With Renal Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05909059.
~13 spots leftby Aug 2025
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