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CAR T-cell Therapy
CAR T-Cell Therapy for Chronic Graft Versus Host Disease
Phase 1
Recruiting
Led By Amandeep Salhotra
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Creatinine clearance of >= 30 mL/min per 24-hour urine test or the Cockcroft-Gault formula (performed within 28 days prior to enrollment)
Exposure to at least 1 of the Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI) therapies for cGVHD
Must not have
Active uncontrolled infection requiring systemic antibiotics and/or anti-virals
Unstable cardiac disease as defined by one of the following: Cardiac events such as myocardial infarction (MI) within the past 6 months, NYHA (New York Heart Association) heart failure class III-IV, Uncontrolled atrial fibrillation or hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from infusion of cd6-car tregs to start of new treatment for cgvhd, recurrence of malignancy, or death, whichever comes first, assessed at week 12 and 1-year follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new CAR T-cell therapy to improve tolerance and control of chronic GVHD after stem cell transplantation.
Who is the study for?
Adults with chronic graft versus host disease after a stem cell transplant from a related or haploidentical donor, who have tried at least one FDA-approved therapy and are not responding well to steroids. They must be in relatively good health otherwise, understand the study, consent to it, and agree to use birth control. People with uncontrolled illnesses, recent vaccines, other investigational treatments, unstable heart conditions or active infections can't join.
What is being tested?
The trial is testing CD6-CAR T regulatory cells for patients with chronic GVHD post-transplantation. It aims to see if these engineered immune cells can help control autoimmune responses by increasing T regulatory cells that maintain immune balance. The process involves various assessments like MRI and CT scans before infusing the modified T cells back into the patient.
What are the potential side effects?
Potential side effects may include reactions at the infusion site, increased risk of infection due to immune system modification, fatigue, fever and chills during infusion. There could also be unforeseen complications since this is an early-phase trial exploring new treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function, measured by creatinine clearance, is adequate.
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I have been treated with an FDA-approved TKI for cGVHD.
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My heart's electrical activity is normal, with a QTc of ≤ 480 msec.
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I am 18 years old or older.
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My white blood cell count is healthy without needing medication in the past week.
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My viral load is undetectable for HIV, HCV, or HBV.
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I've been on a stable dose of corticosteroids not exceeding 15mg/day of prednisone or equivalent, and up to 7ng/mL/day sirolimus for at least 14 days.
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My graft-versus-host disease is severe and doesn't respond well to steroids.
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I received a stem cell transplant from a related donor for my blood disorder.
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I have not received anti-CD6 therapy after my last stem cell transplant.
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I am 18 years old or older.
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I am able to care for myself but may not be able to do active work.
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I am able to care for myself but may not be able to do active work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently fighting an infection that needs strong medication.
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I do not have recent heart issues, severe heart failure, or uncontrolled heart rhythm/blood pressure problems.
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I do not have any uncontrolled serious illnesses.
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I am not pregnant or breastfeeding.
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I have had a blood clot or stroke in the past.
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I have no allergies or adverse reactions to steroids or tocilizumab.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from infusion of cd6-car tregs to start of new treatment for cgvhd, recurrence of malignancy, or death, whichever comes first, assessed at week 12 and 1-year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from infusion of cd6-car tregs to start of new treatment for cgvhd, recurrence of malignancy, or death, whichever comes first, assessed at week 12 and 1-year follow-up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicity
Feasibility as the ability to meet the required produce release criteria
Feasibility as the ability to met at least 80% of the required cell dose at the assigned dose level
Secondary study objectives
CD6-CAR Treg activity
CD6-CAR Treg persistence
Changes in cGVHD severity
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (CD6-CAR Treg, tafasitamab)Experimental Treatment12 Interventions
Donors undergo leukapheresis over 2-4 hours for collection of PBMSc and the manufacturing of CD6-CAR Treg cells over 2 weeks. Patients then receive CD6-CAR Treg intravenously on day 0. Patients may also receive ablation tafasitamab IV post Treg cell infusion on days 1, 4, 8, 15, 22 for 1 cycle. If ablation is not complete by day 28, patients may receive an additional 1-2 cycles per investigator's discretion. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO, CT, and x-ray imaging during screening and as clinically indicated. Patients undergo blood specimen collection on study and during follow-up. Patients may undergo a biopsy on study as well as a lumbar puncture and MRI/CT as clinically indicated on study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Computed Tomography
2017
Completed Phase 2
~2740
Echocardiography
2013
Completed Phase 4
~11580
Lumbar Puncture
2016
Completed Phase 3
~510
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Tafasitamab
2016
Completed Phase 3
~630
Leukapheresis
2016
Completed Phase 2
~710
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,553 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,927 Previous Clinical Trials
41,017,978 Total Patients Enrolled
1 Trials studying GVHD
30 Patients Enrolled for GVHD
Amandeep SalhotraPrincipal InvestigatorCity of Hope Medical Center
4 Previous Clinical Trials
101 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Women who can have children must have a recent negative pregnancy test before joining the study. If the urine test is positive or not clear, a blood test will be needed.You are currently taking other experimental drugs or biologic treatments.I have been treated with an FDA-approved TKI for cGVHD.My heart's electrical activity is normal, with a QTc of ≤ 480 msec.I am 18 years old or older.My kidney function, measured by creatinine clearance, is adequate.You tested negative for COVID-19 within the three days before starting the treatment in the study.I have no active cancer except for skin cancer.I am currently fighting an infection that needs strong medication.I do not have recent heart issues, severe heart failure, or uncontrolled heart rhythm/blood pressure problems.My white blood cell count is healthy without needing medication in the past week.My viral load is undetectable for HIV, HCV, or HBV.You need to have a recent negative test for tuberculosis. If your test is positive, you need approval from an infectious disease doctor before you can join the study.My donor has passed all required checks and tests for my treatment.My oxygen level is 92% or higher, or my lung function test score is at least 40% of the expected.I've been on a stable dose of corticosteroids not exceeding 15mg/day of prednisone or equivalent, and up to 7ng/mL/day sirolimus for at least 14 days.I have not received any vaccines in the last 28 days.My graft-versus-host disease is severe and doesn't respond well to steroids.I received a stem cell transplant from a related donor for my blood disorder.I do not have any uncontrolled serious illnesses.I have not received anti-CD6 therapy after my last stem cell transplant.I am not pregnant or breastfeeding.I am 18 years old or older.Your total bilirubin levels should be less than or equal to 2 mg/dL, unless you have Gilbert's syndrome or liver issues related to cGVHD. This test should be done within 28 days before joining the study.Your heart's pumping function is good, and it's been checked within the last 28 days.I am able to care for myself but may not be able to do active work.I am able to care for myself but may not be able to do active work.Your liver test results (ALT) must be within a certain range.I received a donor lymphocyte infusion less than 100 days ago.I haven't taken immunosuppressive drugs, except corticosteroids, in the last 28 days.You do not have HIV, hepatitis C, active hepatitis B, or syphilis.I have had a blood clot or stroke in the past.You have had allergic reactions to drugs that are similar to the study drug.Your AST levels are not more than 3 times the upper limit of normal within the last 28 days.Your platelet count is at least 50,000 per cubic millimeter and you haven't received a platelet transfusion in the last 14 days.You are expected to live for more than 90 days.I have no allergies or adverse reactions to steroids or tocilizumab.I have an autoimmune or inflammatory disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (CD6-CAR Treg, tafasitamab)
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.
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