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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

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

Study 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.Check my eligibility

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.See study design

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 below

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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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

CD6-CAR Treg activity

CD6-CAR Treg persistence

Changes in cGVHD severity

+4 more

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

Lumbar Puncture

2016

Completed Phase 3

~510

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Computed Tomography

2017

Completed Phase 2

~2720

Echocardiography

2013

Completed Phase 4

~11670

Tafasitamab

2016

Completed Phase 2

~180

Leukapheresis

2016

Completed Phase 2

~690

Biopsy

2014

Completed Phase 4

~1090

Biospecimen Collection

2004

Completed Phase 2

~1700

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,633 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,672 Previous Clinical Trials

40,926,414 Total Patients Enrolled

1 Trials studying Graft-versus-Host Disease

236 Patients Enrolled for Graft-versus-Host Disease

Amandeep SalhotraPrincipal InvestigatorCity of Hope Medical Center

3 Previous Clinical Trials

66 Total Patients Enrolled

Media Library

CD6-CAR Tregs (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05993611 — Phase 1

Graft-versus-Host Disease Research Study Groups: Treatment (CD6-CAR Treg, tafasitamab)

Graft-versus-Host Disease Clinical Trial 2023: CD6-CAR Tregs Highlights & Side Effects. Trial Name: NCT05993611 — Phase 1

CD6-CAR Tregs (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05993611 — Phase 1

Frequently Asked Questions

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

What potential risks should patients be aware of when considering Treatment (CD6-CAR Treg, tafasitamab)?

"Given that this is still considered an early-stage trial, the safety of Treatment (CD6-CAR Treg, tafasitamab) was assigned a rating of 1. Such limited data makes it difficult to accurately assess efficacy and security."

Answered by AI

Are any additional participants allowed to enroll in the trial at this time?

"This study, which was posted on October 17th 2023 and last updated August 7th of the same year, is not actively seeking participants. Despite this inactivity, there are hundreds of other clinical trials that eagerly accept patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation

2024. "Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05993611.

All > Graft Vs Host Disease