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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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

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

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 more

Awards & 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