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Monoclonal Antibodies

AD-PluReceptor + Tafasitamab for Autoimmune Disorders

Phase 1 & 2

Recruiting

Led By Chitra Hosing, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Inadequate response to at least 1 of the following treatments: mycophenolate, cyclophosphamide, rituximab, and/or tocilizumab

Diagnosed with active SLE

Must not have

SSc related pulmonary arterial hypertension requiring active treatment

Active infection requiring medical intervention

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Summary

"This trial is first testing the safety of tafasitamab in patients with certain diseases. Then, it will determine the best dose of a combination treatment involving AD-PluReceptor-N

Who is the study for?

This trial is for patients with autoimmune diseases like systemic sclerosis or scleroderma. Participants should have a diagnosis of these conditions and be suitable for the treatments being tested, which include chemotherapy.

What is being tested?

The study is testing AD-PluReceptor-NK cells combined with tafasitamab and lymphodepleting chemotherapy. It aims to confirm safety, find the best dose, and see if this combination can control autoimmune disorders effectively.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever or fatigue, effects from chemotherapy like nausea or hair loss, and possible infusion-related reactions due to tafasitamab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have not responded well to treatments like mycophenolate, cyclophosphamide, rituximab, or tocilizumab.

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I have been diagnosed with active systemic lupus erythematosus (SLE).

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I have been diagnosed with systemic sclerosis according to the 2013 criteria.

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My blood counts and organ functions are within normal ranges.

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My skin condition has been worsening for less than 5 years and affects my lungs.

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I am between 18 and 65 years old.

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I have been diagnosed with lupus according to the 2019 guidelines.

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I am fully active or can carry out light work.

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My skin condition has been severe and started within the last 5 years.

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I have active lupus affecting my kidneys, confirmed by a biopsy.

Exclusion Criteria

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

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I am currently being treated for high blood pressure in my lungs due to scleroderma.

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I am currently being treated for an infection.

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My scleroderma is quickly worsening, affecting my lower GI or I've had a scleroderma kidney crisis before.

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My symptoms are severe, getting worse, or not under control.

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My lung disease is getting worse quickly and is not under control.

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I have been diagnosed with antiphospholipid antibody syndrome.

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I have a serious long-term lung condition.

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I have severe heart problems due to lupus.

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I have an autoimmune disease.

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I have had cancer or a related disease before.

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I have a significant brain disorder that is currently affecting me.

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I do not have any active infections.

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I have a history of heart problems.

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I have had CAR T cell therapy or similar treatments.

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I have an autoimmune disorder but it's not lupus or scleroderma, and I need drugs to suppress my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse Event

Trial Design

3Treatment groups

Experimental Treatment

Group I: Safety Lead-InExperimental Treatment1 Intervention

Group II: Dose ExpansionExperimental Treatment3 Interventions

Group III: Dose EscalationExperimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine phosphate

2007

Completed Phase 2

~370

Tafasitamab

2016

Completed Phase 3

~630

Cyclophosphamide

2010

Completed Phase 4

~2320

0 / 25Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

3,039 Previous Clinical Trials

1,799,728 Total Patients Enrolled

Chitra Hosing, MDPrincipal InvestigatorMDAnderson Cancer Center

2 Previous Clinical Trials

70 Total Patients Enrolled

~31 spots leftby Dec 2028

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