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Monoclonal Antibodies

Immunotherapy for Lymphoma

Phase 1 & 2

Waitlist Available

Led By Yago L Nieto

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

No uncontrolled arrhythmias or symptomatic cardiac disease.

Karnofsky performance status >= 60%.

Must not have

Human immunodeficiency virus (HIV) infection.

Previous treatment with AFM13.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immunotherapy treatment for Hodgkin and non-Hodgkin lymphomas that has come back or does not respond to treatment. The treatment is a combination of modified immune cells and an antibody. The trial will test the side effects and best dose of the treatment.

Who is the study for?

This trial is for patients with recurrent or refractory CD30 positive Hodgkin or non-Hodgkin lymphomas who have adequate organ function and performance status. Women of childbearing potential must not be pregnant, breastfeeding, and agree to use contraception. Exclusions include unresolved severe side effects from prior treatments, active infections requiring IV antibiotics, HIV infection, recent major surgery, other active malignancies (except certain skin cancers), and life expectancy under 6 months.

What is being tested?

The trial is testing modified NK cells combined with the monoclonal antibody AFM13 (AFM13-NK) followed by AFM13 alone in patients with specific types of lymphoma. The goal is to determine the best dose and observe how well this combination helps the immune system attack cancer cells and potentially reduce tumor growth.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as inflammation in various organs due to NK cell activity or infusion-related reactions from the monoclonal antibody AFM13. Other common side effects could involve fatigue, blood disorders like anemia or clotting issues, as well as increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any heart rhythm problems that aren't under control.

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I can 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 HIV positive.

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I have been treated with AFM13 before.

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I haven't taken any cancer treatment, including trials, in the last 2 weeks.

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I have not had major surgery within the last 4 weeks.

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I am currently on IV antibiotics for an infection.

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I have severe side effects from previous treatments that haven't improved.

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I do not have active hepatitis B or C.

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I have untreated brain metastasis or positive spinal fluid test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Secondary study objectives

Complete response (CR) rate

Event-free survival

Immune reconstitution studies

+4 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 (AFM13-NK, AFM13)Experimental Treatment5 Interventions

Patients receive standard of care fludarabine IV over 1 hour and standard of care cyclophosphamide IV over 30-60 minutes on days -5 to -3, AFM13-NK IV over 4 hours on day 0, and then AFM13 IV over 4 hours on days 7, 14, and 21.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine

2012

Completed Phase 4

~1860