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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%.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

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

Primary outcome measures

Incidence of adverse events

Secondary outcome measures

Complete response (CR) rate

Duration of response

Event-free survival

+5 more

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

1995

Completed Phase 3

~3780

Fludarabine

2012

Completed Phase 3

~1100

Fludarabine Phosphate

1997

Completed Phase 3

~2390

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,751 Total Patients Enrolled

Yago L NietoPrincipal InvestigatorM.D. Anderson Cancer Center

4 Previous Clinical Trials

155 Total Patients Enrolled

Media Library

AFM13 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04074746 — Phase 1 & 2

Peripheral T-Cell Lymphoma Research Study Groups: Treatment (AFM13-NK, AFM13)

Peripheral T-Cell Lymphoma Clinical Trial 2023: AFM13 Highlights & Side Effects. Trial Name: NCT04074746 — Phase 1 & 2

AFM13 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04074746 — Phase 1 & 2

Frequently Asked Questions

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

Has AFM13's Anti-CD30/CD16A Monoclonal Antibody been tested in any prior clinical investigations?

"Currently, 889 trials are on-going to explore the efficacy of Anti-CD30/CD16A Monoclonal Antibody AFM13. Of those experiments, 161 have reached Phase 3 of testing. While most research for this treatment is situated in Philadelphia, Pennsylvania, 28443 sites across the world are running studies related to this medication."

Answered by AI

What medical conditions is Anti-CD30/CD16A Monoclonal Antibody AFM13 commonly prescribed to treat?

"Anti-CD30/CD16A Monoclonal Antibody AFM13 is the most common treatment for multiple sclerosis, although it can also provide relief to patients suffering from acute and myelocytic leukemia, mixed-cell type lymphoma, and retinoblastoma."

Answered by AI

Could I potentially join the research project?

"This trial requires 30 participants who suffer from relapse, aged 15-75. Other criteria for enrolment are having a forced vital capacity (FVC) of 50% or higher."

Answered by AI

How many participants is this research endeavor accommodating?

"Affirmative. Data hosted on clinicaltrials.gov confirms that this medical study, which was first shared on July 18th 2020, is actively recruiting participants. Approximately 30 patients need to be gathered from 1 research centre."

Answered by AI

Is the enrollment process for this trial currently open?

"As documented on clinicaltrials.gov, this clinical research is currently seeking participants. The trial was initially published on July 18th 2020, with the most recent revision made to it being August 9th 2022."

Answered by AI