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Monoclonal Antibodies

AFM13 for T-cell Lymphoma (REDIRECT Trial)

Phase 2

Waitlist Available

Led By Won Seog Kim, Dr

Research Sponsored by Affimed GmbH

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).

Awards & highlights

REDIRECT Trial Summary

This trial is testing a new cancer treatment, AFM13, to see if it is effective and safe for patients with T-cell lymphoma who have CD30-positive tumors.

Eligible Conditions

Peripheral T-Cell Lymphoma
Mycosis Fungoides

REDIRECT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months).

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessment performed every 8 weeks for first 3 assessments, then every 12 weeks until documented disease progression (up to 28 months). for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Response Rate Assessed by Independent Review Committee Based on PET-CT

Secondary outcome measures

Area Under the Concentration-Time Curve of AFM13 From 0 to Infinity (AUC 0-∞)

Complete Response Rate and Partial Response Rate Assessed by Independent Review Committee Based on PET-CT

Complete Response Rate, Partial Response Rate and Overall Response Rate Assessed by Independent Review Committee Based on CT

+12 more

Side effects data

From 2024 Phase 2 trial • 108 Patients • NCT04101331

23%

Infusion related reaction

19%

Pyrexia

16%

Rash

15%

Anaemia

13%

Neutropenia

12%

Thrombocytopenia

12%

Constipation

11%

Diarrhoea

10%

Nausea

Abdominal pain

Erythema

Headache

Asthenia

COVID-19

Cough

Arthralgia

Vomiting

Hypokalaemia

Insomnia

Dyspnoea

Oropharyngeal pain

Blood lactate dehydrogenase increased

Dyspepsia

Upper respiratory tract infection

Pruritus

Lymphopenia

Chills

Decreased appetite

Hypomagnesaemia

Pneumonia

Acute kidney injury

Acute respiratory distress syndrome

Herpes zoster

Septic shock

Periodontitis

Vascular access site infection

Clostridium difficile colitis

Cytomegalovirus infection reactivation

Rhinovirus infection

Soft tissue infection

Staphylococcal sepsis

Streptococcal bacteraemia

Orchitis

Haemoptysis

Pulmonary embolism

COVID-19 pneumonia

Pneumonia aspiration

Respiratory tract infection

Enterococcal bacteraemia

General physical health deterioration

Pulmonary haemorrhage

Pulmonary oedema

Pain

Acute left ventricular failure

Cardiomyopathy

Hepatic enzyme increased

International normalised ratio increased

Dehydration

Hyponatraemia

Cancer pain

Diffuse large B-cell lymphoma

Disseminated intravascular coagulation

Back pain

Ischaemic cerebral infarction

Superior vena cava syndrome

100%

80%

60%

40%

20%

Study treatment Arm

Cohort A

REDIRECT Trial Design

1Treatment groups

Experimental Treatment

Group I: Cohort AExperimental Treatment1 Intervention

Subjects with Relapsed or Refractory CD30 positive Peripheral T-cell Lymphoma (PTCL).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AFM13

2015

Completed Phase 2

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Affimed GmbHLead Sponsor

10 Previous Clinical Trials

562 Total Patients Enrolled

Karenza Alexis, MDStudy DirectorAffimed Inc.

1 Previous Clinical Trials

154 Total Patients Enrolled

Won Seog Kim, DrPrincipal InvestigatorSamsung Medical Center

Media Library

AFM13 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04101331 — Phase 2

Frequently Asked Questions

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

Is there a high potential for adverse effects from AFM13?

"AFM13 is still being clinically tested for both safety and efficacy. Thus far, there is evidence supporting safety but not yet efficacy. Consequently, we have rated AFM13 a 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides

2019. "Phase II Study to Assess AFM13 in Patients With R/R CD30-positive T-cell Lymphoma or Transformed Mycosis Fungoides". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04101331.