← Back to Search

Monoclonal Antibodies

AFM13 + AB-101 for Lymphoma (LuminICE-203 Trial)

Phase 2

Recruiting

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 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a potential new treatment for classical Hodgkin's lymphoma and CD30-positive peripheral T-cell lymphoma.

Who is the study for?

This trial is for adults with relapsed or refractory Hodgkin's Lymphoma (HL) or certain types of Peripheral T-Cell Lymphoma (PTCL) that are CD30-positive. Participants must have undergone specific previous treatments, including chemotherapy and possibly stem cell transplants. They cannot join if they've had a solid organ transplant, severe autoimmune disease, another cancer within the last 2 years, active brain metastasis, or untreated HIV/Hepatitis B/C.

What is being tested?

The study tests AFM13 combined with AB-101 to evaluate their safety and effectiveness in treating HL and PTCL. It includes an initial safety review followed by expansion cohorts where more participants receive the treatment. The trial involves multiple centers and is open-label, meaning both researchers and participants know what treatment is being given.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever or fatigue due to interleukin-2 (IL-2), infusion-related reactions from monoclonal antibodies like AFM13, as well as possible effects from chemotherapy agents cyclophosphamide and fludarabine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and tumor assessment performed every 6 weeks for 3 cycles, if no disease progression on completion of treatment, then every 3 months for the first 12 months and then every 6 months (up to 24 months) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Objective Response Rate by Independent Radiology Committee

Secondary study objectives

Complete response rate (CRR) by Investigator and Independent Radiology Committee

Duration of Response by Investigator and Independent Radiology Committee

Immunogenicity assessment of AFM13 in combination with AB-101

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Safety run-in in Hodgkin LymphomaExperimental Treatment5 Interventions

4 safety run-in cohorts: * Cohort 1: 200 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) * Cohort 2: 300 mg AFM13 + AB-101 (2 × 10e9 cells on Day 1, Day 8, Day 15) * Cohort 3: 200 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15) * Cohort 4: 300 mg AFM13 + AB-101 (4 × 10e9 cells on Day 1; 2 × 10e9 cells on Day 8, Day 15)

Group II: Exploratory: AFM13 + AB-101 on CD30-positive PTCLExperimental Treatment5 Interventions

AFM13 + AB-101 on select CD30-positive PTCL subtypes (Dose Level A or B)

Group III: Dose Level B in Hodgkin LymphomaExperimental Treatment5 Interventions

Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level B (selected from cohort 1-4 of Safety run-in)

Group IV: Dose Level A in Hodgkin LymphomaExperimental Treatment5 Interventions

Randomized Simon 2-stage design in Hodgkin Lymphoma Dose Level A (selected from cohort 1-4 of Safety run-in)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AFM13

2015