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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

LuminICE-203 Trial 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.Check my eligibility

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.See study design

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.

LuminICE-203 Trial 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

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

Primary outcome measures

Objective Response Rate by Independent Radiology Committee

Secondary outcome measures

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

LuminICE-203 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

Completed Phase 2

~180

AB-101

2018

Completed Early Phase 1

~10

Cyclophosphamide

1995

Completed Phase 3

~3770

Fludarabine

2012

Completed Phase 3

~1100

Interleukin-2

1994

Completed Phase 3

~700

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Affimed GmbHLead Sponsor

10 Previous Clinical Trials

516 Total Patients Enrolled

Artiva Biotherapeutics, Inc.Industry Sponsor

3 Previous Clinical Trials

259 Total Patients Enrolled

Karenza Alexis, MDStudy DirectorAffimed Inc.

1 Previous Clinical Trials

108 Total Patients Enrolled

Frequently Asked Questions

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

What is the current enrollment capacity of this research program?

"Affirmative. Clinicaltrials.gov hosts evidence that this scientific investigation is actively seeking for volunteers, having first been posted on October 10th 2023 and updated most recently on the 12th of the same month. 154 participants need to be recruited from a single medical site."

Answered by AI

To what extent is Safety run-in risky for patients with Hodgkin Lymphoma?

"The safety of the Safety run-in trial for Hodgkin Lymphoma is considered to be moderate – receiving a score of 2. This is due to there being some evidence supporting its security, yet none demonstrating efficacy."

Answered by AI

Is the study open for enrollment of participants at this time?

"Affirmative. Clinicaltrials.gov's data states that this clinical trial, which was initiated on October 10th of 2023, is recruiting patients. A total of 154 participants are needed for the study at a single medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL

2023. "Phase 2 Study of AFM13 in Combination With AB-101 in Subjects With R/R HL and CD30+ PTCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05883449.