Immunotherapy for Lymphoma
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have received any anti-cancer treatment within the two weeks before starting the trial.
What data supports the effectiveness of the treatment AFM13, Acimtamig, AFM13-NK for lymphoma?
What makes the drug AFM13 unique for treating lymphoma?
AFM13 is unique because it is a first-in-class tetravalent bispecific antibody that targets both CD30 and CD16A, enhancing the ability of natural killer (NK) cells to attack lymphoma cells. This approach differs from traditional treatments by directly engaging the immune system to fight the cancer.678910
What is the purpose of this trial?
This phase I/II trial studies the side effects and best dose of modified umbilical cord blood immune cells (natural killer \[NK\] cells) combined with the antibody AFM13 (AFM13-NK) and AFM13 alone in treating patients with CD30 positive Hodgkin lymphoma or non-Hodgkin lymphoma that has come back (recurrent) or does not respond to treatment (refractory). Immunotherapy with monoclonal antibodies, such as AFM13, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Giving AFM13 loaded with NK cells followed by AFM13 alone may kill more cancer cells and decrease cancer growth in patients with CD30 positive AFM13-NK Hodgkin and Non-Hodgkin lymphomas.
Research Team
Yago L. Nieto
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Pre-treatment
Patients receive standard of care fludarabine and cyclophosphamide intravenously
Treatment
Patients receive AFM13-NK on day 0 and AFM13 on days 7, 14, and 21
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AFM13
- AFM13-NK
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor