Immunotherapy for Lymphoma

Recruiting in Palo Alto (17 mi)

Yago L. Nieto | MD Anderson Cancer Center

Overseen byYago L. Nieto

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Trial Summary

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.

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

Serum creatinine clearance >= 50 ml/min, estimated using the Cockcroft-Gault equation.

Alkaline phosphatase (ALP) =< 2 x ULN.

Bilirubin =< 2 x ULN.

+12 more

Exclusion Criteria

I am HIV positive.

I have been treated with AFM13 before.

I haven't taken any cancer treatment, including trials, in the last 2 weeks.

+8 more

Participant Groups

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.

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.