Seven patients have entered this trial. All seven have had extensive therapy and are very immunosuppressed. When no side effects were noted in the first 3 patients, the protocol was modified as follows: 1) allow 1 dose escalation per patient; 2) shorten interval between doses from 28 days to 14 days for first 8 weeks; 3) administer the first 48 hours in hospital, and if no side effects occur continue in the outpatient department; 4) eligibility expanded to include patients whose malignancy was diagnosed before age 21. Four patients completed therapy and all had tumor progression. Three are undergoing treatment now. Significant changes in NK activity were noted in some patients. Remarkably, in contrast to canine patients in a comparable trial, no human has made antibody to TALL-104.
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