An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Anti-KIR (1-7F9) in Subjects With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring multiple myeloma, Anti-KIR (1-7F9)
Eligibility Criteria
Inclusion Criteria:
- Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
- Bone marrow plasmacytosis > 10% (as determined by bone marrow aspirate) or plasmacytoma
- Relapse or progression after at least one prior systemic treatment regimen for Multiple Myeloma (MM) as evidenced by ≥ 25% increase in the M-protein as compared to the best response from the previous treatment regimen.
3a. One prior therapy for multiple myeloma, Measurable disease, as defined by persistent presence of serum and/or urine monoclonal protein or abnormal serum free light chain ratio following the prior treatment.
a. Only for the last seven patients enrolled into the cohort 7 or Maximal Tolerated Dose (MTD).
4. Full recovery from acute toxicities of prior anti-MM therapies. 5. Peripheral blood (Natural Killer) NK cells (Absolute CD16, 56)≥ 0.05 x 109/L (50/mm3) 6. Detectable binding of Anti-KIR (1-7F9) to subject NK cells 7. Age ≥ 18 years 8. Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 9. Clinical laboratory values at screening:
- serum creatinine < grade 2 toxicity i.e. 1.5x upper limit of institutional normal value
- total bilirubin < 1.5x upper limit of institutional normal value
- Aspartate aminotransferase (AST) < or = 3x upper limit of institutional normal value
- Absolute Neutrophil Count (ANC) >1.2 x109/L
- Platelets >70x109/L
Exclusion Criteria:
- Known or suspected allergy to trial product or related products
- Previous participation in this trial (dosed)
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (appropriate methods include abstinence and the following methods: diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives)
- Male subjects who are sexually active and have not been surgically sterilized must be informed that they must either use a condom during intercourse, ensure that their partners practices contraception, or they must refrain from sexual intercourse during the study and until 1 month after completion of the trial.
- Use of an investigational agent within 30 days of the first dose of study drug (or five half-lives of any antibody).
- Current treatment with any other anti-MM therapy excluding prophylactic bisphosphonates.
- Radiotherapy against bone lesions within 4 weeks or visceral lesions within 8 weeks of Screening.
- Thalidomide or bortezomib treatment within 14 days of Screening.
- Cytotoxic chemotherapy (excluding thalidomide or bortezomib) or corticosteroid treatment within 28 days of Screening.
- Subjects with non-secretory multiple myeloma
- Subjects on dialysis
- Use of myeloid growth factor within 28 days of screening
- G-CSF treatment within 28 days of screening
- Active autoimmune disease
- Active infectious disease (e.g. HIV, chronic hepatitis, etc.) as judged by the investigator.
- New York Heart Association (NYHA) class III-IV heart failure
- Severe neurological / psychiatric disorder as judged by the investigator
- Clinical evidence of an active second malignancy, with the exception of basal cell carcinoma or in situ carcinoma of cervix.
- Subjects with a history of allogenic transplantation.
- Subject who have undergone autologous transplantation within the last 3 months.
- Mental incapacity or inadequate understanding of English.
- Any serious medical condition that in the opinion of the investigator, disqualifies the subject for inclusion in the trial.
Sites / Locations
- Indiana University Cancer Center
- Mont Sinai Medical Center
- Ohio State University Medical Center
- Cancer Therapy Research Center at UTHSCSA