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| Sponsor: | Innate Pharma |
|---|---|
| Information provided by: | Innate Pharma |
| ClinicalTrials.gov Identifier: | NCT00552396 |
Purpose
Development of new treatments for diseases such as multiple myeloma is a focus for research. The research being conducted is on treatment called Anti-KIR (1-7F9), which activates the body's own cells to kill tumor cells. This is different from many other treatments where chemicals are given to kill tumor cells. The purpose of the study is to determine a safe dose of Anti-KIR (1-7F9) to administer in humans and to gain information about its effectiveness in the treatment of multiple myeloma.
| Condition | Intervention | Phase |
|---|---|---|
|
Refractory Multiple Myeloma |
Drug: Anti-KIR (1-7F9) |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Dose-escalation Safety and Tolerability Trial Assessing Multiple Dose Administrations of Anti-KIR (1-7F9) Human Monoclonal Antibody in Subjects With Multiple Myeloma |
| Enrollment: | 32 |
| Study Start Date: | May 2007 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Trial Design:
The trial is an open-label, dose-escalation trial to determine the safety and tolerability of Anti-KIR (1-7F9) in subjects with relapsed or refractory multiple myeloma. A 3+3 design will be employed for the first dosing cycle at each dose level. The 7 planned dose levels are 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg and 3.0 mg/kg. The subjects will receive up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks. Safety, toxicity, PK and PD obtained in the first 4 weeks after dosing per group will be the basis for dose-escalation decisions. There will be follow-up visits every week the one month after the first administration and every two weeks following the second, third and fourth administrations. After the last administration there will be follow-up visits every month until KIR occupancy is no longer detected.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 MTD. 4. Full recovery from acute toxicities of prior anti-MM therapies. 5. Peripheral blood 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:
Exclusion Criteria:
Contacts and Locations| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New York | |
| Mont Sinai Medical Center | |
| New York City, New York, United States, 10029 | |
| United States, Ohio | |
| Ohio State University Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| Cancer Therapy Research Center at UTHSCSA | |
| San Antonio, Texas, United States, 78229-4427 | |
| Principal Investigator: | Sherif Farag, MD, PhD | Indiana University |
| Principal Investigator: | Don Benson, Jr., MD, PhD | Division of Haematology/Oncology - Ohio State University |
| Principal Investigator: | Swaminathan Padmanabhan, MD | CTRC Institute for Drug Development - University of Texas at San Antonio |
| Principal Investigator: | Sundar Jagannath, MD | Mount Sinai Hospital, New York |
More Information
| Responsible Party: | Renaud Buffet, MD/Senior Director, Clinical Development and Translational Research, Innate Pharma |
| ClinicalTrials.gov Identifier: | NCT00552396 History of Changes |
| Other Study ID Numbers: | IPH2101-103 |
| Study First Received: | May 21, 2007 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
refractory multiple myeloma Anti-KIR (1-7F9 |
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders |
Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |