A Phase I Trial of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35)
NCT ID: NCT00779883
Last Updated: 2008-10-24
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
9 participants
Study Classification
INTERVENTIONAL
Study Start Date
2006-06-30
Study Completion Date
2008-03-31
Brief Summary
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The study is a Phase I, dose-escalating, non-randomized, single institution clinical trial assessing the safety and efficacy of autologous Ad-ISF35-transduced CLL B cells administered as a single intravenous infusion in patients with chronic lymphocytic leukemia (CLL).
Detailed Description
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Memgen's first TNF family derived product, ISF35, is a gene that encodes a recombinant protein molecule that binds and activates human CD40+ B lymphocytes that are found on a vast majority of malignant leukemias and lymphomas.
In this clinical trial, ISF35 will be introduced into the patients' CLL cells ex vivo using a replication-defective adenovirus Ad5 encoding the ISF35 cDNA transgene. After this ex vivo manipulation, the modified leukemia cells will be extensively washed and the amount of remaining free virus is measured before the cells are reinfused into the patient. Following ex vivo transduction, the CLL cells expressing ISF35 activate a therapeutic immune response directed against the target leukemia cells.
This ascending-dose trial will be divided into three dosing cohorts to determine the existence of a maximum tolerated dose.
Patients will be followed for 12 months after ISF35 administration or until initiation of another treatment.
In this clinical trial, ISF35 will be introduced into the patients' CLL cells ex vivo using a replication-defective adenovirus Ad5 encoding the ISF35 cDNA transgene. After this ex vivo manipulation, the modified leukemia cells will be extensively washed and the amount of remaining free virus is measured before the cells are reinfused into the patient. Following ex vivo transduction, the CLL cells expressing ISF35 activate a therapeutic immune response directed against the target leukemia cells.
This ascending-dose trial will be divided into three dosing cohorts to determine the existence of a maximum tolerated dose.
Patients will be followed for 12 months after ISF35 administration or until initiation of another treatment.
Conditions
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Chronic Lymphocytic Leukemia
Keywords
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Chronic lymphocytic leukemia
CLL
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Immune System Diseases
ISF35
Ad-ISF35
Immunotherapy
Immune therapy
Active immune therapy
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Interventions
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ISF35
Subjects participating in this study will receive a single dose of 1x10\^8, 3x10\^8, or 1x10\^9 autologous Ad-ISF35-transduced CLL B cells.
Intervention Type
BIOLOGICAL
Other Intervention Names
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Ad-ISF35
AdISF35
Eligibility Criteria
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Inclusion Criteria
1. Subjects must have a diagnosis of B cell CLL, measurable disease, and an
NCI-WG indication for treatment with one of the following:
* Massive (\>6 cm below left costal margin) or progressive splenomegaly;
* Massive (\>10 cm longest diameter) lymph nodes, nodal clusters, or progressive lymphadenopathy;
* Progressive anemia;
* Progressive thrombocytopenia;
* Weight loss \> 10% body weight over the preceding 6 month period;
* Fatigue attributable to CLL;
* Fever or night sweats without evidence of infection;
* Progressive lymphocytosis.
2. Subjects must be age 18 years or older.
3. Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women participants must agree to use contraception for the duration of the study.
4. Subjects must have Zubrod performance status of ≤ 2 (Appendix B).
5. Subjects must have adequate hematologic, renal, hepatic, and coagulation function:
* Adequate hematologic function:
* Platelet count ≥ 50,000/μl; AND
* Hemoglobin ≥ 10 g/dl (may be supported by erythropoietin or transfusion).
* Adequate renal function:
* Serum creatinine ≤ 1.5 times upper limit of normal; OR
* Measured creatinine clearance ≥ 40 mL/min/1.73 m\^2.
* Adequate hepatic function:
* Total bilirubin ≤ 2.5 times upper limit of normal; AND
* ALT ≤ 2.5 times upper limit of normal; AND
* Adequate coagulation tests:
* Prothrombin time international normalized ratio (INR) ≤ 2; AND
* Partial thromboplastin time ≤ 1.66 times upper limit of normal
6. Subjects must be able to give written informed consent.
NCI-WG indication for treatment with one of the following:
* Massive (\>6 cm below left costal margin) or progressive splenomegaly;
* Massive (\>10 cm longest diameter) lymph nodes, nodal clusters, or progressive lymphadenopathy;
* Progressive anemia;
* Progressive thrombocytopenia;
* Weight loss \> 10% body weight over the preceding 6 month period;
* Fatigue attributable to CLL;
* Fever or night sweats without evidence of infection;
* Progressive lymphocytosis.
2. Subjects must be age 18 years or older.
3. Women of childbearing potential (not postmenopausal for at least one year or not surgically incapable of bearing children) must agree not to become pregnant for the duration of the study. Both men and women participants must agree to use contraception for the duration of the study.
4. Subjects must have Zubrod performance status of ≤ 2 (Appendix B).
5. Subjects must have adequate hematologic, renal, hepatic, and coagulation function:
* Adequate hematologic function:
* Platelet count ≥ 50,000/μl; AND
* Hemoglobin ≥ 10 g/dl (may be supported by erythropoietin or transfusion).
* Adequate renal function:
* Serum creatinine ≤ 1.5 times upper limit of normal; OR
* Measured creatinine clearance ≥ 40 mL/min/1.73 m\^2.
* Adequate hepatic function:
* Total bilirubin ≤ 2.5 times upper limit of normal; AND
* ALT ≤ 2.5 times upper limit of normal; AND
* Adequate coagulation tests:
* Prothrombin time international normalized ratio (INR) ≤ 2; AND
* Partial thromboplastin time ≤ 1.66 times upper limit of normal
6. Subjects must be able to give written informed consent.
Exclusion Criteria
1. Presence of more than 55% prolymphocytes.
2. Chemotherapy (e.g., purine analogues, alkylating agents, or corticosteroids), antibody therapy, immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of enrollment into protocol or at any time during the study.
3. Ongoing toxicity from prior anti-neoplastic therapy.
4. Prior gene therapy or allogeneic stem cell transplantation.
5. Untreated autoimmune hemolytic anemia or immune thrombocytopenia.
6. Active infection requiring parenteral antibiotics.
7. Known HIV/HBV/HCV seropositivity.
8. Uncompensated hypothyroidism (defined as TSH greater than 4x upper limit of normal not treated with replacement hormone).
2. Chemotherapy (e.g., purine analogues, alkylating agents, or corticosteroids), antibody therapy, immunotherapy, radiation therapy, or participation in any investigational drug treatment within 4 weeks of enrollment into protocol or at any time during the study.
3. Ongoing toxicity from prior anti-neoplastic therapy.
4. Prior gene therapy or allogeneic stem cell transplantation.
5. Untreated autoimmune hemolytic anemia or immune thrombocytopenia.
6. Active infection requiring parenteral antibiotics.
7. Known HIV/HBV/HCV seropositivity.
8. Uncompensated hypothyroidism (defined as TSH greater than 4x upper limit of normal not treated with replacement hormone).
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Memgen, LLC
INDUSTRY
Sponsor Role
lead
Responsible Party
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M.D. Anderson Cancer Center
Principal Investigators
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William G. Wierda, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Site Status
Countries
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United States
References
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RESULT
Other Identifiers
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CLL-35-101
Identifier Type: -
Identifier Source: org_study_id