A Phase I Trial of Autologous CLL B Cells Transduced to Express Chimeric CD154 (ISF35)

NCT00779883 | Completed Phase 1 DMC

• 1 other identifier: CLL-35-101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Chronic Lymphocytic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assess the toxicity, tolerability, and safety of 1x10^8, 3x10^8, and 1x10^9 autologous Ad-ISF35-transduced CLL B cells given as a single intravenous infusion in patients with CLL.

  Duration of the trial

Secondary Outcomes (3)

• Assess the anti-leukemia activity of a single intravenous dose by evaluating reduction in leukemia count, reduction in adenopathy and splenomegaly, and improvement in bone function.

  Duration of the trial

• Assess the quality of life with ISF35 treatment.

  Two months

• Assess pharmacodynamic endpoints including induction of T cell anti-leukemia immune responses, antibody production against autologous CLL B cells, and changes in bystander leukemia cell phenotype.

  Two months

Interventions

ISF35 BIOLOGICAL

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.

Also known as: Ad-ISF35, AdISF35

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subjects must be age 18 years or older.
• 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.
• Subjects must have Zubrod performance status of ≤ 2 (Appendix B).
• Subjects must have adequate hematologic, renal, hepatic, and coagulation function:
• Adequate hematologic function:

You may not qualify if:

• Presence of more than 55% prolymphocytes.
• 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.
• Ongoing toxicity from prior anti-neoplastic therapy.
• Prior gene therapy or allogeneic stem cell transplantation.
• Untreated autoimmune hemolytic anemia or immune thrombocytopenia.
• Active infection requiring parenteral antibiotics.
• Known HIV/HBV/HCV seropositivity.
• Uncompensated hypothyroidism (defined as TSH greater than 4x upper limit of normal not treated with replacement hormone).

Sponsors & Collaborators

• Memgen, LLC: lead

Study Sites (1)

University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (53)

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MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia; Leukemia, B-Cell; Immune System Diseases

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• William G. Wierda, M.D., Ph.D.

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: October 24, 2008
• Study Start: June 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: October 24, 2008

Record last verified: 2008-10

Locations

US (1)