Phase I Intranodal Trial

Product: ISF35 (Active Immune Therapy)
Location: Moores Cancer Center (UCSD)
Principal Investigator: Januario E. Castro, M.D.

Status: In Progress

Memgen is conducting a Phase I intranodal trial under the direction of Januario E. Castro, M.D., at the University of California, San Diego (UCSD).

Goals

The main goal of this trial is to determine the safety and maximum tolerated dose of ISF35 when injected directly into the lymph nodes of patients who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Preclinical Studies

Preclinical studies using intra-tumoral injection of ISF35 have demonstrated safety and anti-tumoral responses of the injected product. Animals injected with ISF35 exhibited no untoward local reactions, weight loss, or other detectable, undesirable systemic effects. In addition, animals that received ISF35 had significant decreases in tumor size and increased survival compared to those who received a control substance.

Study Design

In this clinical trial, ISF35 will be injected directly into the lymph nodes of patients with CLL using a replication-defective adenovirus. After this in vivo product administration, CLL cells expressing ISF35 may activate a therapeutic immune response directed against target leukemia cells.

The ISF35 injections are performed using ultrasound guidance. This dose escalation trial consists of four cohorts of patients, with each cohort to include three to six patients. The four ISF35 doses chosen to be tested are: 1 x 10¹⁰ viral particles (vp), 3 x 10¹⁰ vp, 1 x 10¹¹ vp, and 3 x 10¹¹ vp. Beginning with the first cohort, escalation to the next dose level will be done only if no dose-limiting toxicity (DLT) is observed during the first 21 days of treatment. Dose escalation will continue to the highest dose initially planned under the protocol (3 x 10¹¹ vp) or until a DLT is encountered.

After the initial treatment period, patients will be followed and evaluated every three months for 12 months post-injection. Results of this Phase I clinical trial will be included on this site as soon as they are available.