Open-Label Extension Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered in Participants With B-cell NHL

Alopexx Oncology

Status and phase: Terminated; Phase 2; Phase 1

Conditions: B-cell Non-Hodgkin Lymphoma

Treatments: Drug: DI-Leu16-IL2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02151903

AO-101-EXT

Details and patient eligibility

About

This is an open-label extension study enrolling participants experiencing clinical benefit following 6 cycles of DI-Leu16-IL2 while enrolled in the Alopexx Oncology Dose-Escalation AO-101 study (NCT01874288). Participants will be permitted to continue to receive DI-Leu16-IL2 at the same dose, schedule, and route of administration they received during Study AO-101 (Main Study). Prior pre-treatment (for example, Rituximab) will continue as before.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants currently entered on Alopexx Oncology Study AO-101
2. Participants who received 6 cycles of DI-Leu16-IL2 on Study AO-101.
3. Documented clinical benefit following 6th cycle of DI-Leu16-IL2
4. Able to begin extension study within 8 weeks of receiving 6th cycle of DI-Leu16-IL2
5. Participants must have received prior Rituximab-containing therapy.
6. Participants in this extension study are to use adequate birth control measures (abstinence, oral contraceptives, barrier method with spermicide or surgical sterilization) during the study. Females of childbearing potential must have a negative serum pregnancy test on the days of dosing. A female of childbearing potential: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (that is, has had menses at any time in the preceding 24 consecutive months.
7. Provide written informed consent prior to any study procedures.

Exclusion criteria

1. Pregnant or lactating female
2. An immediate need for palliative radiotherapy or systemic corticosteroid therapy.
3. Actively infected with or chronic carriers of hepatitis B virus (HBV) as demonstrated by positive hepatitis B core antibody (HbcAb) or hepatitis B surface antigen (HbsAg). Participants who are sero-positive only, that is, surface antibody positive [HbsAb], are permitted.
4. Other significant active infection
5. Major surgery, chemotherapy, investigational agent, or radiation within 30 days of Day 1
6. Uncontrolled hypertension (diastolic ≥ 100 millimeters of mercury [mmHg]) or hypotension (systolic ≤ 90 mmHg)
7. History of prior therapy or a serious, uncontrolled medical disorder that in the Investigator's opinion would impair participation in the study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

DI-Leu16-IL2 1.0 mg/m^2

Experimental group

Description:

Participants will receive DI-Leu16-IL2 1.0 milligrams per square meter (mg/m\^2) subcutaneously (SC) for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects.

Treatment:

Drug: DI-Leu16-IL2

DI-Leu16-IL2 2.0 mg/m^2

Experimental group

Description:

Participants will receive DI-Leu16-IL2 2.0 mg/m\^2 SC for 3 consecutive days every 3 weeks (21-day cycle). Participants will continue to receive therapy through the duration of the study as long as they will have clinical benefit and will not experience any untoward side effects.

Treatment:

Drug: DI-Leu16-IL2