Anti-ICOS Monoclonal Antibody for Peripheral T-cell Lymphoma

Phase 1

Waitlist Available

Led By Julio C Chavez

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a monoclonal antibody that may help the body's immune system fight cancer cells in patients with relapsed or refractory T-cell lymphoma.

Who is the study for?

This trial is for patients with certain types of T-cell lymphoma that have not improved or returned after treatment. Eligible participants must have a specific diagnosis, acceptable organ function tests, measurable disease, and an ECOG performance status of 2 or less. They should not be pregnant or breastfeeding and must agree to use contraception. People with severe allergies to similar drugs, active infections like tuberculosis, recent major surgery, uncontrolled illnesses, HIV infection or those who've had certain vaccines recently cannot join.

What is being tested?

The trial is testing the safety and optimal dosage of MEDI-570 in patients with relapsed/refractory peripheral T-cell lymphoma follicular variant or angioimmunoblastic T-cell lymphoma. MEDI-570 is a monoclonal antibody designed to modify the immune system's response and potentially inhibit tumor growth.

What are the potential side effects?

Possible side effects include reactions related to the immune system such as inflammation in various organs which could lead to symptoms affecting different parts of the body depending on which organs are involved. Specific side effects will be monitored due to MEDI-570's novel action on the immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle

This trial's timeline: 3 weeks for screening, Varies for treatment, and prior to dose on day 1, immediately after dose, and at 6 minutes, 24, 48 and 72 hours post dose of cycle 1 and cycle 2, and then on day 1 pre-dose of every subsequent cycle for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of toxicity and safety of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570

Maximum tolerated dose (MTD) of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570

Recommended phase 2 dose of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570

Secondary study objectives

Immunogenicity

Overall response rate

Overall survival (OS)

+2 more

Other study objectives

Biomarkers of response and resistance to anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (MEDI-570)Experimental Treatment3 Interventions

Patients receive anti-ICOS monoclonal antibody MEDI-570 IV over 1-4 hours on day 1. Treatment repeats every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity.

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