Anti-ICOS Monoclonal Antibody for Peripheral T-cell Lymphoma

Not currently recruiting at 27 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: National Cancer Institute (NCI)

Must not be taking: Investigational agents, Live vaccines

Disqualifiers: Brain metastases, Active infection, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: Up to 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the optimal dose and observe any side effects of a new immunotherapy treatment, MEDI-570, for patients with specific types of T-cell lymphoma. These cancers affect the immune system and include peripheral T-cell lymphoma and angioimmunoblastic T-cell lymphoma, particularly if they have recurred or not responded to previous treatments. The trial targets participants with one of these lymphomas who have not found success with other treatments. Participants will receive MEDI-570 through an IV every 21 days, up to eight times, as long as the treatment remains effective and safe. As a Phase 1 trial, this research focuses on understanding how MEDI-570 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be at least 14 days from your last therapy dose or 5 half-lives, whichever is shorter, before starting the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that MEDI-570, an anti-ICOS monoclonal antibody, was generally well tolerated in past studies. Patients with angioimmunoblastic T-cell lymphoma (AITL) showed promising results. Specifically, the studies found that MEDI-570 was safe and helped reduce ICOS+ T lymphocytes, potentially inhibiting tumor growth. Importantly, no unexpected or severe side effects were reported. While more research is needed, these early findings provide a positive outlook on the safety of MEDI-570 for prospective trial participants. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for peripheral T-cell lymphoma typically involve chemotherapy, radiation, or targeted therapies like pralatrexate and brentuximab vedotin, which focus on different cellular targets. However, MEDI-570 stands out because it targets the ICOS (Inducible T-cell CO-Stimulator) pathway, which is a novel approach in this context. By specifically inhibiting this pathway, MEDI-570 aims to modulate the immune response more precisely, potentially leading to fewer side effects and enhanced effectiveness. Researchers are excited about this treatment because it represents a new mechanism of action that might offer better outcomes for patients who do not respond well to existing therapies.

What evidence suggests that MEDI-570 might be an effective treatment for peripheral T-cell lymphoma?

Research has shown that the drug MEDI-570, a type of antibody, may help treat certain T-cell lymphomas, such as angioimmunoblastic T-cell lymphoma (AITL). In this trial, participants will receive MEDI-570 as the investigational treatment. Studies have found that patients generally tolerated MEDI-570 well, and it showed promise, especially for those who did not respond to other treatments. MEDI-570 targets and reduces specific T-cells that may aid cancer growth, aiming to stop the cancer from spreading. Overall, early results are encouraging, suggesting that MEDI-570 could effectively treat these challenging lymphomas. ^{1 2 3 6 7}

Who Is on the Research Team?

Julio C Chavez

Principal Investigator

University Health Network Princess Margaret Cancer Center LAO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

- The effects of MEDI-570 on the developing human fetus are unknown; for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for 3 months after the last dose of the drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must have either had a prior vasectomy or agree to use effective contraception prior to the study, during the study, and for 3 months after the last dose of the drug; males should avoid fathering children during and for at least three months after therapy is completed

My condition worsened or didn't improve after a stem cell transplant.

For dose expansion/dose confirmation phase:

Exclusion Criteria

My condition is listed as eligible for the trial.

You have a history of a weakened immune system from birth.

If you have asthma or mild seasonal allergies that are well-controlled, you can still participate.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive anti-ICOS monoclonal antibody MEDI-570 intravenously 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.

Up to 24 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Every 6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MEDI-570

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment (MEDI-570) Experimental Treatment 3 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.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02520791

Anti-ICOS Monoclonal Antibody MEDI-570 in Treating ... This phase I trial studies the side effects and best dose of anti-inducible T-cell co-stimulator (ICOS) monoclonal antibody MEDI-570 in treating patients ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36826995/

Targeting the Inducible T-cell Costimulator (ICOS) in Patients ... MEDI-570 was well tolerated and showed promising clinical activity in refractory AITL. MEDI-570 resulted in sustained reduction of ICOS+ T lymphocytes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118703789

A Phase I Study of Anti-ICOS Antibody MEDI-570 for ... MEDI-570 was safe, well tolerated and showed promising clinical activity in poor-risk refractory and heavily pretreated AITL.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10716864/

Targeting the Inducible T-cell Costimulator (ICOS) in ... The current study NCI-9930 was conducted to evaluate the safety and preliminary efficacy of MEDI-570 in T-cell NHL, particularly AITL and TFH-PTCL as they are ...

5. researchgate.net researchgate.net/publication/346664705_A_Phase_I_Study_of_Anti-ICOS_Antibody_MEDI-570_for_RelapsedRefractory_RR_Peripheral_T-Cell_Lymphoma_PTCL_and_Angioimmunoblastic_T-Cell_Lymphoma_AITL_NCI-9930

A Phase I Study of Anti-ICOS Antibody MEDI-570 for ... We investigate the safety, pharmacokinetics (PK) and clinical activity of ICOS blockade by MEDI-570 in T-cell lymphomas. ... peripheral T-cell lymphoma (PTCL).

6. onclive.com onclive.com/view/anti-icos-antibody-medi-570-elicits-durable-responses-in-relapsed-refractory-t-cell-lymphomas

Anti-ICOS Antibody MEDI-570 Elicits Durable Responses ... The anti-inducible T-cell co-stimulator monoclonal antibody MEDI-570 showed clinical activity with durable responses, as well as acceptable ...

7. aacrjournals.org aacrjournals.org/clincancerres/article/29/10/1869/726254/Targeting-the-Inducible-T-cell-Costimulator-ICOS

Targeting the Inducible T-cell Costimulator (ICOS) in Patients ... In this study, we demonstrated for the first time the clinical activity of MEDI-570, and anti-ICOS IgG4 monoclonal antibody, in TFH lymphomas, specifically AITL ...