Anti-ICOS Monoclonal Antibody for Peripheral T-cell Lymphoma

Recruiting at 22 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

21 Participants Needed

Trial Summary

What is the purpose of this trial?

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 with peripheral T-cell lymphoma follicular variant or angioimmunoblastic T-cell lymphoma that has returned after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread.

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 the anti-ICOS monoclonal antibody safe for humans?

The anti-ICOS monoclonal antibody has been studied for its effects on the immune system, particularly in reducing complications like graft-versus-host disease (a condition where donor cells attack the recipient's body) in animal models. While these studies suggest potential therapeutic benefits, they do not provide detailed safety data for humans, so more research is needed to fully understand its safety profile. ^{1 2 3 4 5}

What makes the drug MEDI-570 unique for treating peripheral T-cell lymphoma?

MEDI-570 is an anti-ICOS monoclonal antibody, which means it targets a specific protein on T-cells involved in immune response, potentially offering a novel approach compared to traditional chemotherapy that targets rapidly dividing cells in general. ^{6 7 8 9 10}

Research Team

Julio C Chavez

Principal Investigator

University Health Network Princess Margaret Cancer Center LAO

Eligibility Criteria

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

For dose expansion/dose confirmation phase:

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

Exclusion Criteria

My condition is listed as eligible for the trial.

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

I haven't had serious infections like TB or severe herpes in the last 6 months.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

An agonist human ICOS monoclonal antibody that induces T cell activation and inhibits proliferation of a myeloma cell line. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Targeting of inducible costimulator (ICOS) expressed on alloreactive T cells down-regulates graft-versus-host disease (GVHD) and facilitates engraftment of allogeneic bone marrow (BM). [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

ICOS: a new costimulatory ligand/receptor pair and its role in T-cell activion. [2011]

4. England pubmed.ncbi.nlm.nih.gov

The rationale behind targeting the ICOS-ICOS ligand costimulatory pathway in cancer immunotherapy. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Induction, binding specificity and function of human ICOS. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Marker expression in peripheral T-cell lymphoma: a proposed clinical-pathologic prognostic score. [2017]

7. United States pubmed.ncbi.nlm.nih.gov

New molecular insights into peripheral T cell lymphomas. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Oligoclonal populations of T and B cells in a case of angioimmunoblastic T-cell lymphoma predominantly infiltrated by T cells of the VB5.1 family. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Characterization of a new mouse model for peripheral T cell lymphoma in humans. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Expression of follicular helper T cell markers in nodal peripheral T cell lymphomas: a tissue microarray analysis of 162 cases. [2019]