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Immunomodulatory Agent

Q702 for Blood Cancer

Phase 1

Waitlist Available

Led By Jithma P. Abeykoon, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

Must not have

Concomitant use of any herbal supplements

MPN patients with known active CNS metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called Q702 in patients with blood cancers. Q702 helps the immune system kill cancer cells and produce normal blood cells. The trial aims to find the safest and most

Who is the study for?

This trial is for patients with various blood-related cancers like lymphoma and leukemia. Participants should have a type of cancer that hasn't responded to standard treatments or has come back. They'll undergo tests like bone marrow biopsies, CT scans, MRIs, and PET scans to monitor their response.

What is being tested?

The trial is testing Q702's safety and the best dose to use. Q702 is an immunomodulatory agent—it boosts the immune system to fight cancer cells and helps produce healthy blood cells in the bone marrow.

What are the potential side effects?

Potential side effects of Q702 may include reactions at the injection site, flu-like symptoms, fatigue, fever, chills, nausea, or changes in blood pressure. The exact side effects will be studied as part of this trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can take care of myself and am up and about more than 50% of my waking hours.

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My disease can be measured or assessed with tests.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not taking any herbal supplements.

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I have brain metastases or carcinomatous meningitis from my MPN.

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I am not taking any drugs that affect liver enzyme activity.

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I do not have an active infection with any specific viruses.

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I do not have another cancer that needs treatment interfering with this study.

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I am not pregnant, breastfeeding, or if capable of becoming pregnant, I am using effective birth control.

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I have recently used specific therapies as my main cancer treatment.

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I do not have any ongoing serious infections needing treatment.

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I have not had serious heart issues or surgeries in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years 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 dose limiting toxicity

Overall response rate

Secondary study objectives

Incidence of adverse events

Overall survival (OS)

Progression free survival (PFS)

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 (Q702)Experimental Treatment8 Interventions

Patients receive Q702 PO QD on days 1-7 and 15-21 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 6 cycles, patients who have not progressed/relapsed may continue on therapy at their current dose at MD/patient discretion for an additional 6 cycles. Patients undergo blood and urine sample collection and may undergo PET scan/CT scan or MRI and bone marrow aspiration and biopsy throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Magnetic Resonance Imaging

2017

Completed Phase 3

~1180