Q702 for the Treatment of Patients With Hematologic Malignancies

NCT06712810 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: MC220806NCI-2024-0956324-004752
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

This phase I trial tests the safety, side effects, and best dose of Q702 in treating patients with hematologic malignancies. Q702 is in a class of medications called immunomodulatory agents. It works by helping the immune system kill cancer cells and by helping the bone marrow to produce normal blood cells. Giving Q702 may be safe, tolerable and/or effective in treating patients with hematologic malignancies.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Histiocytic Sarcoma; Malignant Histiocytosis; Peripheral T-Cell Lymphoma, Not Otherwise Specified; Primary Cutaneous T-Cell Non-Hodgkin Lymphoma; Recurrent Chronic Lymphocytic Leukemia; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Follicular Lymphoma; Recurrent Langerhans Cell Histiocytosis; Recurrent Lymphoplasmacytic Lymphoma; Recurrent Myelodysplastic Syndrome; Recurrent Myelofibrosis; Recurrent Small Lymphocytic Lymphoma; Recurrent Waldenstrom Macroglobulinemia; Refractory Chronic Lymphocytic Leukemia; Refractory Chronic Myelomonocytic Leukemia; Refractory Erdheim-Chester Disease; Refractory Follicular Lymphoma; Refractory Langerhans Cell Histiocytosis; Refractory Lymphoplasmacytic Lymphoma; Refractory Myelodysplastic Syndrome; Refractory Myelofibrosis; Refractory Small Lymphocytic Lymphoma; Refractory Waldenstrom Macroglobulinemia; Rosai-Dorfman-Destombes Disease; Primary Central Nervous System Lymphoma; Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm; Recurrent Erdheim-Chester Disease; Recurrent Fibroblastic Reticular Cell Sarcoma; Recurrent Histiocytic Sarcoma; Recurrent Interdigitating Dendritic Cell Sarcoma; Recurrent Rosai-Dorfman-Destombes Disease; Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm; Refractory Fibroblastic Reticular Cell Sarcoma; Refractory Histiocytic Sarcoma; Refractory Interdigitating Dendritic Cell Sarcoma; Refractory Rosai-Dorfman-Destombes Disease

Outcome Measures

Primary Outcomes (2)

• Incidence of dose limiting toxicity

  Up to completion of the first cycle (cycle length= 28 days)

  Up to 3 years

• Overall response rate

  Exact binomial 95% confidence intervals for the true rate of overall response will be calculated.

  Up to 3 years

Secondary Outcomes (3)

• Progression free survival (PFS)

  Up to 3 years

• Overall survival (OS)

  Up to 3 years

• Incidence of adverse events

  Up to 3 years

Study Arms (1)

Treatment (Q702)

EXPERIMENTAL

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.

Drug: Axl/Mer/CSF1R Inhibitor Q702; Procedure: Biospecimen Collection; Procedure: Bone Marrow Aspiration; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Survey Administration

Interventions

Axl/Mer/CSF1R Inhibitor Q702 DRUG

Given PO

Also known as: Axl/Mer/CSF1R Selective Tyrosine Kinase Inhibitor Q702, Q 702, Q-702, Q702, RTK Inhibitor Q702

Treatment (Q702)

Biospecimen Collection PROCEDURE

Undergo blood and urine sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (Q702)

Bone Marrow Aspiration PROCEDURE

Undergo bone marrow biopsy and aspiration

Treatment (Q702)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy and aspiration

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (Q702)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Treatment (Q702)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Treatment (Q702)

Positron Emission Tomography PROCEDURE

Undergo PET scan

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (Q702)

Survey Administration OTHER

Ancillary study

Treatment (Q702)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PRE-REGISTRATION: Age ≥ 18 years
• PRE-REGISTRATION: Not eligible for or have failed therapies with established benefits, at the discretion of the treating physician
• PRE-REGISTRATION: Patients must meet one of the following criteria:
• Relapsed/refractory patients with Erdheim-Chester disease, Langerhans histiocytosis, histiocytic sarcoma, or other malignant histiocytosis without activating alterations in v-Raf murine sarcoma viral oncogene homolog B (BRAF) or Mitogen-activated protein kinase kinase (MAP2K) oncogenes who have progressed after first line of therapy.
• Note: Relapsed is defined as a relapse that occurred after having a response to the last therapy at any point during the treatment. Refractory is no response (stable disease or progressive disease while on therapy) to a given treatment at least after 1 month of being on the given treatment.
• Newly diagnosed patients with Rosai-Dorfman disease without activating alterations in MAP2K oncogenes.
• Relapsed/refractory patients with Rosai-Dorfman disease and an activating mitogen-activated protein kinase (MAPK) pathway alteration who have failed prior treatment with cobimetinib.
• Relapsed/refractory patients with Erdheim-Chester disease or Langerhans histiocytosis who have received vemurafenib for BRAF V600E mutated disease or cobimetinib for disease with activating MAP2K alterations.
• Patients with Erdheim-Chester disease, Rosai-Dorfman disease, Langerhans histiocytosis, histiocytic sarcoma, or another malignant histiocytosis who cannot tolerate or have a contraindication to BRAF or MEK inhibitors or those who cannot have reliable access to these inhibitors due to financial restraints or geographic location or initiation of BRAF or mitogen-activated protein kinase kinase (MEK) inhibitors is futile based on the genomic alterations or the discretion of treating physician.
• Relapsed/refractory higher risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) or myelofibrosis (MF).
• Note: MF patients must have failed ≥ 1 of the 4 Food and Drug Administration (FDA)-approved Janus kinase (JAK) Inhibitors for MF (i.e. ruxolitinib, fedratinib, pacritinib, momelotinib) to be eligible. MDS and CMML patients must have failed hypomethylating agent-based therapy, if eligible.
• Note: Higher risk is defined as intermediate or higher risk by international prognostic scoring system (IPSS-R) or moderate high or higher risk as per molecular internal prognostic scoring system (IPSS-M).
• T cell lymphoma (peripheral and cutaneous), or mantle cell lymphomas. Patients must have failed ≥ 2 lines of therapy.
• Primary central nervous system (CNS) lymphoma who has failed ≥ 2 lines of therapy.
• Relapsed or refractory follicular lymphoma; or Waldenstrom macroglobulinemia/lymphoplasmacytic lymphoma. Must have failed ≥ 2 lines of therapy.

You may not qualify if:

• PRE-REGISTRATION: Myeloproliferative neoplasm (MPN) patients with known active CNS metastases and/or carcinomatous meningitis.
• Note: Histiocytosis and lymphoma patients who are on steroids are allowed to enroll
• REGISTRATION: Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effect on the developing fetus and newborn are unknown:
• Pregnant persons
• Nursing persons
• Persons of childbearing potential (and persons able to father a child) who are unwilling to employ adequate contraception
• REGISTRATION: New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure ≤ 6 months prior to registration
• REGISTRATION: Corrected QT interval (using Fridericia's correction formula) (QTcF) of \> 470 msec
• REGISTRATION: Known active infection with human immunodeficiency virus (HIV), Human T-lymphotropic virus 1 (HTLV-1), hepatitis B virus (HBV), or hepatitis C virus (HCV):
• Active infection with (HIV) and CD4+ T-cell count \< 350 μL.
• Patients with a detectable HIV viral load and not on antiretroviral therapy (ART) for ≥ 4 weeks.
• Exceptions:
• Patients with a history of hepatitis B or C are allowed if HBV deoxyribonucleic acid (DNA) or HCV ribonucleic acid (RNA) are undetectable.
• Patients with active HIV infection and CD4+ T-cell count ≥ 350 μL who are on active antiretroviral treatment
• REGISTRATION: Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Histiocytic Sarcoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelomonocytic, Chronic; Lymphoma, Follicular; Histiocytosis, Langerhans-Cell; Lymphoma, B-Cell, Marginal Zone; Myelodysplastic Syndromes; Primary Myelofibrosis; Waldenstrom Macroglobulinemia; Erdheim-Chester Disease; Blastic Plasmacytoid Dendritic Cell Neoplasm; Dendritic Cell Sarcoma, Interdigitating

Interventions

Specimen Handling; Biopsy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Histiocytic Disorders, Malignant; Neoplasms by Histologic Type; Neoplasms; Histiocytosis; Lymphatic Diseases; Hemic and Lymphatic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Myelodysplastic-Myeloproliferative Diseases; Bone Marrow Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Lymphoma, B-Cell; Myeloproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Histiocytosis, Non-Langerhans-Cell; Hematologic Neoplasms; Neoplasms by Site; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Jithma P. Abeykoon, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 2, 2024
• Study Start: August 27, 2025
• Primary Completion (Estimated): September 15, 2030
• Study Completion (Estimated): September 15, 2030
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)