Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma

Recruiting now · Phase 1

Conditions studied: Non-Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Refractory, Non-Hodgkin Lymphoma, Relapsed, Non Hodgkin Lymphoma, Hodgkin Lymphoma, Hodgkin Lymphoma, Adult, Hodgkin's Lymphoma, Relapsed, Adult

In brief

This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10\^6 cells (flat dosing).

Key facts

Study ID

NCT05798897

Run by

Marker Therapeutics, Inc.

People needed

79

Starts

2023-01-02

Expected to finish

2028-02-28

Last updated by the study team

2025-08-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All applicable inclusion and exclusion criteria must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment).
• Participants are eligible to be included in the study only if all of the following criteria apply and the participant, in the judgement of the Investigator, is an appropriate candidate for experimental therapy:
• General:
• Participant must be ≥ 18 years of age and capable of giving signed informed consent (ICF), which includes compliance with the requirements and restrictions listed in the ICF and in the protocol, at the time of signing the ICF.
• Disease Specific:
• Cytologically or histologically confirmed diagnosis of NHL, HL or CLL based on the 2022 World Health Organization (WHO) criteria for hematolymphoid neoplasms
• Enrollment of the following subtypes will be eligible:
• LBCL including diffuse large B cell lymphoma, primary mediastinal B cell lymphoma (PMBCL), high grade B cell lymphoma (HGBL), T cell rich B cell lymphoma and transformed indolent lymphoma (transformed iNHL)
• FL
• MCL
• MZL
• HL
• The following additional subtypes may be enrolled in disease specific cohorts during Dose Expansion (upon approval by Sponsor)
• CLL/SLL
• CNS lymphoma
• CAR T cell refractory
• Must have measurable disease as per 2014 Lugano criteria or 2018 iwCLL criteria. Participants with splenic MZL must have measurable splenomegaly on imaging or evidence of bone marrow involvement.
• Prior Treatments
• Participants who are R/R, are intolerant to, or are considered ineligible for systemic standard of care anticancer treatments, including at least 2 prior therapies. Participants who refuse standard of care treatments may also be considered if documentation is provided that he/she has been made aware of all therapeutic options.
• For participants with LBCL, FL, and MCL: Have received CD19-directed CAR T cell therapy and relapsed ≥ 30 days or attained an incomplete response as the best response within 1 year after CAR T cell administration. Participants who refuse or are ineligible for CAR T cell therapy are eligible for this study. Note: during Dose Expansion, a specific cohort may be enrolled to evaluate participants who were refractory to CD19-directed CAR T cell therapy.
• Health Status
• Karnofsky score of ≥70 or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
• Life expectancy ≥12 weeks
• Adequate blood, liver, renal and cardiac function:
• Hematology: Hemoglobin ≥ 7.0 g/dL (can be transfused), absolute lymphocyte count (ALC) ≥ 300/μL, (prior to apheresis only), absolute neutrophil count (ANC) ≥ 750/μL and platelet count ≥ 50,000/μL (prior to the conditioning regimen only)

You may not qualify if…

• Patients are excluded from the study if any of the following criteria apply:
• Disease-related
• Evidence of bulky disease at the time of the conditioning regimen (≥ 10 cm in diameter for LBCL or HL and > 6 cm for other subtypes)
• Untreated or ongoing treatment for CNS lymphoma or completed treatment within 2 weeks of apheresis (Note: May be allowed in Dose Expansion if disease specific cohort for CNS lymphoma is opened)
• Refractory to CAR T therapy defined as a best response of stable disease or disease progression (Note: May be allowed in Dose Expansion if disease specific cohort for CAR T cell therapy refractory is opened)
• Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression Medical Conditions
• Primary immunodeficiency
• Severe or uncontrolled autoimmune disorder
• History or presence of clinically relevant CNS pathology such as epilepsy, seizure, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
• Unresolved immune effector cell-associated neurotoxicity syndrome (ICANS) from prior CAR T cell administration. Consideration for Grade 1 may be made after discussion with the Medical Monitor
• History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, breast, and/or prostate) unless disease free for at least 3 years
• Cardiac conditions:
• Medically uncontrolled hypertension (≥ 160 mmHg systolic blood pressure or ≥ 100 mmHg diastolic blood pressure)
• Congestive heart failure Class ≥ II as defined by the New York Heart Association
• Acute coronary syndrome (including unstable angina, coronary artery stenting, or angioplasty, bypass grafting within prior 6 months)
• History or evidence of current, uncontrolled, clinically significant, unstable arrhythmias
• Oxygen saturation at room air < 92%
• Participant has known human immunodeficiency virus (HIV) infection, or active hepatitis B virus (HBV)/hepatitis C virus (HCV) infection
• Acute bacterial, viral, fungal infection requiring systemic therapy (uncomplicated urinary tract infection and bacterial pharyngitis are permitted if responding to therapy)
• History of severe allergic reactions to any of the study intervention components including conditioning regimen, dimethyl sulfoxide (DMSO) or to tocilizumab
• Clinically significant reversible toxicities from prior cancer therapy that have not recovered to Grade 1 or baseline
• Participants with Grade 2 neuropathies due to prior treatment will be allowed on study.
• Participants with clinical nonsignificant toxicities, such as alopecia, will be allowed on study.
• Prior/Concomitant Therapy
• Prior to Apheresis:

Where it is running

• City of Hope — Duarte, California, United States (enrolling)
• University of Colorado — Aurora, Colorado, United States (enrolling)
• Colorado Blood Cancer Institute (Sarah Cannon) — Denver, Colorado, United States (enrolling)
• University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
• Cornell — New York, New York, United States (enrolling)
• Sarah Cannon Research Institute at St. David's South Austin — Austin, Texas, United States (enrolling)
• University of Wisconsin Carbone Cancer Center — Madison, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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