Actively Recruiting
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
Led by Marker Therapeutics, Inc. · Updated on 2025-08-20
79
Participants Needed
7
Research Sites
269 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is 18 years of age or older and can give informed consent
- Confirmed diagnosis of non-Hodgkin lymphoma, Hodgkin lymphoma, or chronic lymphocytic leukemia according to WHO 2022 criteria
- Eligible lymphoma subtypes include LBCL, FL, MCL, MZL, HL, and possibly CLL/SLL, CNS lymphoma, or CAR T cell refractory in expansion phase
- Measurable disease present according to Lugano or iwCLL criteria
- Relapsed or refractory to at least 2 prior therapies, intolerant, or ineligible for standard anticancer treatments
- For LBCL, FL, MCL: prior CD19-directed CAR T cell therapy with relapse or incomplete response within 1 year, or refusal/ineligibility for CAR T therapy
- Karnofsky score of 70 or higher or ECOG performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate blood, liver, kidney, and heart function as specified
- Women of childbearing potential must use effective contraception during and 6 months after treatment and agree not to donate eggs
- Male participants must agree to contraceptive measures and not donate sperm during and 6 months after treatment
You will not qualify if you...
- Presence of bulky disease at conditioning regimen (≥10 cm for LBCL or HL, >6 cm for others)
- Untreated or ongoing treatment for CNS lymphoma within 2 weeks before apheresis (may be allowed in expansion phase)
- Refractory to CAR T therapy defined as stable disease or progression (may be allowed in expansion phase)
- Need for urgent therapy due to tumor mass effects
- Primary immunodeficiency or severe/uncontrolled autoimmune disorder
- Significant CNS disorders such as epilepsy, stroke, dementia, or psychosis
- Unresolved neurotoxicity syndrome (ICANS) from prior CAR T therapy
- History of other malignancies unless disease-free for 3 years
- Uncontrolled cardiac conditions or oxygen saturation <92%
- Known HIV or active hepatitis B or C infection
- Active infections requiring systemic therapy except certain uncomplicated infections
- Severe allergic reactions to study treatments or components
- Unrecovered significant toxicities from prior cancer therapies except certain neuropathies or alopecia
- Recent allogeneic or autologous hematopoietic cell transplant within specified timelines
- Recent treatments with CAR T therapy, bispecific antibodies, antibody drug conjugates, PD-1/PD-L1 agents, monoclonal antibodies, immunosuppressants, chemotherapy, radiation, tyrosine kinase inhibitors, or major surgery within specified timelines
- Treatment with experimental CAR T products without approval
- Pregnant or lactating women
- Any other condition considered by the physician to make the participant unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Colorado Blood Cancer Institute (Sarah Cannon)
Denver, Colorado, United States, 80218
Actively Recruiting
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
5
Cornell
New York, New York, United States, 10065
Actively Recruiting
6
Sarah Cannon Research Institute at St. David's South Austin
Austin, Texas, United States, 78704
Actively Recruiting
7
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
J
Juan Vera, MD
CONTACT
P
Patricia Allison
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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