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

Part of paid clinical trials in Duarte, California.

Sponsor
Marker Therapeutics, Inc.
Study ID
NCT05798897
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Hodgkin Lymphoma
  • Hodgkin Lymphoma, Adult
  • Hodgkin's Lymphoma, Relapsed, Adult
  • Non Hodgkin Lymphoma
  • Non-Hodgkin Lymphoma, Adult
  • Non-Hodgkin Lymphoma, Refractory
  • Non-Hodgkin Lymphoma, Relapsed

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • MT-601 — DRUG
    Multi-antigen specific CD4+ andCD8+ T cells

Study Details

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 Dates

Start date
Jan 2, 2023
Status verified
Aug 2025
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
79 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm Study
    Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose

Primary Outcome Measure

Dose Escalation [ Time Frame: After 3 or 6 patients in each dose cohort have been treated with MT-601 and have had the opportunity to be followed for 28 days. ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Geoffrey Shouse, DO, PhD
[email protected]
626-218-2405
Elizabeth Nguyen
[email protected]
(626) 218-2807
Geoffrey Shouse, DO, PhD (PRINCIPAL_INVESTIGATOR)
University of ColoradoAuroraColorado80045
Manali Kamdar, MD
[email protected]
720-848-0752
Celeste Canel
[email protected]
303-724-2692
Colorado Blood Cancer Institute (Sarah Cannon)DenverColorado80218
Luke Mountjoy, DO
[email protected]
720-754-4800
Mallori Buresh
[email protected]
Luke Mountjoy, DO (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical CenterKansas CityKansas66160
Cari Stockard
[email protected]
913-588-0512
Haitham Abdelhakim, MD (PRINCIPAL_INVESTIGATOR)
CornellNew YorkNew York10065
Nicole Santos
[email protected]
Samuel Yamshon, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute at St. David's South AustinAustinTexas78704
Aravind Ramakrishnan, MD
[email protected]
512-816-8600
Eliza Harbert
[email protected]
512-816-5643
Aravind Ramakrishnan, MD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Mariah Endres
608-262-7657
Priyanka Pophali, MD (PRINCIPAL_INVESTIGATOR)

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