Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
APOLLO
A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)
1 other identifier
interventional
79
1 country
7
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2023
Longer than P75 for phase_1
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 2, 2023
CompletedFirst Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2028
August 20, 2025
August 1, 2025
5.2 years
March 14, 2023
August 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Dose Escalation
To assess safety and tolerability of escalating doses of MT-601 by the number of participants with MT-601 Dose Limiting Toxicities (DLTs) and Safety events (including but not limited to): treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), deaths, and clinical laboratory abnormalities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
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.
Dose Expansion (ORR)
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Objective response rate (ORR) defined as the proportion of treated patients who achieve a best response of complete remission (CR) or partial response (PR) per Lugano Classification. * The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for ORR.
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Dose Expansion (DOR)
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Duration of response (DOR) defined for patients who attain a best response of CR or PR and is the time between the date of first documented CR or PR and the date of the first observed progression per Lugano Classification. * DOR will be estimated using the Kaplan-Meier (KM) product limit method. The median DOR and corresponding 95% confidence intervals (CI) will be estimated.
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Dose Expansion (CR)
To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Complete remission (CR) rate defined as the proportion of treated patients who achieve a best response of CR per Lugano Classification. * The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for CR rate estimates.
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Study Arms (1)
Single Arm Study
EXPERIMENTALSingle arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose
Interventions
Eligibility Criteria
You may not qualify if:
- 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)
- MCL
- MZL
- 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
- +62 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
City of Hope
Duarte, California, 91010, United States
University of Colorado
Aurora, Colorado, 80045, United States
Colorado Blood Cancer Institute (Sarah Cannon)
Denver, Colorado, 80218, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Cornell
New York, New York, 10065, United States
Sarah Cannon Research Institute at St. David's South Austin
Austin, Texas, 78704, United States
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
April 5, 2023
Study Start
January 2, 2023
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
February 28, 2028
Last Updated
August 20, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share