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Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma (APOLLO)

Primary Purpose

Non-Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Refractory, Non-Hodgkin Lymphoma, Relapsed

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MT-601
Sponsored by
Marker Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Hodgkin Lymphoma, Adult focused on measuring NHL, Lymphoma

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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). Patients are eligible to be included in the study only if all of the following criteria apply and the patient, in the judgement of the Investigator, is an appropriate candidate for experimental therapy: Cytologically or histologically confirmed diagnosis of Non-Hodgkin Lymphoma (in any subtype where CD19+ T cell therapy is approved, e.g., DLBCL, MCL, FL) Relapsed or refractory to CD19+ CAR T cell therapy or ineligible for CD19+ CAR T cell therapy (includes patients whose BOR of SD following CD19+ CAR T cell therapy). Patients who have had only BOR of PR to CD19+ CAR T cell therapy may also enroll Are ≥18 years of age prior to administration of MT-601 Patients must have patient-derived cells available to make MT-601 Karnofsky/Lansky 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, and renal function Blood: Hemoglobin ≥7.0 g/dL (can be transfused) Liver: Bilirubin ≤1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome); aspartate aminotransferase ≤3X ULN Renal: Serum creatinine ≤2X ULN or measured or calculated creatinine clearance ≥30mL/min Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period At least 4 half-lives or 1 week has passed after administration of prior therapy or bridging therapy Dose escalation defined as patients whose prior treatment course does not meet precise eligibility criteria but may still be approved upon review by the Sponsor Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: Clinically significant or severely symptomatic intercurrent infection (e.g. patients with uncontrolled HIV infection or have active HBV/HCV infection) Pregnant or lactating Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study Taking systemic corticosteroids (exception: physiological doses of steroids allowed) Autologous or allogeneic HSCT within 1 month

Sites / Locations

  • City of HopeRecruiting
  • Colorado Blood Cancer Institute (Sarah Cannon)Recruiting
  • Tennessee Oncology PLLCRecruiting
  • Sarah Cannon Research Institute at St. David's South AustinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm Study

Arm Description

Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose

Outcomes

Primary Outcome Measures

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)
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 14, 2023
Last Updated
April 4, 2023
Sponsor
Marker Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05798897
Brief Title
Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
Acronym
APOLLO
Official Title
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 Lymphoma (NHL [APOLLO])
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2023 (Actual)
Primary Completion Date
February 28, 2028 (Anticipated)
Study Completion Date
February 28, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marker Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is a Phase 1multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory NHL. The dose administered is 200 x 10^6 cells (flat dosing).
Detailed Description
This study is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in patients with relapsed or refractory Non-Hodgkin lymphoma (NHL) who either received CD19+ chimeric antigen receptor (CAR) T cell therapy or are ineligible for CD19+ CAR T cell therapy. The study will consist of two portions: 1) Dose Escalation (3+3 design) followed by 2) Dose Expansion. The purpose of the Dose Escalation portion of the study is to test safety and tolerability of higher doses of MT-601 up to 400 x 106 cells. The Dose Expansion portion of this study will begin after completion of the Dose Escalation portion. The purpose of the Dose Expansion portion of the study is to evaluate the clinical efficacy of MT-601 at the dose determined to be safe in the Dose Escalation portion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Hodgkin Lymphoma, Adult, Non-Hodgkin Lymphoma, Refractory, Non-Hodgkin Lymphoma, Relapsed, Non Hodgkin Lymphoma
Keywords
NHL, Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm Study
Arm Type
Experimental
Arm Description
Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose
Intervention Type
Drug
Intervention Name(s)
MT-601
Intervention Description
Multi-antigen specific CD4+ andCD8+ T cells
Primary Outcome Measure Information:
Title
Dose Escalation
Description
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)
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.
Title
Dose Expansion (ORR)
Description
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.
Time Frame
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Title
Dose Expansion (DOR)
Description
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.
Time Frame
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.
Title
Dose Expansion (CR)
Description
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.
Time Frame
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Patients are eligible to be included in the study only if all of the following criteria apply and the patient, in the judgement of the Investigator, is an appropriate candidate for experimental therapy: Cytologically or histologically confirmed diagnosis of Non-Hodgkin Lymphoma (in any subtype where CD19+ T cell therapy is approved, e.g., DLBCL, MCL, FL) Relapsed or refractory to CD19+ CAR T cell therapy or ineligible for CD19+ CAR T cell therapy (includes patients whose BOR of SD following CD19+ CAR T cell therapy). Patients who have had only BOR of PR to CD19+ CAR T cell therapy may also enroll Are ≥18 years of age prior to administration of MT-601 Patients must have patient-derived cells available to make MT-601 Karnofsky/Lansky 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, and renal function Blood: Hemoglobin ≥7.0 g/dL (can be transfused) Liver: Bilirubin ≤1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome); aspartate aminotransferase ≤3X ULN Renal: Serum creatinine ≤2X ULN or measured or calculated creatinine clearance ≥30mL/min Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period At least 4 half-lives or 1 week has passed after administration of prior therapy or bridging therapy Dose escalation defined as patients whose prior treatment course does not meet precise eligibility criteria but may still be approved upon review by the Sponsor Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: Clinically significant or severely symptomatic intercurrent infection (e.g. patients with uncontrolled HIV infection or have active HBV/HCV infection) Pregnant or lactating Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study Taking systemic corticosteroids (exception: physiological doses of steroids allowed) Autologous or allogeneic HSCT within 1 month
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mythili Koneru, MD, PhD
Phone
713.400.6400
Email
mkoneru@markertherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Garrett
Phone
713.400.6400
Email
ggarrett@markertherapeutics.com
Facility Information:
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey Shouse, DO, PhD
Phone
626-218-2405
Email
gshouse@coh.org
First Name & Middle Initial & Last Name & Degree
Geoffrey Shouse, DO, PhD
Facility Name
Colorado Blood Cancer Institute (Sarah Cannon)
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luke Mountjoy, DO
Phone
720-754-4800
Email
Luke.Mountjoy@HealthONECares.com
First Name & Middle Initial & Last Name & Degree
Luke Mountjoy, DO
Facility Name
Tennessee Oncology PLLC
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Flinn, MD, PhD
Phone
615-329-7274
Email
iflinn@tnonc.com
First Name & Middle Initial & Last Name & Degree
Ian Flynn, MD, PhD
Facility Name
Sarah Cannon Research Institute at St. David's South Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aravind Ramakrishnan, MD
Phone
512-816-8600
Email
Aravind.Ramakrishnan@hcahealthcare.com
First Name & Middle Initial & Last Name & Degree
Aravind Ramakrishnan, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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