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ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies

Primary Purpose

B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cyclophosphamide
Fludarabine
ACE1831
Obinutuzumab
Sponsored by
Acepodia Biotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Lymphoma

Eligibility Criteria

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

Key Inclusion Criteria: CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Adequate hematologic and renal, hepatic, and cardiac function Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air Key Exclusion Criteria: Prior treatment with a genetically modified cell therapy product targeting CD20 Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation History of central nervous system (CNS) lymphoma or primary CNS lymphoma History or presence of clinically relevant CNS disorder (e.g. epilepsy) Clinically significant active infection Currently active, clinically significant cardiovascular disease Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection History of other malignancies with the exception of certain treated malignancies with no evidence of disease Primary immunodeficiency disorder Pregnant or lactating female Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent

Sites / Locations

  • AdventHealth OrlandoRecruiting
  • Emory UniversityRecruiting
  • Norton Cancer InstituteRecruiting
  • Hackensack University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment Group A (ACE1831)

Treatment Group B (ACE1831 and obinutuzumab)

Arm Description

ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.

ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Change from baseline in ECOG status
Change from baseline in physical examination results
Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive)
Change from baseline clinical laboratory tests results
Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
Change from baseline in urinalysis results
Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
Change from baseline in vital signs results
Number of subjects with change from baseline clinical significant vital signs findings by dose level (descriptive)
Change from baseline in electrocardiogram (ECG) results
Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
Maximum Tolerated Dose (MTD)

Secondary Outcome Measures

Persistence of ACE1831 after administration
Half-life of ACE1831
Measure of anti-ACE1831 antibodies after administration
Titration of anti-ACE1831 antibodies after administration
Objective Response Rate (ORR)
Objective response of each patient's underlying lymphoma, duration of response, and progression-free survival all based on the revised IWG Response Criteria for Malignant Lymphoma

Full Information

First Posted
November 2, 2022
Last Updated
May 28, 2023
Sponsor
Acepodia Biotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05653271
Brief Title
ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies
Official Title
A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic CD20-conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acepodia Biotech, Inc.

4. Oversight

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

5. Study Description

Brief Summary
ACE1831 is an off-the-shelf, allogeneic gamma delta T (gdT) cell therapy derived from healthy donors, that is under investigation for the treatment of CD20-expressing B-cell malignancies. The ACE1831-001 study is an open-label, Phase I, first-in-human (FIH) study that aims to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, and efficacy of ACE1831 in patients with CD20-expressing Non-Hodgkin lymphoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Lymphoma, Non Hodgkin Lymphoma, DLBCL, Primary Mediastinal Large B Cell Lymphoma, Marginal Zone Lymphoma, Follicular Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group A (ACE1831)
Arm Type
Experimental
Arm Description
ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.
Arm Title
Treatment Group B (ACE1831 and obinutuzumab)
Arm Type
Experimental
Arm Description
ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Lymphodepleting agent
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
Lymphodepleting agent
Intervention Type
Drug
Intervention Name(s)
ACE1831
Intervention Description
Allogeneic gamma delta T (gdT) cell therapy
Intervention Type
Drug
Intervention Name(s)
Obinutuzumab
Intervention Description
Anti-CD20 monoclonal antibody
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Time Frame
2 years
Title
Change from baseline in ECOG status
Time Frame
1 year
Title
Change from baseline in physical examination results
Description
Number of subject with change from baseline clinically significant physical examination findings by dose level (descriptive)
Time Frame
1 year
Title
Change from baseline clinical laboratory tests results
Description
Number of subjects with change from baseline clinically significant lab findings by dose level (descriptive)
Time Frame
1 year
Title
Change from baseline in urinalysis results
Description
Number of subjects with change from baseline clinically significant urinalysis findings by dose level (descriptive)
Time Frame
1 year
Title
Change from baseline in vital signs results
Description
Number of subjects with change from baseline clinical significant vital signs findings by dose level (descriptive)
Time Frame
1 year
Title
Change from baseline in electrocardiogram (ECG) results
Description
Number of subjects with change from baseline clinically significant ECG findings by dose level (descriptive)
Time Frame
1 month
Title
Maximum Tolerated Dose (MTD)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Persistence of ACE1831 after administration
Description
Half-life of ACE1831
Time Frame
1 month
Title
Measure of anti-ACE1831 antibodies after administration
Description
Titration of anti-ACE1831 antibodies after administration
Time Frame
1 month
Title
Objective Response Rate (ORR)
Description
Objective response of each patient's underlying lymphoma, duration of response, and progression-free survival all based on the revised IWG Response Criteria for Malignant Lymphoma
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
Pharmacodynamics of ACE1831
Description
Serum levels of interferon-γ, TNF-α, IL-2, IL-6, IL-8 and IL-10, as well as other potential biomarkers
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: CD20-positive B-cell NHL that is persistent or progressive after having received at least 2 prior systemic therapies per NCCN guidelines At least 1 measurable lesion according to the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 Adequate hematologic and renal, hepatic, and cardiac function Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air Key Exclusion Criteria: Prior treatment with a genetically modified cell therapy product targeting CD20 Autologous stem cell transplant within 6 weeks of informed consent or history of allogeneic stem cell transplantation History of central nervous system (CNS) lymphoma or primary CNS lymphoma History or presence of clinically relevant CNS disorder (e.g. epilepsy) Clinically significant active infection Currently active, clinically significant cardiovascular disease Human Immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection History of other malignancies with the exception of certain treated malignancies with no evidence of disease Primary immunodeficiency disorder Pregnant or lactating female Any medical, psychological, familial, or sociological conditions that, in the opinion of the Investigator or Sponsor Medical Monitor, would impair the ability of the subject to receive study treatment, comply with study requirements, or understanding of the informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie Chien
Phone
+1 415-366-7822
Email
clinical@acepodiabio.com
Facility Information:
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rushang D Patel, MD
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Romancik, MD
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MD
First Name & Middle Initial & Last Name & Degree
Don A Stevens, MD
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lori Leslie, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ACE1831 in Adult Subjects With Relapsed/ Refractory CD20-expressing B-cell Malignancies

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