A Phase 1 Multicenter Study Evaluating the Safety and Efficacy of ACE1831, an Allogeneic Anti-CD20 Antibody-Conjugated Gamma Delta T-cell Therapy, in Adult Subjects With Relapsed/Refractory CD20-expressing B-cell Malignancies
Status: Recruiting
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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 or subjects with ECOG scores of 2 with a serum albumin of \>3.5
• Adequate hematologic and renal, hepatic, and cardiac function
• Oxygen saturation via pulse oxygenation ≥ 92% at rest on room air
Locations
United States
Florida
AdventHealth Orlando
RECRUITING
Orlando
Georgia
Emory University
RECRUITING
Atlanta
Indiana
Indiana University Simon Comprehensive Cancer Center
TERMINATED
Indianapolis
Kentucky
Norton Cancer Institute
RECRUITING
Louisville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital
RECRUITING
Hong Kong
Taiwan
Kaohsiung Chang-Gung Memorial Hospital
RECRUITING
Kaohsiung City
Ministry of Health and Welfare Shuang-Ho Hospital
RECRUITING
New Taipei City
Tamsui MacKay Memorial Hospital
RECRUITING
New Taipei City
Taichung Veterans General Hospital
RECRUITING
Taichung
National Cheng Kung University Hospital
RECRUITING
Tainan City
National Taiwan University Hospital
RECRUITING
Taipei
Linkou Chang-Gung Memorial Hospital
RECRUITING
Taoyuan
Contact Information
Primary
Stephanie Chien
clinical@acepodiabio.com
+1 415-366-7822
Time Frame
Start Date:2023-01-21
Estimated Completion Date:2027-09
Participants
Target number of participants:42
Treatments
Experimental: Treatment Group A (ACE1831)
ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.
Experimental: Treatment Group B (ACE1831 and obinutuzumab)
ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.