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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Acepodia Biotech, Inc.
Study ID
NCT05653271
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • B-cell Lymphoma
  • Burkitt Lymphoma
  • DLBCL
  • Follicular Lymphoma
  • High-grade B-cell Lymphoma
  • Marginal Zone Lymphoma
  • Non Hodgkin Lymphoma
  • Primary Mediastinal Large B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Lymphodepleting agent
  • Fludarabine — DRUG
    Lymphodepleting agent
  • ACE1831 — DRUG
    Allogeneic gamma delta T (gdT) cell therapy
  • Obinutuzumab — DRUG
    Anti-CD20 monoclonal antibody

Study Details

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.

Key Dates

Start date
Jan 21, 2023
Status verified
Aug 2025
Primary completion
Sep 30, 2025
Completion
Sep 30, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Incidence of adverse events (AEs), Dose Limiting Toxicities (DLTs), adverse events of special interest (AESIs), and serious adverse events (SAEs) [ Time Frame: 2 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
AdventHealth OrlandoOrlandoFlorida32804
Rushang D Patel, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Amelia Langston, MD (PRINCIPAL_INVESTIGATOR)
Indiana University Simon Comprehensive Cancer CenterIndianapolisIndiana46202-
Norton Cancer InstituteLouisvilleKentucky40207
MD
Don A Stevens, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Ranjit Nair, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Orlando, FL

By research site
AdventHealth Orlando· Orlando, FLEmory University· Atlanta, GAIndiana University Simon Comprehensive Cancer Center· Indianapolis, INNorton Cancer Institute· Louisville, KYThe University of Texas MD Anderson Cancer Center· Houston, TX

Related Studies