A Phase I Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Malignancy Activity of AC676 in Patients With Relapsed/Refractory B-cell Malignancies
Sponsor study identifier
interventional
60
1 country
9
Study Start
June 20, 2023
Actual (reported)Primary Completion
March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This clinical trial is evaluating a drug called AC676 in participants with Relapsed/Refractory B-cell Malignancies. The main goals of the study are to:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 10, 2023
Actual (reported)March 22, 2023
Actual (reported)June 20, 2023
Actual (reported)March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Incidence of dose limiting toxicities (DLTs) from AC676 monotherapy
From cycle 1 day 1 to Cycle 1 day 28. Cycles are 28 days.
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant Grade 3 or higher laboratory abnormalities using CTCAE v5.0 criteria.
Approximately 18 months
Maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D)
Approximately 18 months
Participants will receive an assigned dose of AC676 in a 28-days cycle.
AC676 will be given orally (PO) on a 28-day cycle.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Colorado Blood Cancer Institute
Denver, Colorado, 80218, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
University Hospitals Cleveland Medical Center
First Submitted
March 10, 2023
First Posted
March 22, 2023
Study Start
June 20, 2023
Actual (reported)Primary Completion
March 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
CD19 CAR T Cells in Children and Adults With Relapsed or Refractory CD19 Positive B Cell Malignancies
Pharmacokinetic Analysis: area under the plasma concentration-time curve over the dosing interval (AUC(0-inf))
Up to approximately 20 weeks
Pharmacokinetic Analysis: area under the plasma concentration-time curve from over the dosing interval (AUC(0-tau))
Up to approximately 20 weeks
Pharmacokinetic Analysis: maximum plasma concentration (Cmax)
Up to approximately 20 weeks
Pharmacokinetic Analysis: time to maximum plasma concentration (tmax)
Up to approximately 20 weeks
Pharmacokinetic Analysis: terminal elimination half-life (t1/2)
Up to approximately 20 weeks
Contact the study team to confirm eligibility.
Cleveland, Ohio, 44106, United States
The Ohio State University - The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Tennessee Oncology
Nashville, Tennessee, 37302, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
Study Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 2, 2025
Record last verified: 2025-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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