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CAR T-cell Therapy
ACE1831 Cell Therapy for B-Cell Lymphoma
Phase 1
Recruiting
Research Sponsored by Acepodia Biotech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a cell therapy made from healthy donors to treat CD20 related cancers.
Who is the study for?
This trial is for adults with certain types of B-cell Non-Hodgkin's Lymphoma that have tried at least two other treatments without success. Participants should be relatively healthy, able to perform daily activities with ease (ECOG 0-1), and not have a history of central nervous system lymphoma or other significant health issues like active infections or severe heart disease.Check my eligibility
What is being tested?
The study tests ACE1831, an experimental cell therapy made from donor T cells targeting CD20 in B-cell malignancies. It's given alongside standard drugs Cyclophosphamide, Fludarabine, and Obinutuzumab to see how safe it is and how well it works against the cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune cell infusion, effects on blood counts due to chemotherapy agents (Cyclophosphamide and Fludarabine), as well as possible infusion-related reactions from the antibody treatment (Obinutuzumab).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline clinical laboratory tests results
Change from baseline in ECOG status
Change from baseline in electrocardiogram (ECG) results
+5 moreSecondary outcome measures
Measure of anti-ACE1831 antibodies after administration
Objective Response Rate (ORR)
Persistence of ACE1831 after administration
Other outcome measures
Pharmacodynamics of ACE1831
Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment Group B (ACE1831 and obinutuzumab)Experimental Treatment4 Interventions
ACE1831 dose escalation, in combination with obinutuzumab. Lymphodepleting regimen followed by escalating doses of ACE1831, given in combination with obinutuzumab.
Group II: Treatment Group A (ACE1831)Experimental Treatment3 Interventions
ACE1831 dose escalation, monotherapy. Lymphodepleting regimen followed by escalating doses of ACE1831.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1100
Obinutuzumab
2015
Completed Phase 3
~3250
Find a Location
Who is running the clinical trial?
Acepodia Biotech, Inc.Lead Sponsor
1 Previous Clinical Trials
36 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with a gene-modified therapy targeting CD20.I currently have a serious infection.I have HIV, active hepatitis B, or hepatitis C.My blood, kidney, liver, and heart functions are all within normal ranges.My B-cell NHL has not improved after 2 treatments.I am fully active or can carry out light work.I have a significant brain disorder like epilepsy.I have had lymphoma in my brain or spinal cord.I have a serious heart condition right now.I have had cancer before, but it's treated and currently shows no signs of returning.I have had a stem cell transplant using my own cells recently or a transplant from a donor before.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group A (ACE1831)
- Group 2: Treatment Group B (ACE1831 and obinutuzumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are eligible for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical research project has been opened for enrollment since January 31st 2023 and was recently updated on the 24th of that same month. 42 individuals are being sought from a single site."
Answered by AI
Are there still vacancies available to volunteer in this clinical investigation?
"Indeed, clinicaltrials.gov confirms that this investigation is actively recruiting participants from a single site. The study was initially posted on January 31st 2023 and edited for the last time on January 24th of the same year; 42 patients are expected to take part in it."
Answered by AI
How efficacious is the combination of ACE1831 and obinutuzumab in terms of patient safety?
"Our team's assessment of the safety profile for Treatment Group B (ACE1831 and obinutuzumab) is 1 out of 3 due to the limited data from its Phase One trial, which gives us an incomplete picture of efficacy and security."
Answered by AI
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