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CAR T-cell Therapy
ADI-001 for Non-Hodgkin's Lymphoma (GLEAN-1 Trial)
Phase 1
Recruiting
Research Sponsored by Adicet Bio, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Relapsed/refractory (R/R) previously treated B cell malignancies
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
GLEAN-1 Trial Summary
This trial is testing a new cancer drug to see if it is safe and effective. So far, the results look promising.
Who is the study for?
Adults with certain B cell malignancies who've had at least two prior treatments, including anti-CD20 antibody therapies. They must have measurable disease, be in good physical condition (ECOG PS of 0 or 1), and not pregnant or breastfeeding. Participants need to use effective birth control and can't join if they've had CNS lymphoma, recent unrelated cancers, gene therapy within six weeks, radiation within four weeks (except palliative), stem cell transplant within six weeks, or allogeneic transplant within three months.Check my eligibility
What is being tested?
The trial is testing ADI-001 combined with Fludarabine and Cyclophosphamide in patients with various types of B-cell lymphomas. It's a Phase 1 study using a '3+3' design to find the safest dose that also works effectively against the cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as fever and fatigue; organ inflammation; blood disorders due to bone marrow suppression from chemotherapy drugs like Fludarabine and Cyclophosphamide; infusion-related reactions; increased risk of infections.
GLEAN-1 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My B cell cancer has returned or didn't respond to treatment.
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I am fully active or can carry out light work.
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I agree to use effective birth control during the study.
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I am not pregnant or breastfeeding.
GLEAN-1 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of treatment emergent and treatment related adverse events
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Secondary outcome measures
Duration of Response
Frequency and persistence of ADI-001
Overall Response Rate by Lugano Criteria
+3 moreGLEAN-1 Trial Design
3Treatment groups
Experimental Treatment
Group I: ADI-001 Dose ExtensionExperimental Treatment3 Interventions
ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).
Group II: ADI-001 Dose ExpansionExperimental Treatment3 Interventions
Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
Group III: ADI-001 Dose EscalationExperimental Treatment3 Interventions
ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001 (Part 1a).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
Adicet Bio, IncLead Sponsor
2 Previous Clinical Trials
90 Total Patients Enrolled
Adicet Medical DirectorStudy DirectorAdicet Bio
Rose Lai, MDStudy DirectorAdicet Bio
1 Previous Clinical Trials
50 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to participate in long-term follow-up for safety monitoring.My B cell cancer has returned or didn't respond to treatment.I have or had lymphoma in my brain or spinal cord.I haven't had any cancer treatments except for hormone therapy in the last 3 years.I am 18 years old or older.I do not have severe graft versus host disease or need for recent immunosuppressive treatment.I have not had radiation therapy in the last 4 weeks, except for palliative care.My tumor is causing problems like blocking my intestines or pressing on blood vessels.I am fully active or can carry out light work.I haven't had gene or cell therapy in the last 6 weeks.I do not have any health or mental conditions that could make this study riskier for me.My blood, kidney, lung, heart, and liver functions are all within normal ranges.I've had at least 2 treatments including anti-CD20 therapy. I may have had CD19 CAR T therapy.I had a stem cell transplant less than 6 weeks ago.I had a bone marrow transplant and donor immune cell treatment within the last 3 months.I agree to use effective birth control during the study.I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: ADI-001 Dose Escalation
- Group 2: ADI-001 Dose Extension
- Group 3: ADI-001 Dose Expansion
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.
What further research has been conducted on the efficacy of ADI-001?
"Currently, 958 trials are researching the effects of ADI-001 with 176 studies in their final stage. While Philadelphia is home to most of these experiments, there are a total of 32509 locations investigating this medication."
Answered by AI
What are some common applications for ADI-001?
"ADI-001 has shown potential for treating multiple sclerosis, leukemia, myelocytic disorder, acute illness and retinoblastoma."
Answered by AI
How many locales are offering this research study?
"At this moment, 8 different medical centres are accepting participants for the trial. These locations span across Louisville, Stanford and Iowa City as well as a few other locales. To reduce travel costs, it is recommended to pick a site closeby if you decide to join in on the study."
Answered by AI
Has the FDA sanctioned ADI-001?
"The risk profile attributed to ADI-001 in our evaluation was 1, as this is an initial clinical trial and there is limited information available on its safety or efficacy."
Answered by AI
Does this research protocol accept new participants?
"Clinicaltrials.gov affirms that this experiment is recruiting participants; the original post was available from March 4th 2021, with recent revisions taking place on October 19th 2022."
Answered by AI
How many participants have been recruited for this clinical research?
"This clinical trial needs 78 qualified candidates to be successful; Adicet Bio, Inc. is sponsoring the study and will carry it out at Norton Cancer Institute in Louisville, Kentucky and Stanford University Medical Centre in Stanford, California."
Answered by AI
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