- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04735471
A Safety and Efficacy Study of ADI-001, an Anti-CD20 Allogeneic Gamma Delta CAR-T, in Subjects With B Cell Malignancies (GLEAN-1)
A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T Cells in Adults With B Cell Malignancies
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
ADI-001 is an investigational immunotherapy composed of allogeneic gamma delta T cells that is being evaluated as a potential treatment for patients diagnosed with B cell malignancies who have relapsed or are refractory to at least two prior regimens. This first-in-human study will assess the safety and tolerability of ADI-001 and is designed to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD). Patients will be administered a single infusion or multiple infusions of ADI-001 cells. The study will include the following two parts:
Part 1 : dose escalation and extension. Parts 1a (escalation) and 1b (extension) will involve escalation and administration of single dose of ADI-001 and multiple doses of ADI-001.
Part 2 : dose expansion will involve dose administration of ADI-001 at MTD/MAD as determined in Part 1.
The study will also assess the pharmacokinetics and pharmacodynamics of ADI-001.
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Rose Lai, MD
- Phone Number: 6263181179
- Email: clinicaltrials@adicetbio.com
Study Locations
-
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California
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Stanford, California, United States, 94305
- Recruiting
- Stanford University Medical Center
-
Contact:
- David Miklos, MD
- Phone Number: 650-723-0822
- Email: dmiklos@stanford.edu
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Florida
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Miami, Florida, United States, 33136
- Recruiting
- University of Miami- Sylvester Comprehensive Cancer Center
-
Contact:
- Jay Spiegel, MD
- Email: spiegelj@med.miami.edu
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Georgia
-
Atlanta, Georgia, United States, 30342
- Recruiting
- Northside Hospital Blood and Marrow Transplant Group of Georgia
-
Contact:
- Asad Bashey, MD
- Email: abashey@btmga.com
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Iowa
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Iowa City, Iowa, United States, 52242
- Recruiting
- The State University of Iowa
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Contact:
- Umar Farooq, MD
- Email: umar-farooq@uiowa.edu
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Kentucky
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Louisville, Kentucky, United States, 40207
- Recruiting
- Norton Cancer Institute
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Contact:
- Don A Stevens, MD
- Phone Number: 502-899-3366
- Email: Don.Stevens@nortonhealthcare.org
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Texas
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Dallas, Texas, United States, 75204
- Recruiting
- Baylor Scott & White Research Institute
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Contact:
- Houston Holmes, MD
- Phone Number: 214-370-1000
- Email: houston.holmes@usoncology.com
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Houston, Texas, United States, 77030
- Recruiting
- MD Anderson Cancer Center
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Contact:
- Sattva Neelapu, MD
- Email: SNeelapu@mdanderson.org
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Medical College of Wisconsin
-
Contact:
- Mehdi Hamadani, MD
- Phone Number: 414-805-0505
- Email: mhamadani@mcw.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Relapsed/refractory (R/R) previously treated B cell malignancies.
- Prior treatment must include at least 2 prior regimens, including anti CD20 antibody therapies. Prior Treatment with CD19 CAR T may be considered.
- Documented measurable disease as defined by Lugano 2014
- Male or female ≥ 18 years of age
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
- Adequate hematological, renal, pulmonary, cardiac, and liver function
- Female patients who are not pregnant or breastfeeding
- Female patients of childbearing potential and all male patients must agree to use highly effective methods of birth control for the duration of the study.
Exclusion Criteria:
Current or history of any of the following conditions:
- Central nervous system (CNS) primary lymphoma (current or history)
- Unrelated malignancy requiring systemic treatment (current or history [in the past 3 years, other than hormonal treatment which is allowed])
Any of the following current conditions:
- Active acute or chronic graft versus host disease (GvHD) other than grade 1 with skin involvement, or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment
- Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration
- Tumor mass effects such as bowel obstruction or blood vessel compression that require therapy
- Opportunistic infections
- History of any clinically significant conditions in the opinion of the Investigator
Prior treatment with any of the following:
a Gene therapy, genetically modified cell therapy, or adoptive T cell therapy within 6 weeks of study enrollment.
b Radiation therapy within 4 weeks prior to study entry. Palliative local radiation may be allowed within 1 week prior to study entry.
c Autologous stem cell transplant (SCT) within 6 weeks of planned ADI 001 infusion d Allogeneic transplant and donor lymphocyte infusion within 3 months of planned CAR T cell infusion
- Patients unwilling to participate in an extended safety monitoring period (long term follow up [LTFU] protocol)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ADI-001 Dose Escalation
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).
|
Anti-CD20 CAR-T
Chemotherapy for Lymphodepletion
Chemotherapy for Lymphodepletion
|
Experimental: ADI-001 Dose Extension
ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).
|
Anti-CD20 CAR-T
Chemotherapy for Lymphodepletion
Chemotherapy for Lymphodepletion
|
Experimental: ADI-001 Dose Expansion
Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
|
Anti-CD20 CAR-T
Chemotherapy for Lymphodepletion
Chemotherapy for Lymphodepletion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Time Frame: Day 28
|
This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD).
|
Day 28
|
Proportion of treatment emergent and treatment related adverse events
Time Frame: 1 year
|
This primary endpoint will be used to determine the MTD/MAD of ADI-001
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Frequency and persistence of ADI-001
Time Frame: Day 1 through Month 12
|
Defined as duration from Day 1 to undetectable levels of ADI-001 cells per microliter blood
|
Day 1 through Month 12
|
Overall Response Rate by Lugano Criteria
Time Frame: Day 28, Month 3, 6, 9, and 12
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Day 28, Month 3, 6, 9, and 12
|
|
Duration of Response
Time Frame: Day 28, Month 3, 6, 9, and 12
|
Day 28, Month 3, 6, 9, and 12
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Progression Free Survival
Time Frame: Day 28, Month 3, 6, 9, and 12
|
Day 28, Month 3, 6, 9, and 12
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Time To Progression
Time Frame: Day 28, Month 3, 6, 9, and 12
|
Day 28, Month 3, 6, 9, and 12
|
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Overall Survival
Time Frame: Day 28, Month 3, 6, 9, and 12
|
Day 28, Month 3, 6, 9, and 12
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Rose Lai, MD, Adicet Bio
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Lymphoma, Follicular
- Lymphoma, B-Cell
- Lymphoma, Large B-Cell, Diffuse
- Lymphoma, Non-Hodgkin
- Lymphoma, Mantle-Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Fludarabine
Other Study ID Numbers
- ADI-20200101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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