A Safety and Efficacy Study of ADI-001, an Anti-CD20 Allogeneic Gamma Delta CAR-T, in Subjects With B Cell Malignancies (GLEAN-1)

March 10, 2023 updated by: Adicet Bio, Inc

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

This is a Phase 1 dose esclation study following a 3+3 study design. The purpose of this study is to evaluate the safety and efficacy of ADI-001 in patients with B cell malignancies.

Study Overview

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

Interventional

Enrollment (Anticipated)

78

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Contact:
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami- Sylvester Comprehensive Cancer Center
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Northside Hospital Blood and Marrow Transplant Group of Georgia
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kentucky
      • Louisville, Kentucky, United States, 40207
    • Texas
      • Dallas, Texas, United States, 75204
      • Houston, Texas, United States, 77030
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Relapsed/refractory (R/R) previously treated B cell malignancies.
  2. Prior treatment must include at least 2 prior regimens, including anti CD20 antibody therapies. Prior Treatment with CD19 CAR T may be considered.
  3. Documented measurable disease as defined by Lugano 2014
  4. Male or female ≥ 18 years of age
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  6. Adequate hematological, renal, pulmonary, cardiac, and liver function
  7. Female patients who are not pregnant or breastfeeding
  8. 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:

  1. Current or history of any of the following conditions:

    1. Central nervous system (CNS) primary lymphoma (current or history)
    2. Unrelated malignancy requiring systemic treatment (current or history [in the past 3 years, other than hormonal treatment which is allowed])
  2. Any of the following current conditions:

    1. 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
    2. Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration
    3. Tumor mass effects such as bowel obstruction or blood vessel compression that require therapy
    4. Opportunistic infections
  3. History of any clinically significant conditions in the opinion of the Investigator
  4. 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

  5. Patients unwilling to participate in an extended safety monitoring period (long term follow up [LTFU] protocol)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
Progression Free Survival
Time Frame: Day 28, Month 3, 6, 9, and 12
Day 28, Month 3, 6, 9, and 12
Time To Progression
Time Frame: Day 28, Month 3, 6, 9, and 12
Day 28, Month 3, 6, 9, and 12
Overall Survival
Time Frame: Day 28, Month 3, 6, 9, and 12
Day 28, Month 3, 6, 9, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Rose Lai, MD, Adicet Bio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2021

Primary Completion (Anticipated)

March 31, 2023

Study Completion (Anticipated)

March 31, 2024

Study Registration Dates

First Submitted

January 26, 2021

First Submitted That Met QC Criteria

January 28, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2023

Last Update Submitted That Met QC Criteria

March 10, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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