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A Study of ADI-001 in B Cell Malignancies (GLEAN-1)

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ClinicalTrials.gov Identifier: NCT04735471
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : June 4, 2021
Sponsor:
Information provided by (Responsible Party):
Adicet Bio, Inc

Tracking Information
First Submitted Date  ICMJE January 26, 2021
First Posted Date  ICMJE February 3, 2021
Last Update Posted Date June 4, 2021
Actual Study Start Date  ICMJE March 4, 2021
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • 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 optimal dose.
  • Proportion of treatment emergent and treatment related adverse events [ Time Frame: 1 year ]
    This primary endpoint will be used to determine the optimal dose of ADI-001
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2021)
  • Duration of ADI-001 persistence [ Time Frame: Day 1 through Month 12 ]
    Defined as duration from Day 1 to undetectable levels of ADI-001 cells per microliter blood
  • Overall Response Rate by Lugano Criteria [ Time Frame: Day 28, Month 3, 6, 9, and 12 ]
  • Duration of Response by Lugano Criteria [ Time Frame: Day 28, Month 3, 6, 9, and 12 ]
  • Progression Free Survival by Lugano Criteria [ Time Frame: Day 28, Month 3, 6, 9, and 12 ]
  • Time To Progression by Lugano Criteria [ Time Frame: Day 28, Month 3, 6, 9, and 12 ]
  • Overall Survival by Lugano Criteria [ Time Frame: Day 28, Month 3, 6, 9, and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of ADI-001 in B Cell Malignancies
Official Title  ICMJE A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta T Cells in Adults With B Cell Malignancies, in Monotherapy and Combination With IL 2
Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ADI-001 in patients with B cell malignancies. Study details include:

Study Duration: 2 years (1 year of enrollment and 1 year of study participation) Treatment Duration: ADI-001:1 day (single dose); IL-2 (Part 3 only): 14 days Visit Frequency: Daily for 8 days, then Day 10, 12, 14, 21, 28, and Month 3, 6, 9, and 12

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 optimal dose. Patients will be administered a single infusion of ADI-001 cells. A combination of ADI-001 and interleukin (IL)-2 may also be evaluated after the MTD or optimal dose has been determined for the single agent.

The study will also assess the pharmacokinetics and pharmacodynamics of ADI-001.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
3+3 Factorial Design
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
  • Marginal Zone Lymphoma
  • Lymphoma, Burkitt
  • Mediastinal Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse
Intervention  ICMJE
  • Genetic: ADI-001
    Anti-CD20 CAR-T
  • Drug: Fludarabine
    Chemotherapy for Lymphodepletion
  • Drug: Cyclophosphamide
    Chemotherapy for Lymphodepletion
  • Drug: Bendamustine
    Chemotherapy for Lymphodepletion
  • Drug: Interleukin-2
    To support growth and activation of ADI-001
Study Arms  ICMJE
  • Experimental: ADI-001 Dose Escalation
    ADI-001 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) or optimal ADI-001 dose (Part 1).
    Interventions:
    • Genetic: ADI-001
    • Drug: Fludarabine
    • Drug: Cyclophosphamide
    • Drug: Bendamustine
  • Experimental: ADI-001 Dose Expansion
    ADI-001 is administered via infusion to 3 NHL subtypes to confirm dose (Part 2).
    Interventions:
    • Genetic: ADI-001
    • Drug: Fludarabine
    • Drug: Cyclophosphamide
    • Drug: Bendamustine
  • Experimental: ADI-001 in combination with Interleukin-2
    ADI-001 is administered via infusion in combination with subcutaneously administered IL-2 (Part 3).
    Interventions:
    • Genetic: ADI-001
    • Drug: Fludarabine
    • Drug: Cyclophosphamide
    • Drug: Bendamustine
    • Drug: Interleukin-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2021)
76
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2024
Estimated Primary Completion Date March 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  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. Resolved toxicities of any prior therapy to either baseline or CTCAE grade 1 (version 5.0)
  8. Female patients who are not pregnant or breastfeeding
  9. 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. Known CD20-negative B cell lymphoma at time of initial diagnosis
  2. 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])
  3. 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
  4. History of any clinically significant conditions in the opinion of the Investigator, including, but not limited to:

    1. Infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of ADI 001
    2. Any form of primary immunodeficiency such as severe combined immunodeficiency disease
    3. Cardiovascular conditions (Class III or IV heart failure as defined by the New York Heart Association [NYHA], cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease) within the past 6 months
    4. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura within the 4 weeks prior to first dose of ADI 001 or the need for daily prednisone greater than 5 mg (or corticosteroid equivalent) to control an autoimmune disease
    5. Severe immediate hypersensitivity reaction to any of the agents used in this study
  5. 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. Exception: Prior therapy with approved anti-CD19 CAR T cell products is allowed.

    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 stem cell transplant and donor lymphocyte infusion within 3 months of planned CAR T cell infusion

  6. Patients unwilling to participate in an extended safety monitoring period (long term follow up [LTFU] protocol)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peg Taylor (650) 850-8020 clinicaltrials@adicetbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04735471
Other Study ID Numbers  ICMJE ADI-20200101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adicet Bio, Inc
Study Sponsor  ICMJE Adicet Bio, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rose Lai, MD Adicet Bio
PRS Account Adicet Bio, Inc
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP