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Lymphoma, FollicularPhase 1GLEAN-1NCT04735471

A Phase 1 Study of ADI-001 in B Cell Malignancies

A Phase 1 study testing ADI-001, Fludarabine and Cyclophosphamide in people with Lymphoma, Follicular and Lymphoma, Mantle-Cell, run by Adicet Therapeutics at 10 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a Phase 1 dose escalation 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ADI-001, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
10 sitesUnited States
Study dates
4 Mar 2021to 3 Feb 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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)

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Northside Hospital Blood and Marrow Transplant Group of Georgia

    Atlanta, Georgia, 30342

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75204

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • The State University of Iowa

    Iowa City, Iowa, 52242

  • Norton Cancer Institute

    Louisville, Kentucky, 40207

  • University of Miami- Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Swedish Cancer Center

    Seattle, Washington, 98104

  • Stanford University Medical Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: 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 escalation 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.

Read the 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.

Being tested
ADI-001, Fludarabine, Cyclophosphamide
Keywords
B-cell lymphoma, CAR-T, Cell Therapy, Allogeneic Cell Therapy, T cells, gamma delta, Immunotherapy, Adoptive, Antigens, CD20
Medical subject headings
Lymphoma, Follicular, Lymphoma, Mantle-Cell, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04735471
Study groupRoleWhat they receive
ADI-001 Dose EscalationExperimentalADI-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).
Receives: Genetic: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide
ADI-001 Dose ExtensionExperimentalADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).
Receives: Genetic: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide
ADI-001 Dose ExpansionExperimentalDose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
Receives: Genetic: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

    This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD).

    Measured: Day 28

  2. Proportion of treatment emergent and treatment related adverse events

    This primary endpoint will be used to determine the MTD/MAD of ADI-001

    Measured: 1 year

Secondary outcomes (6)

  1. Frequency and persistence of ADI-001

    Defined as duration from Day 1 to undetectable levels of ADI-001 cells per microliter blood

    Measured: Day 1 through Month 12

  2. Overall Response Rate by Lugano Criteria

    Measured: Day 28, Month 3, 6, 9, and 12

  3. Duration of Response

    Measured: Day 28, Month 3, 6, 9, and 12

  4. Progression Free Survival

    Measured: Day 28, Month 3, 6, 9, and 12

  5. Time To Progression

    Measured: Day 28, Month 3, 6, 9, and 12

  6. Overall Survival

    Measured: Day 28, Month 3, 6, 9, and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2021
  2. Study start4 Mar 2021
  3. Primary completion3 Feb 2025
  4. Study completion3 Feb 2025

Why it stopped: Terminated - Halted Prematurely

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
3+3 Dose Escalation Design
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04735471
Sponsor's protocol ID
ADI-20200101
Acronym
GLEAN-1
Status last verified
Jun 2025
First submitted
26 Jan 2021
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nishimoto KP, Barca T, Azameera A, Makkouk A, Romero JM, Bai L, Brodey MM, Kennedy-Wilde J, Shao H, Papaioannou S, Doan A, Masri C, Hoang NT, Tessman H, Ramanathan VD, Giner-Rubio A, Delfino F, Sharma K, Bray K, Hoopes M, Satpayev D, Sengupta R, Herrman M, Abbot SE, Aftab BT, An Z, Panuganti S, Hayes SM. Allogeneic CD20-targeted gammadelta T cells exhibit innate and adaptive antitumor activities in preclinical B-cell lymphoma models. Clin Transl Immunology. 2022 Feb 2;11(2):e1373. doi: 10.1002/cti2.1373. eCollection 2022.

    PubMed 35136603

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADI-001, Fludarabine and Cyclophosphamide in people with Lymphoma, Follicular and Lymphoma, Mantle-Cell, run by Adicet Therapeutics at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Terminated - Halted Prematurely). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04735471, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.

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