NCT04735471: GLEAN-1

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

Terminated Phase 1 Last updated 18 June 2025

What this trial tests

Phase 1 trial testing ADI-001 in Lymphoma, Follicular in 34 participants. Terminated before completion.

Timeline

4 March 2021

Primary endpoint
3 February 2025

3 February 2025

Quick facts

Lead sponsor	Adicet Therapeutics
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	34
Start date	4 March 2021
Primary completion	3 February 2025
Estimated completion	3 February 2025
Sites	10 locations across United States

Drugs / interventions tested

• ADI-001 — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Cyclophosphamide (cyclophosphamide) — full drug profile →

Conditions studied

• Lymphoma, Follicular — all drugs for Lymphoma, Follicular →
• Lymphoma, Mantle-Cell — all drugs for Lymphoma, Mantle-Cell →
• Marginal Zone Lymphoma — all drugs for Marginal Zone Lymphoma →
• Primary Mediastinal B-cell Lymphoma — all drugs for Primary Mediastinal B-cell Lymphoma →

Sponsor

Adicet Therapeutics — full company profile →

Who can join

18 and older, any sex, with Lymphoma, Follicular or Lymphoma, Mantle-Cell. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. γδ T cells: origin and fate, subsets, diseases and immunotherapy.
   Hu Y, Hu Q, Li Y, Lu L, et al · · 2023 · cited 221× · PMID 37989744 · DOI 10.1038/s41392-023-01653-8
2. Off-the-shelf Vδ1 gamma delta T cells engineered with glypican-3 (GPC-3)-specific chimeric antigen receptor (CAR) and soluble IL-15 display robust antitumor efficacy against hepatocellular carcinoma.
   Makkouk A, Yang XC, Barca T, Lucas A, et al · · 2021 · cited 158× · PMID 34916256 · DOI 10.1136/jitc-2021-003441
3. Challenges and new technologies in adoptive cell therapy.
   Zhang P, Zhang G, Wan X. · · 2023 · cited 153× · PMID 37596653 · DOI 10.1186/s13045-023-01492-8
4. Exploiting innate immunity for cancer immunotherapy.
   Yi M, Li T, Niu M, Mei Q, et al · · 2023 · cited 151× · PMID 38008741 · DOI 10.1186/s12943-023-01885-w
5. Gamma Delta T-Cell Based Cancer Immunotherapy: Past-Present-Future.
   Saura-Esteller J, de Jong M, King LA, Ensing E, et al · · 2022 · cited 144× · PMID 35784326 · DOI 10.3389/fimmu.2022.915837
6. Allogeneic CD20-targeted γδ T cells exhibit innate and adaptive antitumor activities in preclinical B-cell lymphoma models.
   Nishimoto KP, Barca T, Azameera A, Makkouk A, et al · · 2022 · cited 83× · PMID 35136603 · DOI 10.1002/cti2.1373
7. Chimeric antigen receptor- and natural killer cell receptor-engineered innate killer cells in cancer immunotherapy.
   Zhang C, Hu Y, Xiao W, Tian Z. · · 2021 · cited 65× · PMID 34267335 · DOI 10.1038/s41423-021-00732-6
8. Natural killer T cells and other innate-like T lymphocytes as emerging platforms for allogeneic cancer cell therapy.
   Courtney AN, Tian G, Metelitsa LS. · · 2023 · cited 59× · PMID 36347021 · DOI 10.1182/blood.2022016201