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

NCT04735471 | Terminated Phase 1 FDA Drug

• 1 other identifier: ADI-20200101
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Lymphoma, Follicular; Lymphoma, Mantle-Cell; Marginal Zone Lymphoma; Primary Mediastinal B-cell Lymphoma; Diffuse Large B Cell Lymphoma; Lymphoma, Non-Hodgkin

Keywords

B-cell lymphoma; CAR-T; Cell Therapy; Allogeneic Cell Therapy; T cells, gamma delta; Immunotherapy, Adoptive; Antigens, CD20

Outcome Measures

Primary Outcomes (2)

• 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).

  Day 28

• Proportion of treatment emergent and treatment related adverse events

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

  1 year

Secondary Outcomes (6)

• Frequency and persistence of ADI-001

  Day 1 through Month 12

• Overall Response Rate by Lugano Criteria

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

• Duration of Response

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

• Progression Free Survival

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

• Time To Progression

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

Study Arms (3)

ADI-001 Dose Escalation

EXPERIMENTAL

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).

Genetic: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide

ADI-001 Dose Extension

EXPERIMENTAL

ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).

Genetic: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide

ADI-001 Dose Expansion

EXPERIMENTAL

Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Genetic: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide

Interventions

ADI-001 GENETIC

Anti-CD20 CAR-T

ADI-001 Dose Escalation; ADI-001 Dose Expansion; ADI-001 Dose Extension

Fludarabine DRUG

Chemotherapy for Lymphodepletion

ADI-001 Dose Escalation; ADI-001 Dose Expansion; ADI-001 Dose Extension

Cyclophosphamide DRUG

Chemotherapy for Lymphodepletion

ADI-001 Dose Escalation; ADI-001 Dose Expansion; ADI-001 Dose Extension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Adicet Therapeutics: lead

Study Sites (10)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Miami- Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Northside Hospital Blood and Marrow Transplant Group of Georgia

Atlanta, Georgia, 30342, United States

Location

The State University of Iowa

Iowa City, Iowa, 52242, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75204, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Swedish Cancer Center

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Publications (1)

• 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.

  PMID: 35136603 DERIVED

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Adicet Medical Director

  Adicet Bio

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3+3 Dose Escalation Design

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 3, 2021
• Study Start: March 4, 2021
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)