A Study of ADI-001 in B Cell Malignancies

• Status: Recruiting
• Trial end date: 2024-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Adicet Bio, Inc
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Fludarabine; Interleukin-2

Criteria

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)