Trial Search Results

A Study of ADI-001 in B Cell Malignancies

This is a phase 1 study, to describe the safety and efficacy of ADI-001, anti-CD20 CAR-enginnered allogeneic gamma T cells, in adultsubjects with B Cell malignancies, in monotherapy and combinationwith IL-2. Part 1 of the study is dose escalation and extension, part2 is dose expansion, and part 3 is ADI-001 combination with IL-2.This study will further research into allogeneic CAR T cell therapyin R/R B cell NHL, while investigating the clinical potential ofgamma delta T cell-based therapies, and further investigating CD20 asan attractive target antigen for immune-based therapies.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Adicet Bio, Inc

Stanford Investigator(s):

Intervention(s):

  • Genetic: ADI-001
  • Drug: Fludarabine
  • Drug: Cyclophosphamide
  • Drug: Bendamustine
  • Drug: Interleukin-2

Phase:

Phase 1

Eligibility


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)

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Benjamin Leung
650-787-1216
Recruiting