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


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Trial ID: NCT04735471


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.

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

Stanford Investigator(s)

David Miklos
David Miklos

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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. Prior Treatment with CD19 CAR T may be considered.

   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. Female patients who are not pregnant or breastfeeding

   8. 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. 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])

   2. 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

      2. Any other acute or chronic medical or psychiatric condition that may increase the
      risk associated with study participation or investigational product

      3. Tumor mass effects such as bowel obstruction or blood vessel compression that
      require therapy

      4. Opportunistic infections

   3. History of any clinically significant conditions in the opinion of the Investigator

   4. 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

   5. Patients unwilling to participate in an extended safety monitoring period (long term
   follow up [LTFU] protocol)


genetic: ADI-001

drug: Fludarabine

drug: Cyclophosphamide


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Benjamin Leung

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