Overview

ADI-001 is an investigational immunotherapy composed of allogeneic gamma delta T cells that is being evaluated as a potential treatment for patients diagnosed with B cell malignancies who have relapsed or are refractory to at least two prior regimens. This first-in-human study will assess the safety and tolerability of ADI-001 and is designed to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD). Patients will be administered a single infusion or multiple infusions of ADI-001 cells. The study will include the following two parts: Part 1 : dose escalation and extension. Parts 1a (escalation) and 1b (extension) will involve escalation and administration of single dose of ADI-001 and multiple doses of ADI-001. Part 2 : dose expansion will involve dose administration of ADI-001 at MTD/MAD as determined in Part 1. The study will also assess the pharmacokinetics and pharmacodynamics of ADI-001.

Principal investigator

Umar Farooq
Internal Medicine

Eligibility 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. 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 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
  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)
Show more

Participate in this trial

Are you interested in enrolling in this study? Learn more here.

I'm Interested In Participating

For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Umar Farooq
Enroll your patient