A Safety and Efficacy Study of ADI-001, an Anti-CD20 Allogeneic Gamma Delta CAR-T, in Subjects With B Cell Malignancies (GLEAN-1)
Lymphoma, Follicular, Lymphoma, Mantle-Cell, Marginal Zone Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma, Follicular focused on measuring B-cell lymphoma, CAR-T, Cell Therapy, Allogeneic Cell Therapy, T cells, gamma delta, Immunotherapy, Adoptive, Antigens, CD20
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
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)
Sites / Locations
- Stanford University Medical CenterRecruiting
- University of Miami- Sylvester Comprehensive Cancer CenterRecruiting
- Northside Hospital Blood and Marrow Transplant Group of GeorgiaRecruiting
- The State University of IowaRecruiting
- Norton Cancer InstituteRecruiting
- Baylor Scott & White Research InstituteRecruiting
- MD Anderson Cancer CenterRecruiting
- Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
ADI-001 Dose Escalation
ADI-001 Dose Extension
ADI-001 Dose Expansion
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).
ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).
Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).