A Phase 1 Study of ADI-001 in B Cell Malignancies
Stopped early · Phase 1
Conditions studied: Lymphoma, Follicular, Lymphoma, Mantle-Cell, Marginal Zone Lymphoma, Primary Mediastinal B-cell Lymphoma, Diffuse Large B Cell Lymphoma, Lymphoma, Non-Hodgkin
In brief
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.
Key facts
- Study ID
- NCT04735471
- Run by
- Adicet Therapeutics
- People needed
- 34
- Starts
- 2021-03-04
- Expected to finish
- 2025-02-03
- Last updated by the study team
- 2025-06-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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)
Where it is running
- Stanford University Medical Center — Stanford, California, United States
- University of Miami- Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Northside Hospital Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
- The State University of Iowa — Iowa City, Iowa, United States
- Norton Cancer Institute — Louisville, Kentucky, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Baylor Scott & White Research Institute — Dallas, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Swedish Cancer Center — Seattle, Washington, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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