Status:
TERMINATED
A Phase 1 Study of ADI-001 in B Cell Malignancies
Lead Sponsor:
Adicet Therapeutics
Conditions:
Lymphoma, Follicular
Lymphoma, Mantle-Cell
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
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 relapse...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04735471
Start Date
March 4 2021
End Date
February 3 2025
Last Update
June 18 2025
Active Locations (10)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
University of Miami- Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
3
Northside Hospital Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, United States, 30342
4
The State University of Iowa
Iowa City, Iowa, United States, 52242