ADI-001 for Non-Hodgkin's Lymphoma
(GLEAN-1 Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are on treatments like gene therapy or certain cell therapies, you may need to wait a few weeks before joining the study.
What data supports the effectiveness of the treatment ADI-001 for Non-Hodgkin's Lymphoma?
Research on similar CAR T cell therapies, like those targeting CD19, shows they can be very effective in treating certain types of blood cancers, including some forms of lymphoma. These therapies have transformed outcomes for patients who did not respond to other treatments, suggesting that ADI-001, which targets CD20, might also be promising for Non-Hodgkin's Lymphoma.12345
What safety information is available for ADI-001 or similar CAR T-cell therapies?
CAR T-cell therapies, like ADI-001, have shown potential in treating certain lymphomas but can have serious side effects. These include cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). While these treatments are promising, managing these side effects is crucial.16789
What makes the drug ADI-001 unique for treating Non-Hodgkin's Lymphoma?
ADI-001 is a novel treatment that uses genetically modified immune cells called CAR-T cells, specifically targeting the CD20 protein on cancer cells, which is different from traditional chemotherapy or radiation therapies. This approach harnesses the body's own immune system to fight the cancer more precisely.1011121314
Research Team
Adicet Medical Director
Principal Investigator
Adicet Bio
Eligibility Criteria
Adults with certain B cell malignancies who've had at least two prior treatments, including anti-CD20 antibody therapies. They must have measurable disease, be in good physical condition (ECOG PS of 0 or 1), and not pregnant or breastfeeding. Participants need to use effective birth control and can't join if they've had CNS lymphoma, recent unrelated cancers, gene therapy within six weeks, radiation within four weeks (except palliative), stem cell transplant within six weeks, or allogeneic transplant within three months.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive ascending doses of ADI-001 to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD)
Dose Extension
Participants receive multiple doses of ADI-001 at the MAD/MTD to evaluate safety
Dose Expansion
Participants receive ADI-001 at the MTD/MAD to confirm the recommended phase 2 dose
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ADI-001
Find a Clinic Near You
Who Is Running the Clinical Trial?
Adicet Therapeutics
Lead Sponsor
Adicet Bio, Inc
Lead Sponsor