ADI-001 for Non-Hodgkin's Lymphoma

(GLEAN-1 Trial)

Recruiting in Palo Alto (17 mi)

+11 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Adicet Therapeutics

No Placebo Group

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.

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

My B cell cancer has returned or didn't respond to treatment.

I am 18 years old or older.

I am fully active or can carry out light work.

Exclusion Criteria

Opportunistic infections

I am willing to participate in long-term follow-up for safety monitoring.

I have or had lymphoma in my brain or spinal cord.

Treatment Details

Interventions

• ADI-001 (CAR T-cell Therapy)

Trial Overview The trial is testing ADI-001 combined with Fludarabine and Cyclophosphamide in patients with various types of B-cell lymphomas. It's a Phase 1 study using a '3+3' design to find the safest dose that also works effectively against the cancer.

Participant Groups

Group I: ADI-001 Dose Extension Experimental Treatment 3 Interventions

ADI-001 is administered via infusion at MAD/MTD to evaluate the safety of multiple doses (Part 1b).

Group II: ADI-001 Dose Expansion Experimental Treatment 3 Interventions

Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Group III: ADI-001 Dose Escalation Experimental Treatment 3 Interventions

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).

Who Is Running the Clinical Trial?

Adicet Therapeutics

Lead Sponsor

Trials

4

Recruited

370+

Adicet Bio, Inc

Lead Sponsor

Trials

3

Recruited

310+