ALLO-647 + CAR T Cell Therapy for Large B-Cell Lymphoma
(EXPAND Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Allogene Therapeutics

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma

Research Team

Eligibility Criteria

This trial is for adults with large B-cell lymphoma that has come back or hasn't responded to treatment. Participants must have had at least two prior chemotherapy treatments, be in good physical condition (ECOG status 0 or 1), and not have immune reactions against donor cells. They can't join if they've had a bone marrow transplant in the last six months or cancer affecting their central nervous system.

Inclusion Criteria

My condition did not improve after 2 chemotherapy treatments.

My blood, kidney, and liver tests are within normal ranges.

Absence of significant donor (product)-specific anti-HLA antibodies (DSA)

See 2 more

Exclusion Criteria

I had a stem cell transplant within the last 6 months.

My cancer has spread to my brain or spinal cord.

My bone marrow is less active than normal for my age.

Treatment Details

Interventions

ALLO-501A (CAR T-cell Therapy)
ALLO-647 (Lymphodepleting Agent)

Trial OverviewThe EXPAND study is testing whether adding ALLO-647 to the usual drugs fludarabine and cyclophosphamide helps improve outcomes when given before CAR T cell therapy (ALLO-501A) in patients whose large B-cell lymphoma has relapsed or is resistant to treatment.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Lymphodepletion with fludarabine and cyclophosphamideExperimental Treatment3 Interventions

ALLO-501A CAR T cells infused following lymphodepletion

Group II: Lymphodepletion with ALLO-647, fludarabine, and cyclophosphamideExperimental Treatment4 Interventions

ALLO-501A CAR T cells infused following lymphodepletion