CAR T Cell Therapy for Leukemia

Recruiting in Palo Alto (17 mi)

+38 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Autolus Limited

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase Ib/II study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (ALL).

Research Team

Eligibility Criteria

Adults over 18 with B cell acute lymphoblastic leukemia that's come back or hasn't responded to treatment. They must have a certain level of cancer cells in their bone marrow, be relatively healthy (ECOG status 0 or 1), and not have severe infections or other specific blood diseases. People with heart, liver, kidney, or lung problems can't join.

Inclusion Criteria

My kidney, liver, lung, and heart functions are all within normal ranges.

Phase Ib: Primary Cohort IA: Presence of ≥5% blasts in BM at screening

I am in my 2nd or later complete remission, with minimal disease detected and less than 5% cancer cells in my bone marrow.

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Exclusion Criteria

I am currently fighting an infection that needs strong medication.

I have had CD19 therapy but not blinatumomab, or I had severe side effects from blinatumomab.

I have been diagnosed with Burkitt's leukemia/lymphoma or CML in blast crisis.

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Treatment Details

Interventions

AUTO1 (CAR T-cell Therapy)

Trial OverviewThe trial is testing AUTO1, a CAR T cell therapy designed to target CD19 on cancer cells in adults with relapsed/refractory B-ALL. It aims to see how safe it is and how well it works at different stages of the disease.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AUTO1Experimental Treatment1 Intervention