CAR T Cell Therapy for Leukemia

Recruiting at 38 trial locations

Overseen By Autolus Limited

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Autolus Limited

Disqualifiers: CNS pathology, Infections, Hepatitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

153 Participants Needed

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).

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Leukapheresis

Collection of white blood cells from participants to engineer CAR T cells

1 week

Pre-conditioning

Participants undergo pre-conditioning chemotherapy to prepare for CAR T cell infusion

1 week

Treatment

Participants receive a total target dose of 410E+6 CAR T cells as a split dose on Day 1 and Day 10

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AUTO1

Trial Overview The 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

Group I: AUTO1 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Autolus Limited

Lead Sponsor

Trials

9

Recruited

1,000+