T-APCs after CAR T Therapy for Leukemia

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Seattle Children's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.

Eligibility Criteria

This trial is for people with CD19+ leukemia that came back or didn't respond to treatment, but are now in remission after CAR-T cell therapy. They must have good kidney, liver, heart, and lung function; a decent number of lymphocytes; no HIV or hepatitis B/C; be able to handle apheresis (a procedure to collect blood cells); and not have serious brain issues, other active cancers, or recent treatments for graft-versus-host disease.

Inclusion Criteria

I am generally healthy and active.

My kidney, liver, heart, and lung functions are all good.

HIV negative

+4 more

Exclusion Criteria

I have significant brain function issues.

I have an active cancer that is not CD19 positive.

I have active GVHD or have been on GVHD treatment in the last 4 weeks.

Participant Groups

The study is testing if giving T-cell Antigen Presenting Cells (T-APCs) after CAR-T cell therapy can make the CAR-T cells last longer and prevent leukemia from coming back. Patients who've had success with initial CAR-T treatment will receive these additional T-APCs at set times.

4Treatment groups

Experimental Treatment

Group I: Cohort DExperimental Treatment1 Intervention

Participants will receive CD19-targeting CAR T cells. Participants who do not meet assignment rules for Cohorts A, B, or C will be followed after CAR T cell infusion in Cohort D.

Group II: Cohort CExperimental Treatment1 Intervention

Participants will receive CD19-targeting CAR T cells. Participants for whom laboratory testing shows loss of CAR T cells within 6 months will be assigned to Cohort C. They will receive another CAR T cell infusion followed by up to 6 T-APC treatments.

Group III: Cohort BExperimental Treatment1 Intervention

Participants will receive CD19-targeting CAR T cells. Participants for whom laboratory testing on Study Day 14 indicates they are at risk for early loss of CAR T cells will be assigned to Cohort B to receive up to 6 T-APC treatments. If laboratory testing prior to planned T-APC treatment indicates loss of CAR-T cells, participants may move to Cohort C.

Group IV: Cohort AExperimental Treatment1 Intervention

Participants will receive CD19-targeting CAR T cells. Participants who have a total CD19 antigen load in bone marrow of \<15% will be assigned to Cohort A, to receive up to 6 T-APC treatments.