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CAR T-cell Therapy

T-APCs after CAR T Therapy for Leukemia

Phase 1

Waitlist Available

Research Sponsored by Seattle Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of recurrent or refractory CD19+ leukemia

Be younger than 65 years old

Must not have

Evidence of active GVHD, or on immunosuppressive GVHD therapy within 4 weeks prior to enrollment

Evidence of active clinically significant CNS dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether giving T-APCs after CAR-T cell treatment can help the CAR-T cells last longer in the body and prevent leukemia from coming back.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here but could include reactions related to immune system activation such as fever, fatigue, headache or more severe complications like neurologic symptoms depending on how patients' bodies react to the new T-APCs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia has come back or is not responding to treatment and tests positive for CD19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have significant brain function issues.

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I have an active cancer that is not CD19 positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the feasibility of deriving and administering a CD19t T-APC product

The adverse events associated with one or multiple CD19t T-APC product infusions will be assessed.

Secondary study objectives

Duration of B cell aplasia in CD19t T-APC treated patients

Quantification of changes in the number of CAR T cells in peripheral blood before and after receiving CD19t T-APCs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 4Eligibility criteria met