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CAR T-cell Therapy

T-APCs after CAR T Therapy for Leukemia

Q: Are there any currently available spots for participants in this clinical trial?

At this time, the trial on clinicaltrials.gov is not accepting participants - it was first posted in August 2017 and last updated March 2022. However, there are still 1,412 other studies that are currently recruiting patients.

Q: Does my health profile meet the qualifications for this clinical research?

The requirements for enrolment in this leukemic trial are that the patient must be between one year and thirty years old. To date, 30 individuals have been recruited to participate.

Q: Has the FDA given sanction to T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)?

Due to the limited amount of existing clinical data, T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC) received a score of 1 in our safety assessment. This is due to its Phase 1 trial status.

Q: Is participation in this research restricted to those beyond the age of 65?

This medical trial has a lower age limit of 1 year and an upper age bound of 30 years.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor

301 Previous Clinical Trials

5,216,947 Total Patients Enrolled

Colleen Annesley, MDStudy ChairSeattle Children's Hospital

3 Previous Clinical Trials

261 Total Patients Enrolled

Media Library

CD19 CAR-T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03186118 — Phase 1

Acute Lymphoblastic Leukemia Research Study Groups: Cohort D, Cohort A, Cohort C, Cohort B

Acute Lymphoblastic Leukemia Clinical Trial 2023: CD19 CAR-T cells Highlights & Side Effects. Trial Name: NCT03186118 — Phase 1

CD19 CAR-T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03186118 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any currently available spots for participants in this clinical trial?

"At this time, the trial on clinicaltrials.gov is not accepting participants - it was first posted in August 2017 and last updated March 2022. However, there are still 1,412 other studies that are currently recruiting patients."

Answered by AI

Does my health profile meet the qualifications for this clinical research?

"The requirements for enrolment in this leukemic trial are that the patient must be between one year and thirty years old. To date, 30 individuals have been recruited to participate."

Answered by AI

Has the FDA given sanction to T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)?

"Due to the limited amount of existing clinical data, T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC) received a score of 1 in our safety assessment. This is due to its Phase 1 trial status."

Answered by AI