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CAR T-cell Therapy

CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

Phase 1 & 2
Waitlist Available
Led By Aimee C. Talleur, MD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CD19+ ALL with any of the following: Minimal Residual Disease (MRD) ≥ 1% at end of up-front induction therapy, Hypodiploid (< 44 chromosomes or < 0.95 DNA index) CD19+ ALL with detectable disease at the end of up-front induction therapy, Increase in disease burden any time after the completion of up-front induction therapy, Primary refractory disease despite at least 2 cycles of an intensive chemotherapy regimen designed to induce remission, Refractory disease despite salvage therapy, 1st or greater relapse, Estimated life expectancy of > 12 weeks, Karnofsky or Lansky (age-dependent) performance score ≥ 50, Patients with a history of prior allogeneic hematopoietic cell transplantation [HCT] must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis
Age ≤ 21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks post-sjcar19 infusion
Awards & highlights

Study Summary

This trial is for patients with relapsed or refractory CD19+ acute lymphoblastic leukemia (ALL) who are between the ages of 0 and 30. The trial will test the safety and effectiveness of a new treatment called chimeric antigen receptor (CAR) T cell therapy. In this therapy, patient's own immune cells are collected and then manufactured to be more effective at killing cancer cells. The product will be made at the St. Jude Children's Research Hospital's Good Manufacturing Practice (GMP) facility. The trial will test different doses of the therapy to find the largest safe dose, as well as how long the therapy lasts in the

Who is the study for?
This trial is for young people (≤21 years old) with a specific type of leukemia called CD19+ ALL that hasn't responded to other treatments or has come back. They should have a life expectancy over 8 weeks, be able to perform certain physical activities, and not be pregnant or breastfeeding. They must agree to use birth control and can't join if they have severe infections, HIV, CNS-3 disease with neurological changes, are on high-dose steroids or immunosuppressants.Check my eligibility
What is being tested?
The study tests CAR T-cell therapy using engineered immune cells (SJCAR19 product) in children and young adults with relapsed/refractory leukemia. It aims to find the highest safe dose, how long these cells last in the body, their side effects, and effectiveness against this type of leukemia.See study design
What are the potential side effects?
Possible side effects include reactions related to immune system activation such as fever and fatigue; organ inflammation; allergic reactions due to mouse protein content in the treatment; blood cell count changes; infection risk increase; and potential neurologic symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 21 years old or younger.
Select...
You have a type of leukemia called CD19+ ALL and have one or more of the following: your cancer has not responded to at least two rounds of chemotherapy, your cancer has not responded to additional treatment after previous attempts, your cancer has relapsed multiple times, you have relapsed after a bone marrow transplant, you need a bone marrow transplant but are not eligible, you are under 21 years old, you have a good performance score, you are expected to live for at least 12 more weeks, you are eligible for or have already undergone apheresis.
Select...
You have a type of leukemia called CD19+ ALL and meet any of the following conditions: your disease has not responded to the usual chemotherapy treatments, you have relapsed multiple times, you have failed to respond to other treatments or you are unable to undergo a stem cell transplant. You are under 21 years old and have a life expectancy of at least 8 weeks. You also need to meet certain health criteria such as having adequate heart, kidney, and lung function, and normal blood count levels. Women who may become pregnant must have a negative pregnancy test and agree to use birth control during and after treatment. Your cancer cells must have certain characteristics for you to be eligible for this study. You must also agree to long-term follow-up.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks post-sjcar19 infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks post-sjcar19 infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complete Response Rate
Maximum Tolerated Dose and Dose-limiting Toxicities

Trial Design

1Treatment groups
Experimental Treatment
Group I: SJCAR19 TherapyExperimental Treatment5 Interventions
Patients in both the Phase I and Phase II portion of the study will receive lymphodepleting chemotherapy (unless determined by PI that lymphodepletion is not necessary), followed by a single infusion of the patient-derived SJCAR19 cellular product. The most commonly used lymphodepleting chemotherapy regimen will consist of the agents: Fludarabine and Cyclophosphamide. They will also receive Mesna. Dosing of SJCAR19 on the Phase I study will follow a dose escalation schema, with dose changes based on dose-limiting toxicities. In the Phase II study, SJCAR19 dosing with follow the maximum tolerated dose, as determined in the Phase I portion. Cells for infusion are prepared using the CliniMACS System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1090
Mesna
2003
Completed Phase 2
~1380
CliniMACS
2005
Completed Phase 3
~770

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
426 Previous Clinical Trials
5,306,579 Total Patients Enrolled
Aimee C. Talleur, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
1 Previous Clinical Trials
60 Total Patients Enrolled

Media Library

SJCAR19 product (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03573700 — Phase 1 & 2
Acute Lymphoblastic Leukemia Research Study Groups: SJCAR19 Therapy
Acute Lymphoblastic Leukemia Clinical Trial 2023: SJCAR19 product Highlights & Side Effects. Trial Name: NCT03573700 — Phase 1 & 2
SJCAR19 product (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03573700 — Phase 1 & 2

Frequently Asked Questions

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

Has prior research been conducted utilizing SJCAR19 product, which is a CD19-specific CAR engineered autologous T-cell?

"Currently, 893 clinical trials related to CD19- specific CAR engineered autologous T-cells (SJCAR19 product) are being conducted worldwide. Of these studies, 161 have progressed to Phase 3. Philadelphia is the primary region hosting such trials but 28460 locations across the globe are running similar research projects."

Answered by AI

Is there an opportunity to participate in the current iteration of this research?

"Affirmative. According to clinicaltrials.gov, this medical experiment is recruiting participants and was initially posted on July 24th 2018; moreover, the listing was recently revised on November 10th 2022. The study requires 35 individuals from 1 site for enrolment."

Answered by AI

What is the aggregate enrollment rate for this investigation?

"Affirmative, clinicaltrials.gov reports that this trial is actively recruiting participants as of now. It was initially posted on the 24th July 2018 and last updated on 10th November 2022. 35 patients are being sought from 1 medical centre."

Answered by AI

What indications is SJCAR19 product, a CD19-specific CAR engineered autologous T-cell therapy, employed to address?

"A variety of maladies, including multiple sclerosis, acute myelocytic leukemia and retinoblastoma can be treated with the SJCAR19 product; a CD19-specific CAR engineered autologous T-cell."

Answered by AI
~4 spots leftby Mar 2025