← Back to Search

CAR T-cell Therapy

CAR T-Cell Therapy for Acute Myeloid Leukemia

Phase 1
Waitlist Available
Led By Swati Naik, 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
Relapsed/refractory CD123+ disease defined as follows: AML/MDS - Relapsed disease: Patients developing recurrent disease after a first complete remission (CR) Refractory disease: Patients not achieving a CR after 2 cycles of induction chemotherapy B-cell ALL - Relapsed disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies including Patients in 2nd or greater relapse Patients with relapse after allogeneic HSCT Refractory disease that is CD123 positive and CD19 negative/dim or patients otherwise ineligible for CD19 directed therapies T-cell All - Relapsed refractory disease that is CD123 positive BPDCN - Relapsed/refractory disease that has failed front-line therapy Estimated life expectancy of >12 weeks Karnofsky or Lansky (age-dependent) performance score ≥50 Patients with a history of prior allogeneic 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 Patient must have an identified, suitable HCT donor For females of child-bearing age: Not lactating with intent to breastfeed Not pregnant with negative serum pregnancy test within 7 days prior to enrollment Meets eligibility criteria to undergo autologous apheresis, or have previously undergone autologous apheresis
Age ≤21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after cd123-car t-cell infusion
Awards & highlights

Study Summary

This trial is testing a new treatment, CD123-CAR T-cell therapy, for patients with AML/myelodysplastic syndrome (MDS), T- or B- acute lymphoblastic leukemia (ALL) or blastic plasmacytoid dendritic cell neoplasia (BPDCN). The goal is to find the maximum safe dose of CD123-CAR T cells to give to these patients.

Who is the study for?
This trial is for young people (21 or younger) with certain types of leukemia that have come back or didn't respond to treatment. They should be in a condition where they can live at least 12 more weeks, able to do some daily activities, and not pregnant or breastfeeding. They must also have a donor ready for cell therapy.Check my eligibility
What is being tested?
The trial tests CD123-CAR T-cell therapy after chemotherapy to find the highest safe dose. It's given through an IV and aims to see how well it works against leukemia and what side effects it has on patients' bodies, disease control, and survival rates.See study design
What are the potential side effects?
Possible side effects include reactions from the infusion of T-cells, symptoms from the immune system attacking normal cells by mistake (like inflammation), tiredness, nausea, low blood counts increasing infection risk, liver issues, heart problems due to chemo drugs like Cyclophosphamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 21 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after cd123-car t-cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after cd123-car t-cell 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
Maximum tolerated dose of CD123-CAR T cells (CATCHAML)

Trial Design

1Treatment groups
Experimental Treatment
Group I: CD123-CAR T cell therapyExperimental Treatment5 Interventions
CD123-CAR T-cell dose and infusion Up to 4 Dose levels will be evaluated with a maximum dose of 2.5 x 10^8 CAR+ T cells. If dose limiting toxicities (DLTs) are observed on Dose level 1 then the cell dose is de- escalated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine
2012
Completed Phase 3
~1100
Mesna
2003
Completed Phase 2
~1380
Rituximab
1999
Completed Phase 4
~1880

Find a Location

Who is running the clinical trial?

St. Jude Children's Research HospitalLead Sponsor
427 Previous Clinical Trials
5,306,545 Total Patients Enrolled
Swati Naik, MDPrincipal InvestigatorSt. Jude Children's Research Hospital
3 Previous Clinical Trials
10 Total Patients Enrolled
Paulina Velasquez, MDPrincipal InvestigatorSt. Jude Children's Research Hospital

Media Library

CD123-CAR T (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04318678 — Phase 1
Acute Lymphoblastic Leukemia Research Study Groups: CD123-CAR T cell therapy
Acute Lymphoblastic Leukemia Clinical Trial 2023: CD123-CAR T Highlights & Side Effects. Trial Name: NCT04318678 — Phase 1
CD123-CAR T (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318678 — 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 other research studies that have assessed the efficacy of this remedy?

"Currently, 1159 medical studies are active for this treatment and 222 of them have reached Phase 3. Philadelphia is the epicentre of these investigations; however, there are 36802 sites worldwide running trials related to it."

Answered by AI

Has this particular therapy been given a thumbs-up by the FDA?

"The safety of this procedure has been determined to be a 1 due to being in the preliminary Phase 1 trial, implying that there is only limited data available regarding efficacy and security."

Answered by AI

How many participants are actively involved in this medical study?

"Affirmative, the details on clinicaltrials.gov demonstrate that this experiment is currently seeking participants. The trial was initially published on May 27th 2020 and recently modified on May 10th 2022. 32 volunteers are needed from 3 distinct locations to complete this research."

Answered by AI

Are there still opportunities for individuals to participate in this study?

"The trial is currently seeking participants, as per clinicaltrials.gov; the initiation of this medical study was on May 27th 2020 and it has been recently updated on May 10th 2022."

Answered by AI

What medical issue does this treatment typically address?

"This therapeutic intervention is used by physicians to treat lung cancer and other maladies, including multiple sclerosis, b-cell lymphomas, and polyangium."

Answered by AI
~2 spots leftby Jul 2024