RecruitingPhase 1NCT06326463

CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies


Sponsor

St. Jude Children's Research Hospital

Enrollment

18 participants

Start Date

Oct 16, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study participant has one of the following blood cancers: acute myelogenous leukemia (AML)/myelodysplastic syndrome (MDS), acute lymphoblastic leukemia (B-ALL, T-ALL) or Lymphoma. Your cancer has been difficult to treat (refractory) or has come back after treatment (relapse). Primary Objective To determine the safety and maximum tolerated dose of intravenous infusions of escalating doses of CD70-CAR T cells in patients (≤21 years) with recurrent/refractory CD70+ hematological malignancies after lymphodepleting chemotherapy. Secondary Objectives To evaluate the antileukemic activity of CD70-CAR T cells. We will determine the anti- leukemic activity of the CD70-CAR T cells in the bone marrow and in the treatment of extramedullary disease.


Eligibility

Max Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new CAR T-cell therapy targeting a protein called CD70 for children and young adults with blood cancers (like AML, MDS, or ALL) that have come back after treatment or stopped responding. CAR T-cell therapy engineers immune cells to hunt down and destroy cancer cells that carry a specific marker — in this case, CD70. **You may be eligible if...** - You are 21 years old or younger - You have a CD70-positive blood cancer that has relapsed or is refractory (not responding to chemo) - For B-cell ALL: your cancer no longer expresses CD19 (making standard CD19-targeted therapies ineffective), or you are in 2nd or greater relapse - For T-cell ALL or AML/MDS: your cancer is CD70-positive and has returned after multiple treatments or transplant **You may NOT be eligible if...** - Your cancer does not express CD70 - You have uncontrolled infections or organ failure - You do not meet health thresholds for participating in an experimental therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFludarabine

40mg/m2, Day -4, -3 and -2

DRUGCyclophosphamide

Day -3 and Day-2 REST DAY, -1

DRUGCD70-CAR T cell infusion (Autologous)

Day 0 or +1

DRUGMesna

Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide


Locations(1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

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NCT06326463


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