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

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06326463
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • ALL, Childhood
  • AML, Childhood
  • Hematologic Malignancy
  • Lymphoma
  • MDS

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    40mg/m2, Day -4, -3 and -2
  • Cyclophosphamide — DRUG
    Day -3 and Day-2 REST DAY, -1
  • CD70-CAR T cell infusion (Autologous) — DRUG
    Day 0 or +1
  • Mesna — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 16, 2024
Status verified
Jan 2026
Primary completion
Jul 1, 2030
Completion
Jul 1, 2031

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD70- CAR T cell Therapy
    Patients will receive autologous (their own) cells.

Primary Outcome Measure

Maximum tolerated dose of CD70-CAR T cells [ Time Frame: 28 days after CD70-CAR T-cell infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
Swati Naik, MD
[email protected]
866-278-5833

Find similar trials in Memphis, TN

By research site
St. Jude Children's Research Hospital· Memphis, TN

Related Studies