Trials / Recruiting
RecruitingNCT06326463
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- St. Jude Children's Research Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary interventions are a lymphodepleting chemotherapy regimen (fludarabine and cyclophosphamide), followed by a single autologous infusion of CD70-CAR T cells. Phase I study evaluating three (3) dose levels of CD70-CAR T cells.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine | 40mg/m2, Day -4, -3 and -2 |
| DRUG | Cyclophosphamide | Day -3 and Day-2 REST DAY, -1 |
| DRUG | CD70-CAR T cell infusion (Autologous) | Day 0 or +1 |
| DRUG | Mesna | 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 |
Timeline
- Start date
- 2024-10-16
- Primary completion
- 2030-07-01
- Completion
- 2031-07-01
- First posted
- 2024-03-22
- Last updated
- 2026-01-23
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06326463. Inclusion in this directory is not an endorsement.