CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorSt. Jude Children's Research Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Relapsed disease that is CD70 positive
Refractory disease that is persistent despite 3 cycles of chemotherapy
Patients in 2nd or greater relapse
Patients with relapse after allogeneic HSCT
Disqualifiers
Known primary immunodeficiency
Known history of HIV positivity
Severe intercurrent bacterial, viral or fungal infection
History of hypersensitivity to cornstarch or hydroxyethyl starch
Trial design
Design model
Single group
Treatments tested in this trial
Fludarabine
Drug40mg/m2, Day -4, -3 and -2
Cyclophosphamide
DrugDay -3 and Day-2 REST DAY, -1
CD70-CAR T cell infusion (Autologous)
DrugDay 0 or +1
Mesna
DrugMesna 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
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: CD70- CAR T cell TherapyExperimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
Maximum tolerated dose of CD70-CAR T cells
Phase I design to determine the maximum tolerated dose (MTD) of autologous, CD70-CAR T cells. Three (3) dose levels will be evaluated (1x10e6, 3x10e6, and 1x10e7 cells/kg).
Time frame
28 days after CD70-CAR T-cell infusionSponsors and contacts
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Source ClinicalTrials.gov