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
Qualifiers
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
Treatments tested in this trial
- Fludarabine
- Cyclophosphamide
- CD70-CAR T cell infusion (Autologous)
- Mesna
Treatment groups
18 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov