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Taking people in United StatesPhase 1

CD70 CAR T-cell therapy for children with hard-to-treat blood cancers

Tests CD70 CAR T cells in young people with returning or resistant blood cancers.

Key facts

Who runs it
St. Jude Children's Research Hospital
Where
Memphis, United StatesSee the site
Trial code
Registry title
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Status
Recruiting
Phase
Phase 1
People taking part
18 people, planned
Started
16 Oct 2024
Expected to end
1 Jul 2031
Type of study
Interventional
Treatments tested
  • Fludarabine
  • Cyclophosphamide
  • CD70-CAR T cell infusion (Autologous)
  • Mesna
Record updated
23 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and young adults aged 21 or younger with a blood cancer that is CD70 positive and has come back after treatment or has not responded to treatment.

Age
21 years or younger
Sex
All sexes
Disease stage
CD70-positive AML, MDS, B-cell ALL, T-cell ALL, mixed phenotype acute leukemia or lymphoma that has come back (relapsed) or persists despite 3 cycles of induction chemotherapy (refractory). For B-cell ALL and lymphoma: CD19 negative/dim or otherwise unable to have CD19-directed therapy, such as 2nd or later relapse or relapse after allogeneic HSCT.
Earlier treatment
Refractory disease means persistent disease despite 3 cycles of induction chemotherapy. If a person had an earlier allogeneic stem cell transplant, they must have recovered, have no active GVHD and have had no donor lymphocyte infusion in the 28 days before apheresis. A donor for a stem cell transplant must be identified.
Biomarker or test result
The cancer must be CD70 positive. For B-cell ALL and lymphoma, CD19 negative/dim, or otherwise unable to have CD19-directed therapy.

Main reasons for not taking part

  • Known primary immunodeficiency
  • Known history of HIV positivity
  • Severe infection with bacteria, viruses or fungi
  • Acute promyelocytic leukemia (APL)
  • Known reason that rules out fludarabine/cyclophosphamide chemotherapy

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • Age ≤21 years old
  • Relapsed/refractory CD70+ hematological malignancy
  • Relapsed disease: Patients developing recurrent disease after a prior complete remission (CR)
  • Refractory disease: Patients with persistent disease despite 3 cycles of induction chemotherapy
  • Relapsed/refractory CD70+ AML or MDS:; Relapsed disease that is CD70 positive; Refractory disease that is persistent despite 3 cycles of chemotherapy
  • Relapsed/refractory CD70+ B-cell ALL:; Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:; Patients in 2nd or greater relapse; Patients with relapse after allogeneic HSCT
  • Relapsed/refractory CD70+ T-cell ALL:; Relapsed /refractory disease that is CD70 positive
  • Mixed Phenotype Acute Leukemia (MPAL):; Relapsed/refractory that is CD70 positive
  • Relapsed/refractory CD70+ lymphoma:; Relapsed disease that is CD70 positive and CD19 negative/dim or patients otherwise ineligible for CD19-directed therapies including:; Patients in 2nd or greater relapse; Patients with relapse after allogeneic HSCT; Estimated life expectancy of >12 weeks; Karnofsky or Lansky (age- dependent) performance score ≥50; Patients with a history of prior allogeneic HCT must be clinically recovered from prior HCT therapy, have no evidence of active GVHD and have not received a donor lymphocyte infusion (DLI) within the 28 days prior to apheresis; Patient must have an identified HCT donor; For females of childbearing age:
  • Not lactating with intent to breastfeed
  • Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment

Who cannot take part

  • chemotherapy regimen of Fludarabine/cyclophosphamide
  • Known history of HIV positivity
  • Severe intercurrent bacterial, viral or fungal infection
  • History of hypersensitivity to cornstarch or hydroxyethyl starch
  • Known primary immunodeficiency
  • Patients with acute promyelocytic leukemia (APL)
  • Known contraindication to protocol defined lymphodepleting

Where in United States

  • St. Jude Children's Research HospitalMemphis, United StatesContact: Swati Naik, MDTaking people

About the trial

What the trial wants to find out

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).

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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.

The group in the trial

  • CD70- CAR T cell TherapyTreatment being tested

    Patients will receive autologous (their own) cells.

    Treatment: Fludarabine, Cyclophosphamide, CD70-CAR T cell infusion (Autologous), and Mesna

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Plain-language title
CD70 CAR T-cell therapy for children with hard-to-treat blood cancersGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
23 January 2026