Recruiting
Phase 1

CAR T-Cell Therapy

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06326463

Conditions

Hematologic Malignancy

ALL, Childhood

AML, Childhood

Lymphoma

MDS

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Interventions

Fludarabine

Cyclophosphamide

CD70-CAR T cell infusion (Autologous)

Mesna

Study Details

Brief 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.

Conditions

Hematologic Malignancy

ALL, Childhood

AML, Childhood

Lymphoma

MDS

Study ID

NCT06326463

Start date

Oct 16, 2024

Status verified date

Jan, 2026

Completion date

Jul 1, 2031

Anticipated

Primary completion date

Jul 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 21

Healthy Volunteers: Not accepted

Inclusion Criteria

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:

i. Not lactating with intent to breastfeed

ii. Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment

Exclusion Criteria

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

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CD70- CAR T cell Therapy

Patients will receive autologous (their own) cells.

Interventions

Fludarabine

40mg/m2, Day -4, -3 and -2

Cyclophosphamide

Day -3 and Day-2

REST DAY, -1

CD70-CAR T cell infusion (Autologous)

Day 0 or +1

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Swati Naik, MBBS

866-278-5833referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Swati Naik, MD

866-278-5833referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-01-23.