Myelodysplastic Syndrome Clinical Trial

CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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

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 is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT06326463

Recruitment Status:

Not yet recruiting

Sponsor:

St. Jude Children's Research Hospital

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There is 1 Location for this study

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St. Jude Children's Research Hospital
Memphis Tennessee, 38105, United States More Info
Swati Naik, MD
Contact
866-278-5833
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Myelodysplastic Syndrome

Phase:

Phase 1

Estimated Enrollment:

24

Study ID:

NCT06326463

Recruitment Status:

Not yet recruiting

Sponsor:


St. Jude Children's Research Hospital

How clear is this clinincal trial information?

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