RightFit
RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "The primary interventions are a lymphodepleting chemotherapy regimen (fludarabine and cyclophosphamide), followed by a single autologous infusion of CD70-CAR T cells."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official 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 * 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 sites (1)

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