NCT06326463RecruitingPhase 1
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- First submitted
- 15 Mar 2024
- Start date
- 16 Oct 2024
- Primary completion date
- 1 Jul 2030
- Lead sponsor
- St. Jude Children's Research Hospital
- NCT number
- NCT06326463
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 18
- From 16 Oct 2024 to the primary completion date, 1 Jul 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- chemotherapy regimen of Fludarabine/cyclophosphamide
Other illness
- Known history of HIV positivity
- Severe intercurrent bacterial, viral or fungal infection
- History of hypersensitivity to cornstarch or hydroxyethyl starch
Other
- Known primary immunodeficiency
- Patients with acute promyelocytic leukemia (APL)
- Known contraindication to protocol defined lymphodepleting
Who the study is looking for
- 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
Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.