Actively Recruiting
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Led by St. Jude Children's Research Hospital · Updated on 2026-01-23
18
Participants Needed
1
Research Sites
349 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 21 years old or younger
- Diagnosed with relapsed or refractory CD70-positive hematological malignancy
- Relapsed disease means cancer returned after a prior complete remission
- Refractory disease means persistent disease despite 3 cycles of induction chemotherapy
- For AML or MDS: relapsed or refractory CD70-positive disease
- For B-cell ALL: relapsed CD70-positive and CD19 negative/dim or ineligible for CD19 therapies, including 2nd or greater relapse or relapse after allogeneic hematopoietic stem cell transplant (HSCT)
- For T-cell ALL: relapsed/refractory CD70-positive disease
- For mixed phenotype acute leukemia (MPAL): relapsed/refractory CD70-positive disease
- For lymphoma: relapsed CD70-positive and CD19 negative/dim or ineligible for CD19 therapies, including 2nd or greater relapse or relapse after allogeneic HSCT
- Estimated life expectancy greater than 12 weeks
- Karnofsky or Lansky performance score of 50 or higher
- Patients with prior allogeneic HSCT must be recovered, have no active graft-versus-host disease (GVHD), and no donor lymphocyte infusion within 28 days before apheresis
- Have an identified hematopoietic cell transplantation donor
- For females of childbearing potential: not breastfeeding and negative pregnancy test within 7 days prior to enrollment
You will not qualify if you...
- Known primary immunodeficiency
- Known history of HIV positivity
- Severe active bacterial, viral, or fungal infection
- History of allergy to cornstarch or hydroxyethyl starch
- Diagnosis of acute promyelocytic leukemia (APL)
- Contraindication to lymphodepleting chemotherapy with fludarabine and cyclophosphamide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Swati Naik, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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