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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and optimal dose of CD70-CAR T cell therapy in children and young adults aged 21 years or younger who have certain difficult-to-treat or returning blood cancers. These include acute myelogenous leukemia, myelodysplastic syndrome, acute lymphoblastic leukemia, lymphoma, and mixed phenotype acute leukemia that test positive for CD70. This phase 1 study aims to find the highest dose patients can tolerate and to observe the treatment's activity against cancer cells in bone marrow and other sites. Participants receive a lymphodepleting chemotherapy regimen consisting of fludarabine and cyclophosphamide over several days to prepare the body, followed by a single infusion of their own genetically modified CD70-CAR T cells. The study tests three different dose levels of the CAR T cells to assess safety and tolerability. Mesna is also given to reduce chemotherapy side effects. Treatment is carefully timed, with chemotherapy given on days -4 to -2 and a rest day on day -1, followed by the CAR T cell infusion on day 0 or day +1. During the study, participants are monitored closely for safety and treatment effects, with the primary focus on the maximum tolerated dose assessed within 28 days after the CAR T cell infusion. Researchers will collect data on the therapy's impact on leukemia in bone marrow and other disease sites. The study measures participants' health status, life expectancy, and performance scores, ensuring they are clinically stable and recovered from any prior treatments such as stem cell transplants. The total monitoring period and follow-up extend over several weeks post-infusion to evaluate outcomes and side effects.
CONDITIONS
Brief Title
CAR T-cell Therapy Directed to CD70 for Pediatric Patients With Hematological Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years old or younger
- Diagnosis of relapsed or refractory CD70-positive hematological malignancy
- Relapsed disease defined as recurrence after a prior complete remission
- Refractory disease defined as persistent disease despite 3 cycles of induction chemotherapy
- Relapsed/refractory CD70+ AML or MDS with CD70 positivity
- Relapsed/refractory CD70+ B-cell ALL with CD19 negative/dim or ineligible for CD19 therapies
- Relapsed/refractory CD70+ T-cell ALL with CD70 positivity
- Relapsed/refractory Mixed Phenotype Acute Leukemia (MPAL) with CD70 positivity
- Relapsed/refractory CD70+ lymphoma with CD19 negative/dim or ineligible for CD19 therapies
- Estimated life expectancy greater than 12 weeks
- Karnofsky or Lansky performance score 50 or higher
- Clinically recovered from prior allogeneic hematopoietic cell transplantation with no active graft-versus-host disease
- No donor lymphocyte infusion within 28 days prior to apheresis
- Identified hematopoietic cell transplantation donor
- For females of childbearing age: not pregnant, negative pregnancy test within 7 days prior to enrollment, and not breastfeeding with intent to breastfeed
You will not qualify if you...
- Known primary immunodeficiency
- Known history of HIV positivity
- Severe ongoing bacterial, viral, or fungal infection
- History of hypersensitivity to cornstarch or hydroxyethyl starch
- Diagnosis of acute promyelocytic leukemia (APL)
- Contraindication to lymphodepleting chemotherapy regimen of fludarabine and cyclophosphamide
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 days
Participants receive a chemotherapy regimen with fludarabine and cyclophosphamide to prepare the body for CAR T-cell infusion.
3 visits for chemotherapy administration
Duration - 1 day
Participants receive a single autologous infusion of CD70-CAR T cells to treat their hematological malignancy.
1 infusion visit
Duration - 28 days
Participants are monitored for safety and to assess the maximum tolerated dose of the CAR T cells over 28 days after infusion.
Multiple follow-up visits during 28 days post-infusion
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
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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