Actively Recruiting
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
Led by St. Jude Children's Research Hospital · Updated on 2026-05-19
70
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying newer ways to transplant blood cells from partially matched family donors to children with high-risk CD19 positive acute lymphoblastic leukemia (ALL) and other B-cell malignancies. This Phase I trial focuses on evaluating the safety and feasibility of adding CD19-CAR memory T cells after a special type of donor transplantation that removes certain T cells and CD19 B cells. The goal is to improve outcomes for pediatric patients with relapsed or refractory CD19 positive B-cell cancers. The treatment involves a conditioning chemotherapy regimen including drugs like anti-thymocyte globulin, fludarabine, cyclophosphamide, melphalan, and thiotepa to prepare the patient. On day 0, patients receive an infusion of progenitor cells from a family donor that has been depleted of specific T cells and CD19 B cells using the CliniMACS system. Starting as early as day 14, patients receive the previously created CD19-CAR memory T cell product. Donors undergo two collections: one for stem cell infusion and another for creating the CAR T-cell product. During the study, participants are closely monitored for safety and effectiveness of the infused CAR T cells. Researchers will collect samples to study immune responses and adverse events. Key outcomes include assessing safety within 100 days after transplant, feasibility in the first 60 days, and longer-term measures like overall survival, relapse-free survival, graft-versus-host disease incidence, and immune-related side effects up to three years post-transplant. The study will last several years with ongoing follow-up.
CONDITIONS
Brief Title
CD45RA-depleted CD19-CAR T Cell Consolidation After TCRαβ+/CD19 B Cell-depleted Haploidentical Hematopoietic Cell Transplantation for Relapsed/Refractory CD19+ ALL and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 years or younger
- Diagnosed with high-risk CD19+ B cell acute lymphoblastic leukemia (ALL) in first or second complete remission or any CD19+ B-cell ALL in third or later remission
- If prior central nervous system (CNS) leukemia, must be treated and in CNS complete remission
- Left ventricular ejection fraction greater than 40% or shortening fraction at least 25%
- Creatinine clearance or glomerular filtration rate at least 50 ml/min/1.73m2
- Forced vital capacity at least 50% of predicted or pulse oximetry at least 92% on room air
- Karnofsky or Lansky performance score at least 50
- Bilirubin less than or equal to 3 times the upper limit of normal for age
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than or equal to 5 times the upper limit of normal for age
- Have a family donor who is at least a single haplotype match (4 of 8) and at least 18 years old
- Donor is HIV negative and agrees to use birth control if sexually active until 2 weeks after mobilization and apheresis
You will not qualify if you...
- Has a suitable HLA-identical sibling or fully matched unrelated donor (12/12) available in appropriate time frame
- Has any other active malignancy besides the one being treated with transplant
- Has received a prior allogeneic hematopoietic cell transplant
- Pregnant or breastfeeding
- If sexually active, does not agree to use birth control until 6 months after T cell infusion
- Has any severe uncontrolled bacterial, fungal, or viral infection
- Donor who is pregnant or breastfeeding
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.
1 visit (in-person)
Duration - Approximately 12 days
Participants receive a conditioning chemotherapy regimen including Anti-Thymocyte Globulin, Fludarabine, Cyclophosphamide, Melphalan, and Thiotepa before transplantation.
Daily visits during conditioning days
Duration - 1 day
Participants receive an infusion of TCRαβ+/CD19 B cell depleted progenitor cells on Day 0.
1 visit (in-person) on day of infusion
Duration - From day +14 onward as scheduled
Starting as early as day +14, participants receive infusion of the previously manufactured CD19-CAR(Mem) T cell product.
1 visit for CAR T cell infusion plus follow-up visits for monitoring
Duration - Up to 100 days post-transplant and beyond for long-term outcomes
Participants are monitored for safety, efficacy, and collection of correlative samples after CAR T cell infusion.
Multiple visits for safety and efficacy monitoring during first 100 days and periodic follow-up visits thereafter
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here