Actively Recruiting
Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation
Led by National Cancer Institute (NCI) · Updated on 2026-04-28
155
Participants Needed
1
Research Sites
463 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: High-risk blood cancers (leukemias and lymphomas) often come back after treatment, and many cannot be cured with chemotherapy alone. These cancers may be treated and potentially cured in 2 ways: (1) Bone marrow transplant (allogeneic hematopoietic cell transplantation, or alloHCT) gives immune and blood stem cells from a donor. These new cells can attack the cancer and also grow into healthy blood. (2) Chimeric antigen receptor (CAR) T-cell therapy takes immune cells and changes them in a lab to better recognize and target certain cancers. But these 2 treatments are not usually given at the same time. Objective: To test alloHCT and CAR-T cell therapy, used together, in people with high-risk blood cancers. Eligibility: People aged 18 to 75 years with an aggressive blood cancer that has a protein on the surface called CD19. A healthy related donor aged 12 years or older is also needed; this donor may be a parent or child or may be some siblings or even extended family members, but has to be half-matched at something called the HLA (human leukocyte antigen). Design: Participants will be screened. They will have imaging scans, blood tests, and tests of their heart and lung function. They will have eye and dental exams. They may have fluid drawn from around their spinal cord (spinal tap) and tissue taken from inside a bone (bone marrow biopsy). Healthy donors will provide bone marrow, immune cells, and about 9 tablespoons of blood for both the recipient s treatment and for research. They will also provide stool, saliva, and oral swabs just for research. Recipient participants will stay in the hospital for 4 to 6 weeks. They will be given drugs over 6 days to prepare for the cell therapies. Both the donor bone marrow cells and CAR-T-cells will be given through a tube inserted into a vein. They will receive drugs to reduce complications after the treatments. Participants will remain within a 1-hour drive of the hospital for 2 to 3 months after they leave the hospital. They will have frequent visits during that time. They will continue to have periodic follow-up visits for 5 years. ...
CONDITIONS
Official Title
Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- Diagnosed with high or very high-risk CD19-expressing blood cancers
- Karnofsky performance score of 60% or higher
- Adequate heart function with ejection fraction of at least 45%
- Lung function with FEV-1 and DLCO at least 50% predicted
- Kidney function with creatinine clearance of 60 ml/min/1.73m2 or higher
- Liver function with total bilirubin no more than twice the upper limit of normal
- Liver enzymes (ALT and AST) no more than five times the upper limit of normal
- At least one available related donor aged 12 years or older who is HLA-haploidentical
- Women of childbearing potential agree to use highly effective contraception during the study and for 1 year after transplant
- Men agree to use effective contraception during the study and for 1 year after transplant and not donate sperm during this time
- Willingness to stop breastfeeding from start of study treatment through 1 year after transplant
- HIV positive participants must have undetectable viral load on effective therapy for at least 6 months
- Hepatitis B core antibody positive participants must have undetectable viral load
- Hepatitis C participants must be treated and cured or have undetectable viral load if currently treated
- Ability and willingness to provide informed consent
- Willingness to co-enroll on gene therapy follow-up study
- Commitment to remain near NIH hospital for at least 100 days post-transplant and have an adult caregiver during this period
You will not qualify if you...
- Receiving other investigational treatments within 3 weeks before conditioning
- Active central nervous system involvement of blood cancer
- Active non-blood cancers that are metastatic, relapsed, or not curable
- Use of checkpoint inhibitor therapy within 6 weeks before conditioning
- History of seizures
- Uncontrolled infections
- Allergic reactions to similar study drugs
- Positive pregnancy test in women of childbearing potential
- Uncontrolled serious illnesses making transplantation unsafe
- Donors who are pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
A
Amy H Chai
CONTACT
C
Christopher G Kanakry, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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