Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent … (NCT07572136) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells (TSLPR-CART) in Participants With Recurrent or Refractory CRLF2-R/TSLPR-Overexpressing B-Cell Acute Lymphoblastic Leukemia (B-ALL)
United States57 participantsStarted 2026-07-01
Plain-language summary
Background:
B-cell acute lymphoblastic leukemia (B-ALL) is a type of blood cancer. Some people with B-ALL have a gene mutation that makes the disease hard to treat. The mutation causes cancer cells to make too much of a protein called thymic stromal lymphopoietin receptor (TSLPR). Chimeric antigen receptor (CAR) T cell therapy is a treatment that takes immune cells (T cells) from a person s body and modifies them to attack specific proteins. Researchers want to test whether TSLPR-CART cells can be given safely to adults with forms of B-cell leukemia, and to learn whether the treatment may help fight these cancers.
Objective:
To test TSLPR-CART in people with B-ALL.
Eligibility:
People aged 18 years and older with B-ALL that did not respond or returned after treatment. They must have TSLPR on their B-ALL.
Design:
Participants will be screened. They will have imaging scans and tests of their heart function. Samples will be taken from their bone marrow. They will have a lumbar puncture: A needle will be inserted into their back to collect a sample of the fluid around the spinal cord.
Participants will undergo leukapheresis: Blood will be taken from their body through a tube. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different tube. The T cells will be used to create TSLPR-CART.
Participants will take chemotherapy over 5 days to prepare their body for the therapy; then they will receive the modified cells through a tube inserted into a vein. Staying in the hospital during part of the treatment is expected and participants will be monitored locally to evaluate for side effects. Approximately 1 month after receiving TSLPR-CART, participants will undergo evaluations to see how the TSLPR-CART impacted their leukemia. Participants will have follow-up visits for 2 years after TSLPR-CART either at NIH or at home....
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Documentation of pathologic confirmation of a diagnosis of B-Cell acute lymphoblastic leukemia (ALL).
. TSLPR+ expression must be detected on \>=80% of the malignant cells by NSR device. Note: TSLPR+ expression does not need to be repeated by NSR device if there is a documentation of TSLPR surface expression by flow cytometry from a Clinical Laboratory Improvement Amendments (CLIA) approved laboratory.
. Participants must have a disease that is relapsed or refractory after initial systemic therapy and at least one salvage treatment, and must either be ineligible for, cannot access in a timely manner, or declined alternative curative options (including commercial CAR Tcell constructs\*, and/or have relapsed after allogeneic HSCT).
. Participants must have measurable or evaluable disease at the screening, defined by any evidence of MRD or positron emission tomography (PET)-avid extramedullary disease
. Age \>= 18 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on finding a safe dose range rather than proving the treatment works — given that, does my current situation make it reasonable to consider a trial at this early stage, or should we try other established options first?
2The trial uses something called a 'tEGFR suicide switch' that can be used to turn off the CAR T cells if there are serious side effects — can you explain how that safety mechanism works and what kinds of side effects it's designed to protect against?
3Since this trial is listed as 'not yet recruiting,' do you have any sense of when it might open, and is it worth waiting for, or should we be pursuing other treatments in the meantime?
4My cancer needs to overexpress CRLF2-R or TSLPR to be eligible for this trial — has my tumor been tested for these markers, and if not, is that something we should do now to keep this option open?
5Because this is a first-in-human type dose-escalation study, what is actually known so far about how TSLPR-targeted CAR T cells behave in people, and how does that compare to the risks of my other treatment options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess the safety of administering escalating doses of TSLPR-CART containing a tEGFR suicide switch to determine an MTD
. Clinical performance status: Karnofsky \>= 50%. Participants who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
. Participants must have adequate organ and marrow function as defined below:
. Cardiac function: left ventricular ejection fraction (LVEF) \>=45% or fractional shortening \>= 28%, and no clinically significant electrocardiogram (EKG) findings
Exclusion criteria
. Recurrent or refractory leukemia limited to isolated testicular or isolated CNS disease
. CNS 3 disease including participants with radiologically detected active CNS lymphoma, or participants who have cranial nerve palsy from active CNS leukemia. Note: Chronic complications of prior CNS disease are not exclusionary in the absence of active disease (e.g., blindness from prior ocular CNS disease or persistent cranial nerve palsy)
. Hyperleukocytosis (\>=50,000 blasts/mcL)
. Positive serum or urine beta-human chorionic gonadotropin (beta-HCG) pregnancy test performed in WOCBP at screening.
. Washout criteria (time prior to apheresis or prior to start of LD if apheresis is not done on this protocol):
. Human immunodeficiency virus (HIV) infection, as measured by seropositivity for HIV antibody.
. Hepatitis B virus (HBV) infection, as measured by positivity for hepatitis B surface antigen (HbsAg).
. Hepatitis C virus (HCV) infection, as measured by seropositivity for hepatitis C.