TSLPR-CART for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called TSLPR-CART for individuals with B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. TSLPR-CART uses a person's own immune cells, modified to specifically target and kill cancer cells that overproduce a protein called TSLPR. The trial aims to determine if this treatment can benefit those whose cancer did not respond to previous treatments or recurred. It suits adults with B-ALL who have a specific gene mutation and have not succeeded with other treatments. Participants will receive their modified immune cells back after a preparation period and will be monitored to assess the treatment's effects. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative therapy.
Do I need to stop my current medications for the trial?
The trial requires a washout period (time without taking certain medications) of at least 2 weeks for most systemic chemotherapy and investigational agents, and 3 weeks for radiation therapy. However, there are exceptions for certain medications like intrathecal chemotherapy and some maintenance therapies, which do not require a washout period.
Is there any evidence suggesting that TSLPR-CART is likely to be safe for humans?
Research shows that TSLPR-CART, a type of CAR T-cell therapy, is undergoing safety testing in people with B-cell acute lymphoblastic leukemia (B-ALL). This marks the first human trial of this treatment. The goal is to assess the safety of TSLPR-CART for patients whose leukemia did not respond to treatment or recurred.
Previous studies on other CAR T-cell therapies have shown promising results. For instance, one study found that a similar CAR T-cell treatment improved leukemia in 83% of patients, either partially or completely, after just one treatment.
When testing new treatments like TSLPR-CART, safety remains the primary focus. Although this study is in its early stages, it aims to closely monitor how patients respond to the treatment and identify any side effects. While specific side effect data for TSLPR-CART is not yet available, similar treatments have shown good responses in other studies.12345Why do researchers think this study treatment might be promising?
Unlike the standard chemotherapy and targeted therapies for acute lymphoblastic leukemia (ALL), TSLPR-CART is a cutting-edge treatment that involves genetically modifying a patient's own immune cells to better recognize and attack cancer cells. This therapy specifically targets the TSLPR protein on leukemia cells, which is not the focus of current treatments. Researchers are excited because TSLPR-CART has the potential to provide a more precise attack on cancer cells, potentially leading to fewer side effects and improved outcomes for patients.
What evidence suggests that TSLPR-CART might be an effective treatment for B-ALL?
Research has shown that CAR T-cell therapy effectively treats acute lymphoblastic leukemia (ALL), with over 70% of patients experiencing significant improvements. This treatment modifies a patient's immune cells to identify and destroy cancer cells. In this trial, participants will receive TSLPR-CART, which specifically targets a protein called TSLPR, often found in large amounts on some cancer cells. Studies have demonstrated that CAR T-cell therapy can greatly benefit people with B-cell acute lymphoblastic leukemia (B-ALL) that has returned or is difficult to treat by reducing the number of cancer cells. This new approach has successfully improved outcomes for patients with blood cancers.35678
Who Is on the Research Team?
John W Glod, M.D.
Principal Investigator
National Cancer Institute (NCI)
Are You a Good Fit for This Trial?
This trial is for adults (18+) with B-cell acute lymphoblastic leukemia that has come back or not responded to treatment, and whose cancer cells have high levels of TSLPR. Participants must be in fair health, have enough platelets and white blood cells, and no other curative options available.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Apheresis and Manufacturing
Participants undergo apheresis and TSLPR-CART is manufactured from the enriched T-cell product
Lymphodepletion and Treatment
Participants receive a lymphodepletion regimen of fludarabine and cyclophosphamide followed by an infusion of TSLPR-CART
Dose Escalation and Expansion
Participants receive escalating doses of TSLPR-CART to determine the maximum tolerated dose, followed by treatment at MTD in an expansion cohort
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants are evaluated for overall survival and response durability
What Are the Treatments Tested in This Trial?
Interventions
- TSLPR-CART
Trial Overview
The study tests a new CAR T cell therapy called TSLPR-CART made from the patient's own immune cells to target their leukemia. Before receiving these modified cells by IV, participants get chemotherapy drugs cyclophosphamide and fludarabine to prepare their body.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
TSLPR-CART at MTD or highest dose administered
TSLPR-CART at escalating doses
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor
Citations
CAR T-Cells in Acute Lymphoblastic Leukemia - PMC - NIH
The present article overviews the use of CAR T-cell in the treatment of ALL, summarizing the results of relevant clinical trials and discussing future ...
Anti-CRLF2-R/TSLPR Chimeric Antigen Receptor T Cells ...
Chimeric antigen receptor-expressing T cells (CAR) have proven highly successful in patients with cancer with dramatic responses in >70% of patients with ...
Use of CAR T-cell for acute lymphoblastic leukemia (ALL) ...
In this review different generations, challenges, and clinical studies related to chimeric antigen receptor (CAR) T-cells for ALL treatment are discussed.
Chimeric antigen receptor T-cell therapy for T-cell acute ...
In this article, we discuss potential targets for CAR T-cell therapy of T-ALL with an emphasis on CD7, and review CAR configurations as well as early clinical ...
Chimeric antigen receptor T-cell therapy for T-cell acute ...
Chimeric antigen receptor (CAR) T-cell therapy is a new and effective treatment for patients with hematologic malignancies.
Chimeric Antigen Receptor T-cell Therapy in the Treatment of ...
One-year overall survival rate of 60%, event-free survival rate of 32%. Relapses likely due to limited long-term persistence of AUTO3. Favorable ...
7.
ashpublications.org
ashpublications.org/blood/article/146/Supplement%201/4101/555201/From-bench-to-IND-Validation-of-TSLPR-CAR-T-cellsFrom bench to IND: Validation of TSLPR CAR T-cells reveal ...
A clinical-grade TSLPR CAR vector incorporating a truncated EGFR (tEGFR) safety tag was validated using a Prodigy-based closed-system ...
8.
ctv.veeva.com
ctv.veeva.com/study/phase-i-dose-escalation-study-of-anti-crlf2-r-tslpr-chimeric-antigen-receptor-t-cells-tslpr-cart-iPhase I Dose Escalation Study of Anti-CRLF2-R/TSLPR ...
This is a first-in-human Phase I trial aimed to determine the safety of TSLPR-CART in participants with recurrent or refractory B-cell ALL.
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