Autologous TriCAR T-cells and lymphodepletion chemotherapy for Leukemia, B-Cell

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Texas Children's Hospital, Houston, TX
Leukemia, B-Cell+1 More
Autologous TriCAR T-cells and lymphodepletion chemotherapy - Genetic
Eligibility
Any Age
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a new type of T cell that has been genetically modified to target ALL cells can be used to treat ALL.

See full description

Eligible Conditions

  • Leukemia, B-Cell

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Autologous TriCAR T-cells and lymphodepletion chemotherapy will improve 1 primary outcome in patients with Leukemia, B-Cell. Measurement will happen over the course of within 28 days of the TriCAR T cell infusion..

Day 28
Dose-limiting toxicity (DLT) rate by CTCAE v5.0

Trial Safety

Trial Design

1 Treatment Group

Autologous TriCAR T-Cells and lymphodepletion chemotherapy
1 of 1
Experimental Treatment

This trial requires 38 total participants across 1 different treatment group

This trial involves a single treatment. Autologous TriCAR T-cells And Lymphodepletion Chemotherapy is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Autologous TriCAR T-Cells and lymphodepletion chemotherapy
Genetic
Three dose levels will be evaluated. The TriCAR T-cells will be administered after lymphodepletion chemotherapy with Cyclophosphamide and fludarabine.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 28 days of the tricar t cell infusion.
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly within 28 days of the tricar t cell infusion. for reporting.

Who is running the study

Principal Investigator
B. S.
Prof. Bahey Salem, MD
Baylor College of Medicine

Closest Location

Texas Children's Hospital - Houston, TX

Eligibility Criteria

This trial is for patients born any sex of any age. You must have received 1 prior treatment for Leukemia, B-Cell or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Diagnosis of refractory or recurrent B cell Acute Lymphoblastic Leukemia (B-ALL) with expression of CD19, CD20 and/or CD22
Projected age greater than or equal to 12 months at the time of TriCAR T cell infusion
Life expectancy of greater than or equal to 8 weeks
Weight greater than or equal to 10 kg
Subjects greater than or equal to 18 years of age must have the ability to give informed consent according to applicable regulatory and local institutional requirements. Legal guardian's consent must be obtained for subjects < 18 years of age. Assent will be obtained from pediatric subjects and according to applicable regulatory and local institutional requirements. Adults with cognitive impairment who are unable to consent and those with Down's syndrome are also eligible for this protocol with consent/assent according to applicable regulatory and local institutional requirements.
Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued greater than or equal to 7 days prior to collection, with the exception of intrathecal chemotherapy and maintenance chemotherapy but greater than or equal to 72 hours prior to collection (for the subset of subjects who relapse during maintenance); both of which may be administered at any point pre-study or upon enrollment
Steroid use: All systemic corticosteroid therapy (unless physiologic replacement dosing of less than or equal to 12mg/m2/day hydrocortisone or equivalent) must be discontinued greater than or equal to 7 days prior to collection
Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued greater than or equal to 3 days prior to collection
Hydroxyurea: must be discontinued greater than or equal to 1 day prior to collection
Prior CAR-T cell therapy: must be at least 30 days from most recent CAR-T cell infusion prior to collection

Patient Q&A Section

Who should consider clinical trials for leukemia?

"In patients with life-threatening symptomatic disease, it is important that patients and physicians discuss potential benefits and risks of clinical trial participation before deciding to enroll in a clinical trial. Patients who are considering clinical trial participation should carefully evaluate whether the proposed treatment appears to provide meaningful survival benefit in their own situation." - Anonymous Online Contributor

Unverified Answer

Can leukemia be cured?

"No definitive evidence exists to suggest that any cancer can be cured. However, recent advances in chemotherapy and immunotherapy offer hope for long-term survival in patients with ALL treated according to current clinical protocols. Patients with newly diagnosed ALL should receive a full evaluation to determine prognosis and direct therapy accordingly. A patient's age at diagnosis and response to initial chemotherapy predicts eventual outcome." - Anonymous Online Contributor

Unverified Answer

What is autologous tricar t-cells and lymphodepletion chemotherapy?

"Autologous T-cell depletion with CD34+ selection before allogeneic T-cell infusion was associated with improved clinical outcomes in patients with relapsed/refractory B-cell chronic lymphocytic leukemia. ClinicalTrials.gov Identifier: NCT00536682." - Anonymous Online Contributor

Unverified Answer

What are common treatments for leukemia?

"The most commonly used treatments for leukemia include chemotherapy and radiation therapy. However, many patients respond well to combinations of drugs, including anthracyclines, taxanes, proteasome inhibitors, immunomodulators, alkylating agents, cyclo-oxygenase inhibitors, and antimetabolites. This article focuses on four chemotherapy regimens used to treat acute myeloid leukemia.\n\nIn 1955, César Milstein, Edward B. Schramm, and Paul Gerson developed a method for isolating antibodies against foreign proteins called hybridomas." - Anonymous Online Contributor

Unverified Answer

How serious can leukemia be?

"Leukemia is a life threatening disease where timely diagnosis and optimal treatment are critical. Most patients with AML will relapse despite intensive therapy. People who have had leukemia should be advised to maintain a low-fat diet to reduce their risk of developing secondary cancers. Some people with AML will die within a year of diagnosis. The average survival time after diagnosis is only 10 months. Patients with ALL have improved outcomes today because they receive aggressive therapy for longer periods of time than before and because new treatments that target ALL have been developed. However, most children with ALL must undergo painful and risky procedures such as bone marrow transplantation. They also face a high rate of relapse and death within 5 years of diagnosis." - Anonymous Online Contributor

Unverified Answer

How many people get leukemia a year in the United States?

"Findings from a recent study demonstrates the need for improved data collection and dissemination of information regarding the incidence and mortality rates of leukemia. If the incidence and mortality rate are higher than what has been reported by Medicare and state-based Medicaid programs, this may indicate that these programs do not adequately cover patients with leukemia." - Anonymous Online Contributor

Unverified Answer

Is autologous tricar t-cells and lymphodepletion chemotherapy safe for people?

"Autologous T-cell transplantation followed by lymphodepletion therapy was well tolerated and highly effective in patients with relapsed/refractory AL/AML. Longer follow up is needed to assess whether these results translate into improved outcome." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets leukemia?

"This disease occurs mostly in middle-aged adults; however, it also affects children and the elderly. The overall median age of diagnosis was 57 years old with a male-to-female ratio of 1.1:1." - Anonymous Online Contributor

Unverified Answer

Does autologous tricar t-cells and lymphodepletion chemotherapy improve quality of life for those with leukemia?

"Autologous T-cell transplantation appears to improve QOL in patients with chronic myelogenous leukemia and acute lymphocytic leukemia. Findings from a recent study supports the use of autologous T-cell transplantation as an alternative treatment strategy in leukemia." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving autologous tricar t-cells and lymphodepletion chemotherapy?

"This is the first clinical trial evaluating the use of autologous T cells in patients with relapsed/refractory non-Hodgkin Lymphoma. Results from a recent clinical trial suggest that this approach may provide an additional therapeutic role in certain groups of patients with refractory NHL." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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