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CAR T-cell Therapy
CAR T-Cell Therapy for Leukemia
Phase 1
Recruiting
Research Sponsored by Dr. Melody Smith, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Summary
This trial is testing a treatment that uses special immune cells from a donor, modified to target and kill cancer cells, in adults with a specific type of blood cancer. These cells act like guided missiles, finding and destroying cancer cells by recognizing specific markers.
Who is the study for?
Adults aged 18-65 with B-cell Acute Lymphoblastic Leukemia who have a matched related donor for T cell and stem cell grafts. Participants should have high-risk ALL features or persistent disease after treatment, adequate organ function, and no history of certain infections or autoimmune CNS involvement. They must not be pregnant, breastfeeding, or unwilling to use birth control post-treatment.
What is being tested?
The trial tests the safety of CD19/CD22-CAR T cells from donors following myeloablative conditioning and Orca-T in adults with B-cell ALL. It aims to enhance leukemia defense without increasing acute GVHD (graft versus host disease) or graft failure.
What are the potential side effects?
Potential side effects may include immune reactions like acute GVHD where the body attacks the new cells, infection risks due to weakened immunity, organ inflammation from CAR T-cells, infusion-related reactions, and general discomfort.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Bone Transplantation
Number of patients who received donor CD19/CD22-CAR T cells
Secondary study objectives
Cumulative incidence of disease progression
Frequency of secondary graft failure
Infectious disease complication
+2 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment2 Interventions
Bayesian dose escalation design for the dosing of the donor CD19/CD22-CAR T cells
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Lymphocytic Leukemia include CAR T-cell therapies, BTK inhibitors, BCL2 inhibitors, and monoclonal antibodies. CAR T-cell therapies, such as CD19/CD22-CAR T cells, involve modifying a patient's T cells to target and eliminate malignant B-cells by recognizing specific antigens like CD19 and CD22.
BTK inhibitors (e.g., ibrutinib) block Bruton's tyrosine kinase, disrupting B-cell receptor signaling and leading to cancer cell death. BCL2 inhibitors (e.g., venetoclax) promote apoptosis in cancer cells by inhibiting the BCL2 protein, which normally helps cells survive.
Monoclonal antibodies (e.g., rituximab) target specific proteins on the surface of cancer cells, marking them for destruction by the immune system. These treatments are crucial as they offer targeted approaches to eliminate malignant cells, improve patient outcomes, and manage disease progression.
Cellular Therapy Advances in Chronic Lymphocytic Leukemia and Richter's Syndrome.
Cellular Therapy Advances in Chronic Lymphocytic Leukemia and Richter's Syndrome.
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Who is running the clinical trial?
Dr. Melody Smith, MD, MSLead Sponsor
Crystal Mackall, MDLead Sponsor
4 Previous Clinical Trials
199 Total Patients Enrolled
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,376 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of HIV, Hepatitis B, or Hepatitis C.I can take care of myself but may not be able to do heavy physical work.I haven't had a heart attack or other major heart issues in the last year.I have antibodies against my donor's tissue.I do not have any serious infections, or if I do, they are under control.I am on low-dose corticosteroids or other drugs that suppress my immune system.I have active acute lymphoblastic leukemia.I have an autoimmune disease and have used immunosuppressive drugs in the past year.I do not have any brain-related health conditions that could affect my participation.My heart, liver, kidneys, lungs, and brain are functioning well.I have been cancer-free for at least 3 years, except for non-severe types like nonmelanoma skin cancer.I am between 18 and 65 years old.My cancer has come back or didn't fully go away, confirmed twice.I am scheduled for a treatment that reduces T cells, with a washout period if previously treated.My cancer cells have shown CD19 at some point since diagnosis.I can understand and agree to the study's procedures, or I have someone who can consent for me if needed.My donor is a perfect match for me based on specific genetic markers.I have a family member willing to donate cells for my CAR T cell therapy.My leukemia didn't respond to my first chemotherapy or came back, or I have high-risk features.
Research Study Groups:
This trial has the following groups:- Group 1: Dose escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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