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CAR T-cell Therapy

CAR T-cell Therapy for Lymphoma and Leukemia

Phase 1
Recruiting
Led By Sumithira Vasu, MD
Research Sponsored by Sumithira Vasu
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with refractory high-grade B-cell lymphoma relapsing within 12 months of autologous stem cell transplant
Patients with CD19 and/or CD20 and/or CD22 positive lymphoid malignancy, who received blinatumomab or inotuzumab, aged >= 18 years, with ECOG performance status =< 2, adequate organ function, and ability to understand and sign informed consent
Must not have
Evidence of myelodysplasia, positive hepatitis B core antibody or surface antigen, clinically relevant CNS pathology, autoimmune disease with recent immunosuppressive medication requirement, or live vaccines given within 28 days prior to lymphodepleting chemotherapy
Active central nervous system or meningeal involvement by lymphoma or leukemia, active malignancy other than specified exceptions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights
No Placebo-Only Group

Summary

This trial tests the safety and best dose of a new treatment using modified immune cells (CAR T-cells) for patients with certain recurring or hard-to-treat lymphoid cancers. The treatment involves giving patients a brief period of chemotherapy followed by an infusion of these specially designed cells to target and kill cancer cells. Anti-CD19 CAR T-cells currently represent transformational therapy for relapsed/refractory aggressive B-cell lymphomas where durable remissions can be induced in patients with previously incurable chemotherapy-refractory disease.

Who is the study for?
Adults with certain relapsed or refractory lymphoid cancers, including non-Hodgkin lymphoma and various types of leukemia. Participants must have tried at least two prior therapies, have a minimum level of white blood cells, good heart and lung function, and agree to use highly effective contraception. Excluded are those with recent transplants, active infections or other malignancies that could affect the trial's safety.
What is being tested?
The trial is testing genetically engineered CAR T-cells targeting CD19/CD20/CD22 on cancer cells following chemotherapy (cyclophosphamide and fludarabine). It aims to determine the safest dose for infusion of these modified T-cells in patients whose cancers haven't responded well to previous treatments.
What are the potential side effects?
Potential side effects include immune system reactions leading to inflammation in different body parts, symptoms related to infusion such as fever or chills, fatigue, possible organ dysfunction due to targeted cell destruction by CAR T-cells, and increased risk of infection from pre-infusion chemotherapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My high-grade B-cell lymphoma came back within a year after my stem cell transplant.
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I am 18 or older with a specific type of blood cancer, have received certain treatments, can move around, and understand the consent form.
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I have CLL and have been treated with at least 2 therapies including a BTK inhibitor and venetoclax.
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I have acute B-lymphoblastic leukemia that has not responded to at least 2 treatments or I cannot undergo a stem cell transplant.
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I have lymphoma or leukemia that has not improved after at least two treatments.
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I agree to not have unprotected sex or donate sperm.
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I have B-prolymphocytic leukemia that didn't respond to 1-2 treatments and can't have a stem cell transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I don't have myelodysplasia, hepatitis B, significant brain issues, recent autoimmune treatment, or recent live vaccines.
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I do not have active brain or spinal cord cancer.
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I had a stem cell transplant using my own cells less than 6 weeks ago.
Select...
I haven't had a stem cell transplant or live vaccines recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Complete response rate
Incidence of adverse events
Overall response rate
+2 more
Other study objectives
Correlation between CD19/20/22 expression on disease response
Correlation between cytokine serum concentrations and disease response
Presence of measurable CAR-T cells

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)Experimental Treatment3 Interventions
LYMPHODEPLETIVE REGIMEN: Patients receive cyclophosphamide IV over 60 minutes on day -6 and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive anti-CD19/CD20/CD22 CAR-T cells IV over 5-30 minutes on day 0 and 7.
Group II: Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells)Experimental Treatment3 Interventions
LYMPHODEPLETIVE REGIMEN: Patients receive cyclophosphamide IV over 60 minutes on day -6 and fludarabine IV over 30 minutes on days -5 to -3 in the absence of disease progression or unacceptable toxicity. CAR T-CELL THERAPY: Patients receive anti-CD19/CD20/CD22 CAR-T cells IV over 5-30 minutes on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine Phosphate
1997
Completed Phase 3
~2390

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 Acute Lymphoblastic Leukemia (ALL) include chemotherapy, targeted therapy, and immunotherapy. Among these, CAR T-cell therapy, such as anti-CD19/CD20/CD22 CAR T-cells, is particularly noteworthy. This treatment involves genetically engineering a patient's own T-cells to express chimeric antigen receptors (CARs) that specifically target CD19, CD20, and CD22 proteins on the surface of leukemia cells. Once infused back into the patient, these CAR T-cells can recognize, bind to, and kill the cancer cells. This targeted approach is significant for ALL patients as it offers a personalized treatment option that can lead to remission, especially in cases where the disease is refractory or has relapsed after conventional therapies.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,917 Previous Clinical Trials
41,014,431 Total Patients Enrolled
Sumithira VasuLead Sponsor
5 Previous Clinical Trials
86 Total Patients Enrolled
Sumithira Vasu, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
2 Previous Clinical Trials
33 Total Patients Enrolled

Media Library

Anti-CD19/CD20/CD22 CAR T-Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05418088 — Phase 1
Chronic Lymphocytic Leukemia Research Study Groups: Cohort A (lymphodepletion; anti-CD19/CD20/CD22 CAR-T cells), Cohort B (lymphodepletion, anti-CD19/CD20/CD22 CAR-T cells)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Anti-CD19/CD20/CD22 CAR T-Cells Highlights & Side Effects. Trial Name: NCT05418088 — Phase 1
Anti-CD19/CD20/CD22 CAR T-Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05418088 — Phase 1
~5 spots leftby Apr 2025