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Alkylating agents

CAR-T Cell Therapy for Lymphoma

Phase 1
Recruiting
Led By Benjamin Tomlinson, MD
Research Sponsored by Benjamin Tomlinson
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2
The participant's malignancy is CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available or peripheral blood for circulating disease.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new immunotherapy to see if it can treat relapsed or difficult-to-treat lymphoid cancers.

Who is the study for?
This trial is for adults with certain blood cancers (like different types of leukemia and lymphoma) that have come back or didn't respond to treatment. They should be relatively healthy otherwise, not pregnant or breastfeeding, able to understand the study, and willing to use effective birth control.Check my eligibility
What is being tested?
Researchers are testing a new immunotherapy using T cells engineered to target CD19, a protein on cancer cells. Participants will also receive drugs Fludarabine and Cyclophosphamide to help these special T cells work better.See study design
What are the potential side effects?
Possible side effects include fever, fatigue, headache, muscle pain, low blood pressure and difficulty breathing. There's also a risk of more serious issues like neurological problems or an extreme immune response called cytokine release syndrome.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and am up and about more than half of my waking hours.
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My cancer is CD19 positive.
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I agree to use effective birth control or remain abstinent during and after treatment.
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I agree to use effective birth control or remain abstinent and not donate sperm during and for 6 months after treatment.
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I can understand and am willing to sign the consent form.
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My oxygen level is 92% or higher without extra oxygen.
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My lymphoma or leukemia has not improved after at least two treatments.
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My heart pumps well, with an ejection fraction of 40% or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Recommended phase II dose of human anti-CD19 CAR-T cells
Secondary outcome measures
Heart rate
Number of participants experiencing dose limiting toxicities
Number of participants experiencing grade 3 or more adverse events
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group B - ALLExperimental Treatment3 Interventions
Upon enrollment, peripheral blood mononuclear cells will be collected, and T-cell selection and manufacture of CAR-T cells will be done. Participants will receive 60 mg/Kg/IV Cyclophosphamide on day -6 and 25 mg/m^2 Fludarabine from day -5 to day -3. Participants with Acute Lymphoblastic Leukemia (and lymphoblastic lymphoma as a solid tumor equivalent) will be enrolled on this arm sequentially in a 3 + 3 design starting with infusion of CAR-T cells at DL1 on day 0 and 7. The maximum tolerated dose (MTD) will be determined and then 6 additional participants will be enrolled at the MTD.
Group II: Group A - NHL/CLLExperimental Treatment3 Interventions
Upon enrollment, peripheral blood mononuclear cells will be collected, and T-cell selection and manufacture of CAR-T cells will be done. Participants will receive 60 mg/Kg/IV Cyclophosphamide on day -6 and 25 mg/m^2 Fludarabine from day -5 to day -3. Participants with CD19+ lymphomas and chronic lymphocytic leukemia will be enrolled on this arm sequentially in a 3 + 3 design starting with infusion of CAR-T cells at dose level 1 (DL1) on day 0. The maximum tolerated dose (MTD) will be determined and then 6 additional participants will be enrolled at the MTD.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Benjamin TomlinsonLead Sponsor
3 Previous Clinical Trials
71 Total Patients Enrolled
Benjamin Tomlinson, MD1.01 ReviewsPrincipal Investigator - University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
2 Previous Clinical Trials
51 Total Patients Enrolled
1Patient Review
My sister was needlessly put through months of agony. She was constantly in the ER with the same symptoms she had before her eye was removed. The cancer had metastasized to her liver by the time they finally figured it out. They should have checked for cancer in the first place.

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04732845 — Phase 1
Non-Hodgkin's Lymphoma Research Study Groups: Group A - NHL/CLL, Group B - ALL
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT04732845 — Phase 1
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04732845 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Fully Human anti CD19 CAR-T Cell Dose obtained clearance from the relevant regulatory body?

"As this is a phase 1 trial, where safety and efficacy of the Fully human anti CD19 CAR-T Cell Dose are both unknown, we can only give it an estimated score of 1 on our rating scale."

Answered by AI

How many participants are sought for this experiment?

"Affirmative, according to the information on clinicaltrials.gov this investigation is actively seeking participants. It was initially advertised on April 26th 2021 and has since been updated October 4th 2022. The trial necessitates 36 volunteers from a single medical centre."

Answered by AI

Is there any published research detailing the effects of administering a Fully human anti CD19 CAR-T Cell Dose?

"At the present moment, there are 889 live trials studying Fully human anti CD19 CAR-T Cell Dose; of which 161 have reached Phase 3. Though most studies are located in Philadelphia, Pennsylvania, 28444 sites around the world offer this medication to participants."

Answered by AI

Are there still vacancies for participants in this research endeavor?

"Yes, the clinicaltrials.gov portal indicates that this research is still looking for participants. It was initially published on April 26th 2021 and most recently updated on October 4th 2022; 36 volunteers from one medical site are required to take part in this trial."

Answered by AI

What health conditions can be addressed by using a typical dosage of Fully human anti CD19 CAR-T Cells?

"Fully human anti CD19 CAR-T Cell Dose has been observed to have a positive impact on multiple sclerosis, various forms of leukemia, and mixed-cell type lymphoma."

Answered by AI
~2 spots leftby Jun 2024