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CAR T-cell Therapy

CAR-T Cell Therapy for Lymphoma and Leukemia

Phase 1
Recruiting
Led By Anusha Kalbasi, MD
Research Sponsored by Jonsson Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MCL, FL, CLL, and SLL: primary refractory; relapsed after three or more prior rounds of therapy
DLBCL and PMBCL: primary refractory; relapsed after two prior lines of therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing the effects of CAR-T cells on patients with B-cell lymphoma or chronic lymphocytic leukemia that has come back or stopped responding to treatment.

Who is the study for?
This trial is for adults with certain types of B-cell lymphoma or chronic lymphocytic leukemia that haven't improved after standard treatments. Participants need to have a specific level of organ function, blood cell counts within set ranges, and at least 30% of their cancer cells must express CD19 or CD20 proteins.Check my eligibility
What is being tested?
The trial tests modified immune cells (CD19/CD20 CAR-T Cells) combined with chemotherapy drugs cyclophosphamide and fludarabine phosphate. It aims to find the safest dose and see how effective this treatment is against recurrent or refractory non-Hodgkin's B-cell lymphoma or chronic lymphocytic leukemia.See study design
What are the potential side effects?
Possible side effects include flu-like symptoms, fatigue, fever, chills, breathing difficulties, low blood pressure, nausea, headache; there may also be risks related to the infusion process itself and potential serious complications like neurologic events or severe immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer did not respond to initial treatment or has come back after 3+ treatments.
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My lymphoma did not respond to initial treatment or has returned after two treatments.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My lymphoma or leukemia does not respond to standard treatments.
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My lymphoma tumor is at least 1.5 cm^3 in size.
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My cancer cells are mostly positive for CD19 or CD20.
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I am willing to undergo a procedure to collect white blood cells.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities
Incidence of adverse events
Secondary outcome measures
Chimeric antigen receptor (CAR) T-cell (T) 19/20 bispecific transgenic T-cell persistence
Clinical response
Duration of B-cell aplasia following CART19/20 infusion.
+5 more
Other outcome measures
Analysis of proteins/cytokines (c-reactive protein (CRP), interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α), and interferon-gamma (IFN-γ)) concentration in peripheral blood following CART19/20 infusion.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (fludarabine, cyclophosphamide, CD19/CD20 T-cells)Experimental Treatment4 Interventions
CONDITIONING CHEMOTHERAPY: Patients receive fludarabine phosphate IV over 30 minutes and cyclophosphamide IV over 60 minutes 5, 4, and 3 days before cell infusion. T-CELL INFUSION: Patients receive CD19/CD20 CAR-T cells IV on day 0. Patients with cytokine release syndrome may also receive tocilizumab IV on day 2 at the discretion of the clinical investigator.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Cyclophosphamide
1995
Completed Phase 3
~3770
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Jonsson Comprehensive Cancer CenterLead Sponsor
359 Previous Clinical Trials
26,008 Total Patients Enrolled
27 Trials studying Lymphoma
376 Patients Enrolled for Lymphoma
Parker Institute for Cancer ImmunotherapyOTHER
9 Previous Clinical Trials
416 Total Patients Enrolled
Anusha Kalbasi, MDPrincipal InvestigatorUCLA / Jonsson Comprehensive Cancer Center
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

CD19/CD20 CAR-T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04007029 — Phase 1
Lymphoma Research Study Groups: Treatment (fludarabine, cyclophosphamide, CD19/CD20 T-cells)
Lymphoma Clinical Trial 2023: CD19/CD20 CAR-T Cells Highlights & Side Effects. Trial Name: NCT04007029 — Phase 1
CD19/CD20 CAR-T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04007029 — Phase 1

Frequently Asked Questions

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

Are there any openings remaining for this experimental procedure?

"The details posted on clinicaltrials.gov demonstrate that this medical trial is still recruiting participants, having been initially publicized in October of 2019 and most recently updated on September 9th 2022."

Answered by AI

What conditions usually warrant the utilization of Cyclophosphamide?

"Cyclophosphamide is commonly prescribed to treat systemic juvenile idiopathic arthritis (sjia). Additionally, it has been seen as a potential therapeutic option for multiple sclerosis, leukemia, myelocytic acute and retinoblastoma patients."

Answered by AI

How many individuals have been enrolled in this experiment thus far?

"Affirmative. The information displayed on clinicaltrials.gov attests to the fact that this medical trial, initially posted on October 4th 2019 is currently accepting candidates. A total of 24 participants need to be sourced from a single location."

Answered by AI

Are there any precedential investigations that have employed Cyclophosphamide?

"As of now, Cyclophosphamide has 952 live clinical trials with 169 in Phase 3. Philadelphia, Pennsylvania is the epicentre for this drug's research but it is being tested at 29684 sites across the world."

Answered by AI

What are the deleterious effects of Cyclophosphamide usage?

"Our team at Power gave Cyclophosphamide a score of 1 as this is still in the early stages of testing. Data corroborating its safety and efficacy has not been fully established yet."

Answered by AI

What are the chief objectives of this medical experiment?

"Over the course of four weeks, this trial will measure adverse events and secondary outcomes including CAR T-cell 19/20 bispecific transgenic cell persistence, progression-free survival, and clinical response. Descriptive statistics such as mean, standard deviation, median etc., figures with Kaplan Meier estimates along with suitable plots for longitudinal data will be used to analyse these parameters."

Answered by AI

Are my credentials suitable for enrollment in this research?

"This study requires 24 participants who have suffered a relapse, aged 18 to 70. Qualifications include possessing one of the following conditions: DLBCL, PMBCL, MCL, FL, CLL or SLL that is resistant to standard treatments and having an ECOG performance status between 0-1."

Answered by AI

Are geriatric patients receiving treatments in this research study?

"This medical research endeavour is open to persons aged 18 and above, but below the age of 70."

Answered by AI
~1 spots leftby Aug 2024