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CAR T-cell Therapy

Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells for B-Cell Lymphoma

Phase 1
Waitlist Available
Led By James N Kochenderfer, M.D.
Research Sponsored by National Cancer Institute (NCI)
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 response duration is the time from first documentation of response, which is one month after cell infusion in all participants, until progression, initiation of off-study treatment or the last documentation on ongoing response, approx. one month -5 years.
Awards & highlights

Study Summary

This trial is testing the safety of giving T cells that have been modified to express a novel fully-human anti-CD19 chimeric antigen receptor to people with advanced B-cell cancer.

Eligible Conditions
  • B-Cell Lymphoma
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~participants could receive subsequent cell infusions any time 1 month after car t-cell infusion until 5 years after cell infusion.
This trial's timeline: 3 weeks for screening, Varies for treatment, and participants could receive subsequent cell infusions any time 1 month after car t-cell infusion until 5 years after cell infusion. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Enrolled Participants Who Actually Get Treated
Secondary outcome measures
Median Peak Chimeric Antigen Receptor (CAR) T Cells Level for Participants Treated
Number of Participants That Had Any Grade 2, 3, 4 and 5 Adverse Events
Number of Participants Who Had Anti-Lymphoma Activity
+4 more
Other outcome measures
MTD
Maximum Feasible Dose
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
+1 more

Side effects data

From 2022 Phase 1 trial • 27 Patients • NCT02659943
100%
Aspartate aminotransferase increased
100%
Hypotension
100%
Lymphocyte count decreased
100%
Neutrophil count decreased
100%
Anemia
100%
Fever
100%
White blood cell decreased
67%
Syncope
67%
Hypoalbuminemia
67%
Hypophosphatemia
67%
Pleural effusion
67%
Dyspnea
67%
Nausea
67%
Alanine aminotransferase increased
67%
Electrocardiogram QT corrected interval prolonged
67%
Upper respiratory infection
33%
Confusion
33%
Generalized muscle weakness
33%
Tremor
33%
Activated partial thromboplastin time prolonged
33%
Bloating
33%
Bone pain
33%
Chills
33%
Hyponatremia
33%
Lung infection
33%
Pericardial effusion
33%
Thromboembolic event
33%
Vaginal dryness
33%
Hypertension
33%
Mucosal infection
33%
Nasal congestion
33%
Conjunctivitis infective
33%
Cough
33%
Gastroesophageal reflux disease
33%
Hiccups
33%
Hypoxia
33%
Presyncope
33%
Sinus tachycardia
33%
Back pain
33%
Fatigue
33%
Encephalopathy
33%
Supraventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells Only
LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T Cells
LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells
LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells Only
LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells Only
LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T Cells

Trial Design

6Treatment groups
Experimental Treatment
Group I: LEVEL 3 - Participants Who Received 6x10^6 CAR T Cells OnlyExperimental Treatment1 Intervention
LEVEL 3 - participants who received - 6x10^6 Chimeric Antigen Receptor (CAR) T cells only
Group II: LEVEL 2 Followed by LEVEL 3-Participants Who Received 2x10^6 CAR T Cells Foll/by 6x10^6 CAR T CellsExperimental Treatment3 Interventions
LEVEL 2 followed by LEVEL 3 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
Group III: LEVEL 2 - Participants Who Received 2x10^6 CAR T Cells OnlyExperimental Treatment1 Intervention
LEVEL 2 - participants who received - 2x10^6 Chimeric Antigen Receptor (CAR) T cells only
Group IV: LEVEL 1 Foll/by LEVEL 3 - Participants Who Received 0.66x10^6 CAR T Cells Foll/by 6x10^6 CAR T CellsExperimental Treatment3 Interventions
LEVEL 1 followed by LEVEL 3 - participant who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 6x10^6 CAR T cells
Group V: LEVEL 1 Foll/by LEVEL 2-Participants Who Received - 0.66x10^6 CAR T Cells Foll/by 2x10^6 CAR T CellsExperimental Treatment3 Interventions
LEVEL 1 followed by LEVEL 2 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells followed by 2x10^6 CAR T cells
Group VI: LEVEL 1 - Participants Who Received 0.66x10^6 CAR T Cells OnlyExperimental Treatment1 Intervention
LEVEL 1 - participants who received - 0.66x10^6 Chimeric Antigen Receptor (CAR) T cells only
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells
2016
Completed Phase 1
~30
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,664 Previous Clinical Trials
40,926,106 Total Patients Enrolled
James N Kochenderfer, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
1,249 Total Patients Enrolled

Frequently Asked Questions

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

Has research been conducted on Anti-CD19-CAR T cells previously?

"Currently, 889 different medical trials are researching Anti-CD19 Chimeric Antigen Receptor (CAR) T cells; of these, 161 have progressed to Phase 3. The principal source for this research is Philadelphia, Pennsylvania yet there exists 28443 sites offering clinical studies on the subject."

Answered by AI

Are individuals below the age of 75 allowed to partake in this experimental study?

"This trial is open to applicants aged 18 to 73. Additionally, 888 studies are tailored for those younger than the age of consent and 4348 specifically target participants over 65 years old."

Answered by AI

Are there any vacancies in this clinical investigation available for participants?

"The data hosted on clinicaltrials.gov is clear: this medical trial, which was initially posted in January 2016 and last updated April 2022, is not currently looking for participants. Fortunately, there are many other trials that have open recruitment at present - 4885 to be exact."

Answered by AI

Has the FDA given approval to Anti-CD19 CAR T cells?

"This experimental technology was assigned a value of 1 due to the restricted amount of data available concerning its safety and efficacy, as this is only in the first phase of testing."

Answered by AI

What diseases can be treated with Anti-CD19-CAR T cell therapy?

"Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells are often prescribed to treat multiple sclerosis, but have also been demonstrated as a viable option for mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."

Answered by AI

How many people have registered for the trial thus far?

"This trial has already concluded its recruitment phase. Initially posted on January 21st 2016, the last update was made April 25th 2022. Presently there are 3996 medical studies looking for lymphoma and B-cell participants, plus 889 trials recruiting Anti-CD19 CAR T cell candidates."

Answered by AI

Who is eligible to enroll in this research study?

"Eligible for this trial are individuals between 18 and 73 years old suffering from b-cell lymphoma. A maximum of 27 patients is required to be enrolled in the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies
James Kochenderfer, M.D. 2016. "T Cells Expressing a Fully-human AntiCD19 Chimeric Antigen Receptor for Treating B-cell Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02659943.
~3 spots leftby Apr 2025
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