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CAR T-cell Therapy

CAR-T Cell Therapy for B-Cell Lymphoma

Phase 1
Recruiting
Led By Natalie Grover, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must have received specific prior lines of therapy based on lymphoma subtype
Karnofsky score of > 60%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines T cells and antibodies to create a more effective treatment than either alone. So far it has caused side effects including cytokine release syndrome and neurotoxicity, but the goal is to find a dose of the second study drug, AP1903, that reduces the severity of the cytokine release syndrome and/or neurotoxicity, but still allows the remaining iC9-CAR19 cells to effectively fight the lymphoma.

Who is the study for?
This trial is for adults over 18 with certain types of B-cell lymphoma or leukemia who have tried at least two other treatments without success. It's not for pregnant women, those with severe hepatitis B, or HIV/HTLV/HCV infections. Participants must be willing to use birth control and have a Karnofsky score above 60%, indicating they can care for themselves.Check my eligibility
What is being tested?
The study tests iC9-CAR19 T cells designed to target CD19 on cancer cells, combined with chemotherapy drugs like Bendamustine and Fludarabine. If severe side effects occur, AP1903 is used to activate a 'safety switch' in the T cells to reduce their activity.See study design
What are the potential side effects?
Potential side effects include cytokine release syndrome (a rapid release of cytokines into the blood) and neurotoxicity (damage to nerve tissue). The safety switch aims to mitigate these by deactivating some T cells if necessary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received treatments specific to my type of lymphoma.
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I am able to care for myself but may not be able to do active work.
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My diagnosis is B-cell Non-Hodgkin Lymphoma.
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My lymphoma has spread to my brain or spinal cord.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Number of participants with adverse events as a measure of safety and tolerability of iC9-CAR19 T cells
Secondary outcome measures
Change in health related quality of life
Change in patient-reported symptoms
Change in physical function
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Arm iC9.CAR19 T cellsExperimental Treatment5 Interventions
The safety of iC9-CAR19 cells will be investigated using the 3+3 design. Dose level (DL) Dose (#transduced cells/kg) -1 1 x 10^5 1 x 10^6 2 x 10^6 DL1 will enroll 3 subjects. If no toxicity within 4 weeks, then DL 2 will enroll 3 subjects. If toxicity in 1/3 subjects in DL 1, 3 more subjects will be enrolled. If DL 1 is not tolerable, a de-escalation to DL -1 will enroll 3 subjects. If 3 subjects at the higher dose do not have DLTs more will be enrolled at that dose to get more information about toxicity. Lymphodepleting chemotherapy of IV bendamustine 70 mg/m2 and IV fludarabine 30 mg/m2/day for 3 consecutive days will be given within 2-14 days prior to cell infusion. AP1903 (0.4 mg/kg), a dimerizing agent to engage and activate the caspase 9 safety switch to trigger iC9-CAR19 T cell death by apoptosis will be given to subjects who develop severe cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).
Group II: Expansion Cohort iC9-CAR19 cellsExperimental Treatment5 Interventions
After the tolerable cell dose (TCD) has been determined in adults, up to 18 additional subjects may be enrolled in an expansion cohort at the TCD. A TCD is defined as the dose at which approximately 0.20 of subjects experience dose limiting toxicity (0 - 1 out of 6 subjects).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine
2015
Completed Phase 3
~2950
Fludarabine
2012
Completed Phase 3
~1100
AP1903
2014
Completed Phase 2
~90
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Bellicum PharmaceuticalsIndustry Sponsor
26 Previous Clinical Trials
1,280 Total Patients Enrolled
The V FoundationOTHER
6 Previous Clinical Trials
139 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
348 Previous Clinical Trials
88,141 Total Patients Enrolled

Media Library

iC9-CAR19 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03696784 — Phase 1
B-Cell Lymphoma Research Study Groups: Single Arm iC9.CAR19 T cells, Expansion Cohort iC9-CAR19 cells
B-Cell Lymphoma Clinical Trial 2023: iC9-CAR19 T cells Highlights & Side Effects. Trial Name: NCT03696784 — Phase 1
iC9-CAR19 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03696784 — Phase 1

Frequently Asked Questions

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

Could you elucidate any other experiments involving iC9-CAR19 T cells?

"Currently, there are 958 clinical trials researching the efficacy of iC9-CAR19 T cells. Out of those studies, 176 have reached Phase 3 and a majority of them can be found in Philadelphia pa; however, 32557 locations total are running these trial investigations."

Answered by AI

Is the utilization of iC9-CAR19 T cells potentially perilous for individuals?

"The limited clinical evidence for the safety and efficacy of iC9-CAR19 T cells has resulted in a score of 1 on our team's scale."

Answered by AI

Is this research endeavor currently recruiting participants?

"According to clinicaltrials.gov, this medical experiment is currently seeking volunteers. This trial was initially announced on March 12th 2019 and the most recent edit took place on December 2nd 2021."

Answered by AI

In what conditions is iC9-CAR19 T cell therapy employed?

"iC9-CAR19 T cells have been prescribed to patients with multiple sclerosis and other illnesses, including acute myelocytic leukemia, retinoblastoma, and multiple myeloma."

Answered by AI

What is the current sample size of participants receiving treatment in this research?

"Affirmative. Clinicaltrials.gov's data shows that the trial, which was initially posted on March 12th 2019, is presently seeking patients. The study aims to recruit 30 individuals from a single medical centre."

Answered by AI
~11 spots leftby Mar 2027