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CAR T-cell Therapy

CAR T-Cell Therapy + Ibrutinib for Chronic Lymphocytic Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
IPI score of 3, 4 or 5
MYC and BCL2 and/or BCL6 rearrangement (DH/THL)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up months 6, 12
Awards & highlights

Study Summary

This trial will study if it is safe to give patients autologous T cells that have been genetically engineered with a CD19-specific CAR, in combination with ibrutinib, for the treatment of CLL/SLL and as a single agent for the treatment of DLBCL and adult ALL.

Who is the study for?
This trial is for adults with certain blood cancers like CLL, SLL, DLBCL, and ALL. Participants must be in stable condition or partial remission after previous treatments (like ibrutinib for CLL/SLL), have not had prior CD19-directed therapy or genetically engineered cellular products, and can't have specific types of lymphoma or active CNS involvement.Check my eligibility
What is being tested?
The study tests Rapcabtagene autoleucel alone or with Ibrutinib on different blood cancers. It's to see if it's safe and effective. Phase I checks feasibility; phase II assesses how well the treatment works against these cancers.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related symptoms, fatigue, fever, chills, breathing difficulties, changes in blood pressure and heart rate. Specific side effect profiles will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My IPI score is between 3 and 5.
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My cancer has specific genetic changes in MYC, BCL2, or BCL6.
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My leukemia has returned or didn't respond to treatment and tests positive for CD19.
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My CLL/SLL is stable or improving after 6+ months on ibrutinib.
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I have been diagnosed with CLL or SLL.
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I am fully active or can carry out light work.
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My leukemia is present in my bone marrow.
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I have completed 2 cycles of initial treatment for large B-cell lymphoma.
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My DLBCL has not improved after at least 2 treatments, including a stem cell transplant.
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My diagnosis is diffuse large B-cell lymphoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~months 6, 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and months 6, 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1: Dose recommendation: Incidence and nature of Dose Limiting Toxicities (Dose Escalation part only)
Phase 1: Manufacture success: Number of patients infused with planned target dose
Phase 1: Safety: Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs
+2 more
Secondary outcome measures
Phase 1/2: Cellular kinetics
Phase 1/2: Immunogenicity
Phase 1: BOR in ALL as assessed by an Independent Review Committee (IRC)
+25 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: CLL/SLLExperimental Treatment2 Interventions
Dose escalation and expansion of rapcabtagene autoleucel in combination with ibrutinib
Group II: Adult ALLExperimental Treatment1 Intervention
Dose escalation and expansion of rapcabtagene autoleucel single agent in adult ALL
Group III: 3L+ DLBCLExperimental Treatment1 Intervention
Dose escalation and expansion of rapcabtagene autoleucel single agent in 3L+ DLBCL
Group IV: 1L HR LBCLExperimental Treatment1 Intervention
Rapcabtagene autoleucel single agent in 1L HR LBCL
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibrutinib
2014
Completed Phase 3
~1880

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,856 Previous Clinical Trials
4,197,480 Total Patients Enrolled

Media Library

YTB323 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03960840 — Phase 1 & 2
Chronic Lymphocytic Leukemia Clinical Trial 2023: YTB323 Highlights & Side Effects. Trial Name: NCT03960840 — Phase 1 & 2
YTB323 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03960840 — Phase 1 & 2
Chronic Lymphocytic Leukemia Research Study Groups: 3L+ DLBCL, Adult ALL, 1L HR LBCL, CLL/SLL

Frequently Asked Questions

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

What risk factors are associated with YTB323 if used as an individual treatment?

"Our experts at Power have assigned YTB323 single agent a score of 1, as Phase 1 trials are limited in their ability to assess safety and efficacy."

Answered by AI

What other research has been performed with the YTB323 single agent?

"YTB323 single agent was initially experimented on at the National Institutes of Health Clinical Center, 9000 Rockville Pike in 2011. 96 clinical studies have been successfully completed with additional 155 trials actively recruiting; many of these being conducted out of Tampa, Florida."

Answered by AI

What is the patient enrollment for this clinical investigation?

"Right. The clinical trial is still ongoing and recruiting participants, as indicated on the website of clinicaltrials.gov. This experiment was first published on June 27th 2019, with edits being made most recently at February 24th 2022. It requires 110 individuals from 7 distinct sites to partake in it."

Answered by AI

Are there numerous locations in this city providing access to the experiment?

"Seven healthcare facilities are currently conducting this trial. These sites can be found in Tampa, Philadelphia and Milwaukee as well as four other cities. To reduce travel demands for participants, it is recommended to select a location closest to your home."

Answered by AI

Is this medical research accepting participants at present?

"Correct. The clinical trial's records on clinicaltrials.gov affirm that this experiment is presently recruiting volunteers, with the first post being made on June 27th 2019. 110 individuals are needed from 7 different sites to complete the study, which was most recently updated February 24th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL
2019. "Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03960840.
~89 spots leftby Jun 2027
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