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CAR T-cell Therapy
CAR-T Therapy for B-Cell Lymphoma
Phase 1
Recruiting
Led By Marcus Butler, M.D.
Research Sponsored by University Health Network, Toronto
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 one year
Awards & highlights
Study Summary
This trial studies the safety & effects of a CAR-T therapy for relapsed/refractory B-cell lymphoma/CLL/SLL.
Who is the study for?
This trial is for adults over 18 with CD19+ B-cell Lymphoma, CLL, or SLL who've had at least two prior treatments. They should be in good health with a life expectancy of more than 4 months and have not received cancer treatment within the last two weeks. Pregnant women, those with certain medical conditions or history of organ transplant requiring immunosuppression are excluded.Check my eligibility
What is being tested?
The study tests TBI-2001 (a CAR-T therapy targeting CD19) along with Cyclophosphamide and Fludarabine in patients whose disease returned after treatment or didn't respond to previous therapies. It's an early-phase trial to check safety and effectiveness, gradually increasing doses to find the right amount.See study design
What are the potential side effects?
Potential side effects include immune system reactions that can affect normal cells leading to symptoms like fever, fatigue, breathing difficulties; there may also be risks from chemotherapy drugs used such as nausea, hair loss, and increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase 2 dose (RP2D) of TBI-2001
Safety of TBI-2001
Secondary outcome measures
Efficacy of TBI-2001; Durable Response Rate (DRR)
Efficacy of TBI-2001; Overall Response Rate (ORR)
Efficacy of TBI-2001; Overall survival (OS)
+1 moreOther outcome measures
Minimal residual disease (MRD) negative rate (in CLL patients)
Persistence of TBI-2001
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: Dose Level 1 to 3Experimental Treatment3 Interventions
0.3 to 3 x 10^6 autologous CD19-CAR-T cells/kg per patient will be administered intravenously after a conditioning chemotherapy with cyclophosphamide and fludarabine.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,476 Previous Clinical Trials
485,161 Total Patients Enrolled
Takara Bio Inc.Industry Sponsor
13 Previous Clinical Trials
249 Total Patients Enrolled
Marcus Butler, M.D.Principal InvestigatorPrincess Margaret Cancer Centre
3 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any cancer except skin cancer in the last 2 years.I have B cell cancer and have had at least 2 treatments before.I haven't taken immunosuppressive drugs in the last 14 days.I have an untreated active tuberculosis infection.I am HIV positive.I do not have active hepatitis B or C, confirmed by a negative PCR test.I have brain metastases that haven't been treated yet.My doctor thinks my condition can't be cured and I might need TBI-2001 treatment soon.I have had an autoimmune disease in the last 2 years.I haven't had cancer treatments like chemo, radiation, or immunotherapy in the last 2 weeks.My vital organs are functioning well.I have received a stem cell transplant from a donor.I have had an organ transplant and take drugs to suppress my immune system.I am 18 years old or older.I am fully active or restricted in physically strenuous activity but can do light work.I have received treatment targeting CD19 before.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Dose Level 1 to 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical trial open to enrollment as of now?
"Affirmative. Information posted to clinicaltrials.gov reports that this investigation is actively in the process of recruiting volunteers, with 19 participants needed at 1 facility. The study was initially published on July 26th 2023 and had its last revision then as well."
Answered by AI
What are the overarching aims of this exploration?
"This clinical study seeks to ascertain the Recommended phase 2 dose (RP2D) of TBI-2001 over a 12 month period. Secondary objectives include assessing Efficacy, Durable Response Rate (DRR), Progression Free Survival (PFS) and Overall Survival (OS)."
Answered by AI
What is the aggregate amount of participants registered for this clinical investigation?
"Affirmative, based on the clinicaltrials.gov information this trial is presently recruiting participants. The research program was initially published on July 26th 2023 and has been revised since then. It seeks to enroll 19 people at a single medical facility."
Answered by AI
What risks are involved with administering dose levels one through three of this experimental drug?
"The safety of Experimental: Dose Level 1 to 3 is assessed as a '1' because this phase one trial has only limited evidence in terms of both efficacy and safety."
Answered by AI
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