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CAR T-cell Therapy
CLBR001 CAR-T for Non-Hodgkin's Lymphoma
Phase 1
Waitlist Available
Led By Carolyn Mulroney, M.D.
Research Sponsored by Calibr, a division of Scripps Research
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 15 years
Awards & highlights
No Placebo-Only Group
Summary
This trial involves monitoring patients who received a special cancer treatment using their own modified immune cells. These patients are followed for an extended period to check for safety and effectiveness. The treatment works by reprogramming the patient's immune cells to better fight cancer and has shown promising results.
Who is the study for?
This trial is for patients who have received at least one dose of CLBR001 CAR-T cells for various types of B-cell lymphomas and leukemias. Participants must be able to give informed consent and follow the study's visit schedule and requirements.
What is being tested?
The study follows up long-term with patients treated with genetically modified autologous CLBR001 CAR-T cells, possibly in combination with SWI019, to monitor ongoing effects after their initial treatment.
What are the potential side effects?
While specific side effects are not listed here, typical CAR-T therapy side effects can include cytokine release syndrome (flu-like symptoms), neurological events, low blood cell counts, infection risk increase, and infusion-related reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence and duration of new adverse events, late onset adverse events, and events of special interest
Incidence and duration of new serious adverse events
Incidence of new malignancies
+1 moreSecondary study objectives
Detectable replication competent lentivirus (RCL)
Duration of detection of ADA for CLBR001 and SWI019
Duration of response
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: CLBR001 treated patientsExperimental Treatment1 Intervention
Patients who have been administered with CLBR001
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CLBR001 and SWI019
2020
Completed Phase 1
~20
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Follicular Lymphoma include high-dose chemotherapy with autologous hematopoietic cell transplantation (HCT), nonmyeloablative or reduced intensity allogeneic HCT, and CAR-T cell therapy. High-dose chemotherapy with autologous HCT involves using high doses of chemotherapy to kill cancer cells, followed by the infusion of the patient's own stem cells to restore bone marrow function.
Nonmyeloablative or reduced intensity allogeneic HCT uses lower doses of chemotherapy and radiation to suppress the immune system, followed by the infusion of donor stem cells, which can attack remaining cancer cells. CAR-T cell therapy involves genetically modifying a patient's T cells to express chimeric antigen receptors (CARs) that specifically target and kill cancer cells.
This is particularly significant for Follicular Lymphoma patients as CAR-T cell therapy offers a targeted approach that can lead to long-term remissions, especially in cases where other treatments have failed.
Chimeric Antigen Receptor-T-Cell Therapy for B-Cell Hematological Malignancies: An Update of the Pivotal Clinical Trial Data.Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.
Chimeric Antigen Receptor-T-Cell Therapy for B-Cell Hematological Malignancies: An Update of the Pivotal Clinical Trial Data.Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies.New angles of attack in the fight against chronic lymphocytic leukemia: the advent of novel non-chemotherapeutic agents.
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Who is running the clinical trial?
Calibr, a division of Scripps ResearchLead Sponsor
6 Previous Clinical Trials
303 Total Patients Enrolled
Carolyn Mulroney, M.D.Principal InvestigatorUniversity of California, San Diego
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received at least one dose of CLBR001 cells and have either finished or stopped the treatment early.
Research Study Groups:
This trial has the following groups:- Group 1: CLBR001 treated patients
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.