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CAR T-cell Therapy
CAR T-Cell Therapy for Chronic Lymphocytic Leukemia
Phase 1 & 2
Recruiting
Led By Jennifer N Brudno, 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 up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to test a new treatment called anti-CD19 CAR T cell therapy for people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Who is the study for?
This trial is for adults over 18 with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that hasn't responded to standard treatments. Participants must have a tumor sample available for CD19 testing, and their heart and overall health should be stable enough to undergo the procedures involved in the trial.
What is being tested?
The study tests anti-CD19 CAR T cell therapy, where patients' own immune cells are modified to target cancer cells. It involves taking medication to reduce leukemia cells, extracting T cells from blood, genetically modifying them in a lab, and then infusing them back into the patient's bloodstream.
What are the potential side effects?
Possible side effects include reactions related to infusion of modified T-cells such as fever, fatigue, headache; complications due to gene editing like abnormal immune responses; and effects from preparatory drugs including nausea and hair loss.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Phase I: Determine the safety of administering T-cells expressing a fully-human anti-CD19 CAR to participants with advanced CLL or SLL.
Phase II: Determine the overall response rate (ORR) of T cells expressing an anti-CD19 CAR with a fully-human single chain variable fragment (scFv) to participants with advanced CLL
Secondary study objectives
Phase I+II: Assess complete response rate
Phase I+II: Assess duration of responses
Phase I+II: Determine the ORR for re treatment with rituximab, chemotherapy and CAR T cells in eligible patients
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose expansionExperimental Treatment4 Interventions
MTD dose or Optimal dose of Anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy
Group II: 1/Rituximab, conditioning chemotherapy plus CAR T-cells- Dose escalationExperimental Treatment4 Interventions
Escalating dose of anti-CD19 CAR T- cells/kg + rituximab and conditioning chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Fludarabine
2012
Completed Phase 4
~1860
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,957 Previous Clinical Trials
41,112,515 Total Patients Enrolled
1,411 Trials studying Lymphoma
383,768 Patients Enrolled for Lymphoma
Jennifer N Brudno, M.D.Principal InvestigatorNational Cancer Institute (NCI)