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CAR T-cell Therapy
CAR T-cell Therapy for Leukemia
Phase 1
Recruiting
Led By James N Kochenderfer, 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
Study Summary
This trial tests a new treatment using modified immune cells to fight B-cell cancers in adults ages 18-75. Patients receive chemo, T cells, and long-term follow-up.
Who is the study for?
Adults aged 18-75 with B-cell cancers uncontrolled by standard therapies can join. They must have tried certain treatments depending on their cancer type, and it's been enough time since those treatments. People with HIV, other active infections or malignancies, severe allergies to trial drugs, or who are pregnant/breastfeeding cannot participate.Check my eligibility
What is being tested?
The trial tests a new therapy using the patient's own T cells modified with genes (CAR T cells) targeting CD19/CD20 to fight B-cell cancers. It includes chemotherapy drugs Cyclophosphamide and Fludarabine before infusing the CAR T cells back into the patient.See study design
What are the potential side effects?
Possible side effects include reactions at infusion sites, increased risk of infection due to weakened immune system from chemotherapy, potential organ inflammation from CAR T-cells, fatigue, nausea from chemo drugs and possibly fever or chills.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the safety and feasibility of administering T cells expressing a novel fully-human anti-CD19 and anti-CD20 CAR construct to patients with advanced B-cell malignancies.
Secondary outcome measures
Assess complete response rate
Assess duration of responses
Assess overall response rate
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/Conditioning chemotherapy plus CAR T-cells expansion phaseExperimental Treatment3 Interventions
MTD dose or Optimal dose of Anti-CD19 and anti-CD20 CAR T- cells/kg + conditioning chemotherapy
Group II: 1/Conditioning chemotherapy plus CAR T-cells dose escalationExperimental Treatment3 Interventions
Escalating dose of anti-CD19 and anti-CD20 CAR T- cells/kg + conditioning chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine
2012
Completed Phase 3
~1080
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,703 Previous Clinical Trials
40,931,692 Total Patients Enrolled
James N Kochenderfer, M.D.Principal InvestigatorNational Cancer Institute (NCI)
8 Previous Clinical Trials
1,218 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection that is not under control.I do not have active hemolytic anemia, HIV, HTLV, Babesia, West Nile virus, T. Cruzi, or a positive RPR test.I am on blood thinners other than aspirin.I have active cancer spread to my brain or in my cerebrospinal fluid.I have not taken checkpoint inhibitor drugs recently.I do not have any uncontrolled bleeding disorders or major illnesses.It has been over 2 weeks since my last systemic treatment before my scheduled cell therapy.I have another cancer besides my B-cell malignancy, but it meets the trial's exceptions.I haven't had anti-CD20 or anti-CD19 treatments in the last 60 days.I haven't taken high doses of steroids in the last 2 weeks.I meet the age, health, and treatment history requirements.I have Burkitt lymphoma and have undergone at least one chemotherapy treatment.My lymphoma has been treated with at least 2 prior therapies.I have Waldenstrom's macroglobulinemia/lymphoma and was treated with specific therapies.My lymphoma type meets the specific trial criteria.I have CLL or small lymphocytic lymphoma and my condition has worsened after treatment.It has been over 60 days since my last CD19 or CD20 antibody therapy or CAR T-cell treatment.My cancer is a type of B-cell malignancy.I have DLBCL and have undergone at least two prior treatments.My lymphoma cells show CD19 or CD20.I need urgent treatment because my tumor is pressing on my spine or other organs.I have mantle cell lymphoma and have undergone specific treatments.It has been over 6 months since my last CAR T-cell therapy.I have follicular lymphoma and have undergone at least 2 prior treatments.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Conditioning chemotherapy plus CAR T-cells dose escalation
- Group 2: 2/Conditioning chemotherapy plus CAR T-cells expansion phase
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.
Who meets the eligibility criteria to participate in this medical trial?
"To be eligible for the trial, individuals must posses chronic lymphocytic leukemia and span an age range of 18 to 75 years old. The necessary number of participants needed is 58 people."
Answered by AI
Does this research project include individuals aged fifty or older?
"This trial is open to those aged 18 through 75. Separately, there are 485 clinical trials for minors and 1618 specifically geared towards the elderly population."
Answered by AI
How would you rate the risk associated with escalating doses of conditioning chemotherapy and CAR T-cells for patients?
"The safety of 1/Conditioning chemotherapy combined with CAR T-cells dose escalation is rated a 1 on the scale, as this is an early research stage and there are only limited data points to support its efficacy."
Answered by AI
Are there any unfilled slots available for participants in this study?
"The details on clinicaltrials.gov suggest that this particular trial is no longer actively enrolling patients; the initial post date was April 13th 2023 with the last update occurring a week later. However, there are still 1937 other trials offering enrollment right now."
Answered by AI
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