Your session is about to expire
← Back to Search
CAR T-cell Therapy
CD19.CAR-aNKT Cells for Lymphoma and Leukemia
Phase 1
Recruiting
Led By Carlos Ramos, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 3 and ≤75 years.
Cohort B (ALL patients): Relapsed or refractory after two or more lines of therapy, if ALL.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks post t cell infusion
Awards & highlights
Study Summary
This trial is for patients with lymphoma or leukemia that has come back or has not gone away after treatment. Because there is no standard treatment for this cancer, patients are being asked to volunteer for a gene transfer research study using special immune cells.
Who is the study for?
This trial is for people aged 3-75 with certain types of B-cell lymphoma or leukemia that have CD19 on their surface and have not responded to treatment. They must be in relatively good health, with proper liver and kidney function, no severe infections, and a reasonable life expectancy. Participants need to agree to use effective birth control during the study.Check my eligibility
What is being tested?
The trial tests ANCHOR cells (CD19.CAR-aNKT), which are genetically modified immune cells designed to fight cancer by targeting CD19 on tumor cells. The goal is to determine the highest safe dose, how long these cells last in the body, their side effects, and if they help treat lymphoma or leukemia.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune response such as fever or fatigue; risk of infection; possible allergic reactions due to protein components from mice used in cell modification; and other typical risks associated with infusion therapies.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 3 and 75 years old.
Select...
My ALL has not responded to at least two treatments.
Select...
I have been diagnosed with a type of blood cancer that tests positive for CD19.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
My kidney function is good.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 weeks post t cell infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks post t cell infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity (DLT) rate
Secondary outcome measures
Frequency of circulating CD19.CAR-aNKT cells transduced with the vector.
Overall response rate according to the Lugano criteria for non-Hodgkin lymphomas (for NHL) and the IWG (for CLL), or the proportion of patients with morphologic CR (for ALL).
Trial Design
2Treatment groups
Experimental Treatment
Group I: CD19.CAR-aNKT cells (cohort B, ALL).Experimental Treatment1 Intervention
This cohort is for patients with refractory/relapsed B-cell NHL or leukemia (ALL). Three dose levels will be evaluated. Patients will also receive lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by the CD19.CAR-aNKT cell infusion.
Group II: CD19.CAR-aNKT cells (cohort A, non-ALL)Experimental Treatment1 Intervention
This cohort is for patients without refractory/relapsed B-cell NHL or leukemia (ALL). Three dose levels will be evaluated. Patients will also receive lymphodepletion chemotherapy consisting of cyclophosphamide and fludarabine followed by the CD19.CAR-aNKT cell infusion.
Find a Location
Who is running the clinical trial?
The Methodist Hospital Research InstituteOTHER
271 Previous Clinical Trials
80,327 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,769 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,204 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 3 and 75 years old.I have been diagnosed with a type of blood cancer that tests positive for CD19.My ALL has not responded to at least two treatments.I have recovered from the major side effects of my previous chemotherapy.I have had a moderate to severe reaction from a transplant.I am not currently on experimental drugs or had cell therapy in the last 6 weeks.You are expected to live for at least 3 months (12 weeks).I am mostly able to care for myself and carry out daily activities.My lymphoma has not responded to at least two treatments, including specific drugs based on its type.I do not have any untreated serious infections.I agree to use effective birth control during and for 6 months after the study.You have had allergic reactions to products that contain murine protein (proteins from mice).I do not have an active HIV or HTLV infection.My kidney function is good.I have an active hepatitis B or C infection.
Research Study Groups:
This trial has the following groups:- Group 1: CD19.CAR-aNKT cells (cohort B, ALL).
- Group 2: CD19.CAR-aNKT cells (cohort A, non-ALL)
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.
Are there any openings left in this trial?
"According to the clinicaltrials.gov database, this medical study is presently in its recruitment phase. Initially published on June 22nd 2020 and most recently updated on August 19th 2022."
Answered by AI
Is the age range for this experiment restricted to those under 40 years old?
"This trial has established that the youngest eligible patient is three years old, while the oldest can be 75."
Answered by AI
To what degree are CD19.CAR-aNKT cells deemed safe for individuals?
"Our experts at Power have rated CD19.CAR-aNKT cells as 1 on a 3-point scale, given the early stage of development and limited available data regarding safety and efficacy."
Answered by AI
Has CD19.CAR-aNKT been scientifically evaluated in past research studies?
"As of the present day, 889 studies that involve CD19.CAR-aNKT cells are occurring, with 161 trials in Phase 3 specifically. Philadelphia is one hub for such research; however, 28443 centres all over the country have been running clinical trials on this topic as well."
Answered by AI
What medical applications does CD19.CAR-aNKT cells have?
"CD19.CAR-aNKT cells are routinely utilized to alleviate the symptoms of multiple sclerosis, but have also been used with some success in cases of mixed-cell type lymphoma, acute leukemia, myelocytic cancer, and retinoblastoma."
Answered by AI
What is the scope of participants in this clinical investigation?
"Affirmative. The clinicaltrials.gov listing states that the trial, first posted on June 22nd 2020, is actively recruiting participants. In total, 48 patients need to be found between two medical centres."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger