CAR-T Cell Therapy: Challenges and Optimization.
Mei Luo, Hongchang Zhang, Linnan Zhu...
https://pubmed.ncbi.nlm.nih.gov/33822526Actively Recruiting
Phase 1
Age: 0 - 75Years
All Genders
ID01853631
Phase I Study of Activated T-Cells Expressing Second or Third Generation CD19-Specific Chimeric Antigen Receptors for Advanced B-Cell Non-Hodgkin's Lymphoma, Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia (SAGAN)
Led by Baylor College of Medicine · Updated on 2026-01-05
64
Participants Needed
2
Research Sites
478 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
C
Center for Cell and Gene Therapy, Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with certain blood cancers, including Non-Hodgkin Lymphoma, acute lymphocytic leukemia, and chronic lymphocytic leukemia, whose disease has returned or not responded to previous treatments. The study aims to test new immune therapies that combine antibodies and T cells to better fight these cancers. This research focuses on specially modified T cells that carry a receptor targeting CD19, a protein found on cancer cells, with added proteins to improve their effectiveness and persistence in the body. Participants will provide blood samples to create these modified T cells in the lab, where a virus is used to insert genes that produce the CD19 receptor along with stimulating proteins CD28, with or without CD137. Patients will receive infusions of these T cells at different doses, and some may receive chemotherapy beforehand to reduce their existing T cells and improve treatment effectiveness. If initial treatment shows benefit after six weeks, additional infusions may be offered at regular intervals. During the study, patients will be closely monitored for side effects, how long the modified T cells last, and any signs of cancer response. Follow-up includes blood tests and clinical exams, with long-term monitoring for up to 15 years to detect any lasting effects of the gene therapy. The main goal is to find the highest safe dose and understand the treatment's impact on the cancer and patient safety.
CONDITIONS
Brief Title
Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)
Who Can Participate
Age: 0 - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent B-cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy, or relapsed/refractory aggressive B-cell lymphoma planned for high dose therapy and stem cell transplant
- CD19-positive tumor (result may be pending at initial screening)
- Age 18 to 75 years
- Hemoglobin level of 7.0 or higher (transfused value allowed)
- For blood collection: creatinine less than 1.5 times upper normal limit, AST less than 1.5 times upper normal limit, PT and APTT less than 1.5 times upper normal limit
- Informed consent signed and understood by patient or guardian
- Bilirubin less than 3 times upper normal limit
- AST less than 5 times upper normal limit
- Estimated glomerular filtration rate (GFR) greater than 50 mL/min
- Oxygen saturation above 90% on room air
- Karnofsky or Lansky performance score above 60%
- Recovered from acute effects of prior chemotherapy at least one week before study entry
- Available activated T cell products with at least 15% CD19.CAR expression
- Life expectancy greater than 12 weeks
- Sexually active patients agree to use effective birth control during and 6 months after study
- Signed informed consent acknowledging study risks and benefits
You will not qualify if you...
- Active infection requiring antibiotics
- History of other cancers except non-melanoma skin cancer or in situ breast/cervix cancer treated curatively at least 2 years prior
- Currently receiving investigational agents or tumor vaccines within 6 weeks (PD1/PDL1 inhibitors allowed)
- History of allergic reactions to murine protein-containing products
- Pregnant or breastfeeding
- Tumor location causing potential airway obstruction if enlarged
- Active infection with HIV or HTLV
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Initial infusion plus up to five additional doses over several months, with at least 6 weeks before the first repeat infusion and at least 4 weeks between subsequent infusions
Participants receive an infusion of CD19 CAR T cells at an assigned dose. Some participants may receive chemotherapy before infusion to reduce their own T cells. After the first infusion, participants may receive up to five additional infusions if they show benefit, with intervals of at least 6 weeks before the first repeat and 4 weeks between subsequent doses.
1 infusion visit with up to 3 hours of observation after each infusion; additional infusion visits spaced by at least 4 to 6 weeks
Long-term Monitoring
Duration - Up to 15 years
Participants are followed for up to 15 years to monitor for long-term side effects of gene transfer and to assess the survival and function of the infused T cells.
Periodic visits or contacts by research staff over 15 years; some visits may be remote
Trial Site Locations
Total: 2 locations
1
Houston Methodist Hospital
Houston, Texas, United States, 77030
Actively Recruiting
2
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
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Research Team
C
Carlos A Ramos, MD
M
Mahshid Azamian
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
4
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