Allogeneic CD7-CAR T cells to bridge the gap?
M Paulina Velasquez
https://pubmed.ncbi.nlm.nih.gov/36858787Actively Recruiting
Phase 1
Age: 0 - 75Years
All Genders
ID03690011
Cell Therapy for High Risk T-cell Malignancies Using CD7-Specific CAR Expressed on Non-Edited T Cells (CRIMSON-NE)
Led by Baylor College of Medicine · Updated on 2025-10-23
27
Participants Needed
2
Research Sites
730 weeks
Total Duration
On this page
Sponsors
B
Baylor College of Medicine
Lead Sponsor
T
The Methodist Hospital Research Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate a new cell therapy for patients with high-risk T-cell blood cancers, including T-cell acute lymphoblastic leukemia, lymphoma, and other related T-cell malignancies. The study focuses on combining antibodies and T cells to better fight the cancer, using a specially modified antibody called anti-CD7 that targets cancer cells. This antibody is attached to T cells, creating chimeric receptor T cells that are designed to last longer and work more effectively against the cancer. These engineered cells are investigational and not yet approved by the FDA. To prepare the treatment, investigators will collect blood from patients and grow T cells in the lab, inserting the anti-CD7 gene using a specially designed retrovirus. Before receiving the modified T cells, patients will undergo chemotherapy with cyclophosphamide and fludarabine to reduce their own T cells and make room for the new cells to grow. Patients will receive one of four doses of the CD7 chimeric receptor T cells through an intravenous injection after these preparatory steps. Treatment and follow-up will occur at specialized centers, with patients monitored closely during and after infusion. Participants will undergo various medical tests before, during, and after treatment, including physical exams, blood tests, tumor measurements by scans or bone marrow studies, and heart ultrasound if needed. Blood samples will be taken multiple times over 15 years to study how long the modified T cells last in the body and to monitor for long-term effects. Patients are required to stay near the treatment center for at least three weeks post-infusion and may be hospitalized if side effects occur. The main outcomes measured include treatment safety within four weeks and overall response rate.
CONDITIONS
Brief Title
Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells
Who Can Participate
Age: 0 - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of recurrent or refractory T-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic lymphoma, or T-non-Hodgkin lymphoma including specified subtypes
- Suitable for allogeneic hematopoietic stem cell transplant with a suitable donor identified
- Willing to proceed to transplant if complete remission is achieved and candidates remain suitable
- CD7-positive tumor with 20% or more CD7 positive blasts confirmed by flow cytometry or pathology
- Age 18 to 75 years
- Hemoglobin level of 7.0 or higher (transfusion allowed)
- Life expectancy greater than 12 weeks
- If pheresis required, creatinine less than 1.5 times upper limit normal, AST less than 5 times upper limit normal, PT and APTT less than 1.5 times upper limit normal
- Bilirubin less than 3 times upper limit normal
- Estimated glomerular filtration rate (GFR) 50 mL/min or higher
- Pulse oximetry above 90% on room air
- Karnofsky or Lansky performance score of 60 or higher
- Recovered from acute toxic effects of prior chemotherapy at least one week before study entry
- Sexually active patients must agree to use effective birth control during the study and for six months after
- Informed consent explained, understood, and signed by patient or guardian
You will not qualify if you...
- Active infection requiring antibiotics
- Active infection with HIV
- History of other cancers except certain treated skin, breast, or cervix cancers unless disease-free for at least two years
- Currently receiving any investigational agents or tumor vaccines within previous six weeks
- History of hypersensitivity to murine protein products
- Pregnant or lactating
- Tumor located where enlargement could cause airway obstruction
- Clinically significant viral infections or uncontrolled viral reactivation
- Certain cardiac conditions such as atrial fibrillation, recent heart attack, prolonged QT syndrome, low heart function, or significant pericardial effusion
- Presence of central nervous system disease including detectable blast cells in cerebrospinal fluid or uncontrolled neurological disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 3 days
Participants receive 3 daily doses of chemotherapy medications cyclophosphamide and fludarabine to prepare the body for the cell infusion by reducing other T cells.
3 daily visits (in-person) for chemotherapy administration
Treatment
Duration - 1 day infusion plus at least 3 weeks local observation
Participants receive an injection of CD7 chimeric receptor-T cells through an IV following pre-medication with Benadryl and Tylenol. Participants are monitored in the clinic for at least 3 hours after infusion and must remain locally for at least 3 weeks for observation and management of any side effects.
1 infusion visit followed by daily visits or monitoring for 3 weeks
Follow-up
Duration - Up to 15 years
Participants are followed with blood tests and medical assessments to monitor the effects and safety of the therapy, including tumor measurements 4 to 6 weeks after infusion. Long-term follow-up continues for up to 15 years to observe any lasting effects of the gene therapy.
Multiple visits: weekly up to 8 weeks, then at 3, 6, 9, 12 months, every 6 months for 4 years, then yearly
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
L
LaQuisa Hill, MD
M
Martha Arredondo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Feasibility and preclinical efficacy of CD7-unedited CD7 CAR T cells for T cell malignancies.
Norihiro Watanabe, Feiyan Mo, Rong Zheng...
https://pubmed.ncbi.nlm.nih.gov/36086817