Phase I/II Study of Adaptive Manufactured Lentiviral Anti-CD20/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma.
Nirav N Shah, Alfredo S Colina, Bryon D Johnson...
https://pubmed.ncbi.nlm.nih.gov/40163793Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 80Years
All Genders
ID04186520
Phase I/II Study of Tandem, Bispecific Anti-CD19 Anti-CD20 CAR-T Cells for Patients With Relapsed and/or Refractory B Cell Malignancies
Led by Medical College of Wisconsin · Updated on 2026-02-23
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of CAR-20/19-T cells expanded with Interleukin-7 and Interleukin-15 (IL-7/IL-15) in adults with relapsed or refractory B cell malignancies, including various types of non-Hodgkin lymphoma, chronic lymphocytic leukemia (CLL), and central nervous system (CNS) lymphoma. This Phase 1/2 study also examines how flexible manufacturing of these CAR-T cells affects treatment feasibility and outcomes. The trial includes several groups to test different manufacturing processes and patient populations. Participants receive a fixed dose of 2.5 million CAR-20/19-T cells per kilogram of body weight, expanded with IL-7/IL-15. The study has multiple arms, including flexible manufacturing with 8- or 12-day production times, a fixed 12-day manufacturing process, and a group with cryopreserved CAR-T cells before infusion. Separate groups also focus on CLL and CNS lymphoma patients. The Phase 2 portion measures the complete response rate at three months in mantle cell lymphoma (MCL) patients. During the study, patients undergo detailed assessments including brain MRI and lumbar puncture when needed, disease measurement through scans or biopsies, and blood tests to monitor safety and treatment effects. Researchers track adverse events within the first 28 days after infusion as a primary outcome. Participants are monitored for safety, treatment response, and long-term follow-up. The total study duration and specific procedures depend on the study arm and patient condition.
CONDITIONS
Brief Title
CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies
Who Can Participate
Age: 18Years - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years with relapsed or refractory B-cell non-Hodgkin lymphoma
- Absolute CD3 count of at least 50 cells/mm3
- Measurable disease documented within 4 weeks before consent
- Karnofsky performance score of 70 or higher
- Adequate liver, kidney, cardiac, and pulmonary function
- ANC of at least 1000 without recent growth factor use
- Platelet count of at least 50,000 without recent transfusion
- Able to provide informed consent
- Agree to use birth control during the study
- Expected survival greater than 12 weeks
- Negative pregnancy test for females of childbearing potential
- No contraindication to central line access
- Demonstrated compliance to prior therapies
- Specific disease and treatment history criteria depending on study arm
You will not qualify if you...
- Positive pregnancy test in females of childbearing potential
- Active HIV, Hepatitis B, or Hepatitis C infection
- Significant or uncontrolled autoimmune disease requiring high-dose steroids
- Grade 3 or higher non-hematologic toxicities from prior treatments
- Concurrent use of other investigational therapies or clinical trials
- Refusal to participate in long-term follow-up
- Active CNS involvement by malignancy (except in specific study arm)
- Recent allogeneic stem cell transplant with ongoing complications
- Prior allogeneic CAR-T therapy
- Recent autologous CAR-T therapy or high residual CAR-T cells
- Recent anti-CD20 or anti-CD19 antibody treatment
- Recent cytotoxic chemotherapy or steroid treatment before cell collection
- Recent oral chemotherapy or antibody treatments
- Patients post solid organ transplant with high-grade lymphomas or leukemias
- Concurrent active malignancy other than certain skin cancers
- Failure to meet fertility and contraception requirements
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 - 8 to 12 days or fixed 12 days depending on manufacturing process
Participants undergo cell collection and manufacturing of CAR-20/19-T cells with either 8/12-day flexible or fixed 12-day processes, including cryopreservation for some cohorts.
1 visit for apheresis and manufacturing process
Treatment
Duration - Single infusion visit followed by monitoring for 28 days post infusion
Participants receive a fixed dose of 2.5 x 10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15 to treat relapsed or refractory B-cell malignancies.
1 infusion visit plus weekly visits for up to 4 weeks
Follow-up
Duration - Up to 3 months or longer as determined by study
Participants are monitored for safety and efficacy outcomes after CAR-T cell infusion including assessment of adverse events.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 1 location
1
Medical College of Wisconsin and Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Loading map...
Research Team
M
Medical College of Wisconsin Cancer Center Clinical Trials Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Bispecific targeting of CD20 and CD19 increases polyfunctionality of chimeric antigen receptor T-cell products in B-cell malignancies.
Joanna C Zurko, Huiqing Xu, Katherine Chaney...
https://pubmed.ncbi.nlm.nih.gov/35597752