Third-generation anti-CD19 CAR T cells for relapsed/refractory chronic lymphocytic leukemia: a phase 1/2 study.
Patrick Derigs, Maria-Luisa Schubert, Peter Dreger...
https://pubmed.ncbi.nlm.nih.gov/39192036Actively Recruiting
Phase 1
Phase 2
Age: 3Years +
All Genders
ID03676504
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Lymphocytes Transduced by RV-SFG.CD19.CD28.4-1BBzeta Retroviral Vector - a Unicenter Phase I/II Clinical Trial
Led by University Hospital Heidelberg · Updated on 2024-07-29
68
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a new treatment using specially modified T cells called CD19.CAR T cells in patients with relapsed or refractory CD19-positive lymphoid diseases. This includes adults with acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and pediatric patients with ALL. The study is a Phase I/II clinical trial led by the University Hospital Heidelberg. Participants receive escalating doses of CD19.CAR T cells after a preparatory treatment called lymphodepletion using fludarabine and cyclophosphamide. The doses range from 1x10^6 to 20x10^7 transduced cells per square meter of body surface area. The study includes three groups: adults with relapsed or refractory ALL, adults with relapsed or refractory CLL or lymphomas, and children with relapsed or refractory ALL. During the trial, researchers monitor participants closely for safety by assessing side effects such as cytokine release syndrome and neurotoxicity for up to 90 days after treatment. They also evaluate the feasibility of producing the modified T cells before administration. Participants undergo various clinical assessments, including performance status, organ function tests, and disease measurements. The study aims to gather important information on the treatment's safety and manufacturing process over time, with the trial expected to continue until the end of 2027.
CONDITIONS
Brief Title
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
Who Can Participate
Age: 3Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults (18 years and older) with confirmed CD19+ ALL, CLL, DLBCL, FL, or MCL
- Pediatric patients aged over 3 years and under 18 years with confirmed CD19+ ALL
- Relapsed or refractory disease with measurable disease or minimal residual disease (MRD) at enrollment
- Life expectancy of at least 12 weeks
- ECOG performance status of 2 or less (for patients aged 16 and older) or Lansky performance status of at least 50 (for patients under 16)
- Adequate organ function including kidney, liver, lung, heart, and blood counts as specified
- Women of child-bearing potential and male participants must agree to use effective contraception for one year after treatment
- Ability to understand the trial and provide written informed consent
You will not qualify if you...
- Use of immunosuppressive medication other than low-dose prednisolone at time of treatment
- Ongoing bridging or maintenance therapy within 2 weeks before leukapheresis
- Active or recent graft-versus-host disease (GvHD)
- Uncontrolled active hepatitis B or C infection
- HIV positivity
- Uncontrolled life-threatening infections
- Severe other diseases such as uncontrolled hypertension, heart failure, or diabetes
- Recent unstable angina or heart attack within 3 months
- Previous or concurrent malignancies except adequately treated non-melanoma skin cancer or certain in situ carcinomas
- Pregnancy or nursing
- Intolerance to components of the cell product
- Active central nervous system involvement at treatment time with CNS 3 status
- Participation in another clinical trial at screening
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)
Treatment
Duration - Approximately 1 week
Participants receive chemotherapy with fludarabine and cyclophosphamide for 3 days followed by infusion of CD19.CAR T cells at varying dose levels.
Daily visits for 3 days for chemotherapy and 1 visit for CAR T cell infusion
Follow-up
Duration - Up to 90 days after CAR T cell administration
Participants are monitored for safety and treatment effects, including assessment for toxicities such as cytokine release syndrome and neurotoxicity.
Regular visits during the 90-day period
Trial Site Locations
Total: 2 locations
1
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
2
University Hospital Heidelberg
Heidelberg, Germany
Actively Recruiting
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Research Team
P
Prof. Dr. Michael Schmitt
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Treatment of adult ALL patients with third-generation CD19-directed CAR T cells: results of a pivotal trial.
Maria-Luisa Schubert, Anita Schmitt, Angela Hückelhoven-Krauss...
https://pubmed.ncbi.nlm.nih.gov/37481608Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector: a unicentre phase I/II clinical trial protocol.
Maria-Luisa Schubert, Anita Schmitt, Leopold Sellner...
https://pubmed.ncbi.nlm.nih.gov/31110096