Actively Recruiting
A Phase I Clinical Trial Using Genetically Engineered Autologous T Cells to Express Chimeric Antigen Receptor (CAR) for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies
Led by Nelson Hamerschlak · Updated on 2025-09-25
30
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
Sponsors
N
Nelson Hamerschlak
Lead Sponsor
M
Miltenyi Biotec, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and appropriate dosing of a new treatment using genetically engineered T cells called CAR-T cells for patients with relapsed or refractory CD19-positive B cell cancers, including acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL). This phase 1, open-label trial includes both adult and pediatric patients divided into three groups based on their disease type: pediatric ALL and aggressive pediatric NHL, adult ALL, and adult NHL/CLL. The aim is to find the recommended dose for future studies while monitoring safety closely. Participants will receive a lymphodepleting chemotherapy regimen with Cyclophosphamide and Fludarabine before getting an infusion of CAR-T cells on day 0. The study uses a dose-escalation design where different dose levels of CAR-T cells are tested in small groups to identify the highest safe dose. If side effects called dose-limiting toxicities occur, dosing adjustments and expansions of patient groups are made to ensure safety. Several dose levels are planned, starting with lower doses and increasing if tolerated. During the study, patients will be monitored closely for adverse effects and treatment response through blood tests, imaging, and clinical exams. Researchers will assess the recommended CAR-T cell dose up to 28 days after infusion and evaluate treatment outcomes at multiple time points up to several years. Long-term follow-up includes monitoring overall survival, disease progression, and the persistence of CAR-T cells in the body. Participation may last several years to fully capture these outcomes and ensure patient safety.
CONDITIONS
Brief Title
Clinical Trial Using CAR- T Cells for Treatment of Patients With Refractory or Relapsed CD19-positive B Lymphoid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have relapsed or refractory acute lymphoblastic leukemia, lymphoma, or chronic lymphocytic leukemia treated with at least two prior therapies and with disease progression or lack of remission.
- Philadelphia Chromosome positive ALL patients are eligible if progressed or relapsed after two lines of therapy including tyrosine kinase inhibitors.
- DLBCL patients must have progressed, had stable disease, or recurred after initial treatments including anthracycline and anti-CD20 antibody.
- Patients with transformed FL, MZL, or CLL/SLL must have progressed, had stable disease, or recurred with transformed disease after initial DLBCL treatment.
- Patients relapsing 12 months or more after therapy must have progressed after autologous transplant or be ineligible for transplant.
- Disease must be CD19 positive by immunohistochemistry or flow cytometry.
- Age between 2 and 70 years.
- Adults must have ECOG performance status of 2 or less; children under 16 must have Lansky score of 50% or higher.
- Normal organ and marrow function with specific lab value limits and oxygen levels.
- At least 2 weeks or 5 half-lives since prior systemic therapy before leukapheresis, with exceptions for immune checkpoint therapy and Blinatumomab.
- Women of reproductive potential must use effective contraception before and during study and for 4 months after CAR-T therapy.
- Ability and willingness to sign informed consent.
You will not qualify if you...
- Autologous transplant within 6 weeks before planned CAR-T infusion.
- Allogeneic stem cell transplant within 4 months before CAR-T infusion.
- Current use of immunosuppressive therapy, with specified washout periods.
- Graft-versus-host disease of grade 2 or higher.
- Receiving CAR-T treatment outside this trial.
- Active central nervous system or meningeal tumor involvement or untreated brain metastases.
- Active malignancy other than certain skin cancers or carcinoma in situ.
- HIV or HTLV infection.
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmia, lung disease, or psychiatric conditions limiting compliance.
- Pregnant or breastfeeding women.
- Evidence of myelodysplasia.
- Active hepatitis B or C infection.
- Serious or potentially fatal medical conditions.
- History of significant CNS disorders such as epilepsy, seizure disorders, cerebrovascular disease, severe brain injury, dementia, or Parkinson's disease.
- Autoimmune diseases requiring immunosuppressive medication within 6 months.
- Hypersensitivity to drugs used in the trial or related therapies.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive lymphodepleting chemotherapy with Cyclophosphamide and Fludarabine prior to CAR-T cell infusion.
Daily visits for 4 days
Duration - Until day 28 after CAR-T cells infusion
Participants receive a single infusion of CAR-T cells at one of the specified dose levels followed by monitoring for dose-limiting toxicities and response.
1 infusion visit and multiple follow-up visits up to day 28
Duration - Up to 5 years after infusion
Participants are monitored for long-term response, survival, and CAR-T cell persistence.
Multiple visits at days 2, 7, 10, 14, 28, weeks 8, 12, and months 6, 12, 24, 36, 48, 60
Trial Site Locations
Total: 1 location
1
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05652-900
Actively Recruiting
Research Team
N
Nelson Hamerschlak, MD, PhH
L
Lucila N Kerbauy, MD, PhD
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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