Actively Recruiting
Clinical Trial Using CAR- T Cells 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
303 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
This is a phase l, single arm, prospective open, dose-escalation study in patients with relapsed or refractory CD19-positive B cell malignancies (ALL, NHL, CLL). The trial will include adult and pediatric patients. There will be three individual cohorts, defined by disease biology: pediatric ALL and aggressive pediatric NHL (Cohort 1), adult ALL (Cohort 2) and adult NHL/CLL (Cohort 3).
CONDITIONS
Official 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 with relapsed or refractory ALL, lymphoma, or CLL treated with at least two prior therapies and disease progression or failure to respond
- Philadelphia Chromosome positive ALL patients eligible if disease progressed, stable, or relapsed after two therapies including tyrosine kinase inhibitors
- DLBCL patients with progression, stable disease, or recurrence after initial anthracycline and anti-CD20 antibody treatment
- Patients with transformed FL, MZL, or CLL/SLL progressed or recurrent after DLBCL treatment
- Patients relapsing 12 or more months 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
- Performance status: ECOG ≤ 2 for adults ≥ 16 years; Lansky score ≥ 50% for < 16 years
- Normal organ and marrow function with specified lab and clinical parameters
- At least 2 weeks or 5 half-lives since prior systemic therapy before leukapheresis (exceptions apply)
- Women of reproductive potential must use effective contraception before and during study and for 4 months after CAR-T infusion
- Ability to understand and willing to sign informed consent
You will not qualify if you...
- Autologous transplant within 6 weeks before planned CAR-T infusion
- History of allogeneic stem cell transplant within 4 months before infusion
- Use of immunosuppressive therapy not completed or systemic corticosteroids within 72 hours after infusion
- Presence of graft-versus-host disease grade 2 or higher
- Receiving CAR-T treatment outside this study
- Active central nervous system or meningeal tumor involvement; untreated brain metastases or CNS disease
- History of active malignancy except non-melanoma skin cancer or carcinoma in situ
- HIV or HTLV infection
- Uncontrolled illnesses including infections, heart failure, unstable angina, arrhythmias, lung problems, or psychiatric/social issues
- Pregnant or breastfeeding women
- Evidence of myelodysplasia or related bone marrow abnormalities
- Active hepatitis B or C infection confirmed by positive PCR
- Serious or potentially fatal medical conditions
- History of clinically relevant CNS disorders such as epilepsy, seizures, paresis, aphasia, cerebrovascular disease, severe brain injury, dementia, or Parkinson's
- Autoimmune disease needing immunosuppressive treatment within last 6 months
- Hypersensitivity to any drugs used in the trial or related treatments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Lucila N Kerbauy, MD, PhD
CONTACT
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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