Actively Recruiting
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Led by KK Women's and Children's Hospital · Updated on 2023-03-09
40
Participants Needed
2
Research Sites
246 weeks
Total Duration
On this page
Sponsors
K
KK Women's and Children's Hospital
Lead Sponsor
S
Singapore General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to describe feasibility of delivering point-of-care manufactured CD19-directed CAR T-cell therapy to patients with relapsed/ refractory B-lineage leukaemia/ lymphoma.
CONDITIONS
Official Title
CD19-Directed Chimeric Antigen Receptor (CAR) T-Cell Therapy for Relapsed/Refractory B-Lineage Leukaemia / Lymphoma - A Feasibility Protocol
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) with lymphoblasts in bone marrow or positive minimal residual disease at screening
- Relapsed/refractory or ineligible for hematopoietic stem cell transplant (HSCT)
- For relapsed B-ALL, documented CD19 tumor expression within 3 months of study entry
- Diagnosis of relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
- Age under 18 years (pediatric group) or 18 years and older (adult group)
- Adequate organ function
- Life expectancy greater than 12 weeks
- Karnofsky (age ≥16 years) or Lansky (age <16 years) performance status of 50 or higher
- Meet institutional criteria for leukapheresis or have an accepted leukapheresis product
You will not qualify if you...
- B-ALL with isolated extramedullary disease relapse
- Concomitant genetic syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome, or other bone marrow failure syndromes (Down syndrome allowed)
- Diagnosis of Burkitt's lymphoma/leukemia or mature B-cell ALL with specific markers
- Active or latent hepatitis B or active hepatitis C within 8 weeks of screening
- HIV positive within 8 weeks of screening
- Grade 2 to 4 acute or extensive chronic graft-versus-host disease (GVHD)
- Active central nervous system (CNS) involvement by malignancy (CNS-3 per NCCN guidelines)
- Use of investigational medicinal product within 30 days prior to screening
- Pregnant or nursing women
- Women of childbearing potential and all male participants not using highly effective contraception for 1 year after CAR T-cell infusion or who do not have a negative pregnancy test within 48 hours before infusion
- Prior malignancy except certain treated carcinomas
- Prior gene therapy or certain anti-CD19 therapies, to be discussed with study investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Singapore General Hospital
Singapore, Singapore, 169608
Actively Recruiting
2
KK Women's and Children's Hospital
Singapore, Singapore, 229899
Actively Recruiting
Research Team
S
Shui Yen Soh, MD
CONTACT
G
Germaine Liew, BS
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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