Actively Recruiting
CARPALL: Immunotherapy with CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia
Led by University College, London · Updated on 2025-04-02
50
Participants Needed
3
Research Sites
1343 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety, efficacy and duration of response of CD19+CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in children with high risk, relapsed CD19+ and CD22+ acute lymphoblastic leukaemia
CONDITIONS
Official Title
CARPALL: Immunotherapy with CD19+CD22 CAR T-cells for CD19+ and CD22+ Acute Lymphoblastic Leukaemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children and young adults age 24 years or younger with high risk or relapsed CD19+ and CD22+ acute lymphoblastic leukemia
- Resistant disease with more than 5% blasts after induction therapy
- Persisting high level minimal residual disease at second time point of frontline protocol
- High risk infant ALL under 6 months old with specific genetic features and poor steroid response
- Patients with t(17;19) TCF3-HLF rearrangement
- High risk first relapse including very early and early relapses and those with high risk genetics
- On therapy relapse in patients aged 16-24
- Any relapse of infant ALL
- Relapse after second or subsequent relapse
- Refractory relapse with more than 1% blasts after chemotherapy
- MRD over 10-4 before planned stem cell transplant
- Relapse eligible for transplant but no suitable donor or contraindications
- Relapse after stem cell transplant at least 4 months post-transplant
- Early loss of B cell aplasia or CD19+CD22+ relapse after prior CD19CAR T-cell therapy
- Patients with isolated CNS relapse meeting above criteria
- Agreement to pregnancy testing and contraception if applicable
- Written informed consent
You will not qualify if you...
- Active Hepatitis B, C, or HIV infection
- Oxygen saturation less than or equal to 90% on air
- Bilirubin more than 3 times upper limit of normal
- Creatinine more than 3 times upper limit of normal
- Pregnant or breastfeeding women
- Stem cell transplant patients with active significant acute or chronic graft versus host disease requiring steroids
- Inability to tolerate leukapheresis
- Karnofsky score or Lansky score 50% or less
- Significant neurological disorder other than CNS involvement of leukemia
- CD19 negative or CD22 negative disease
- Severe infection at time of scheduled CAR T-cell infusion
- Need for supplementary oxygen or active lung infiltrates at infusion time
- Active significant graft versus host disease requiring steroids at infusion time
- Presence of cytokine release syndrome grade above 2 or neurotoxicity grade above 2 after first CAR T-cell infusion before second dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Great Ormond Street Hospital
London, United Kingdom
Actively Recruiting
2
University College Hospital
London, United Kingdom
Actively Recruiting
3
Manchester Royal Children's Hospital
Manchester, United Kingdom
Actively Recruiting
Research Team
A
Aniqa Tasnim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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