Anti-CD7 Protein Expression Blocker (PEBL) Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia (CARTALL)

Who is this study for? Patients with refractory or relapsed T-lineage acute lymphoblastic leukemia
What treatments are being studied? CAR T-cell therapy
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The objective of this study is to assess the safety and efficacy of anti-CD7 CAR T-cells in patients with refractory or relapsed T-lineage acute lymphoblastic leukemia (T-ALL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 65
Healthy Volunteers: f
View:

• Diagnosis/ Disease define as:

‣ Relapsed T-cell acute lymphoblastic leukaemia/ lymphoma as defined by:

‣ Bone marrow disease = or \> 0.01% by MRD as determined by flow cytometry

‣ Or CNS disease as defined as \> 5 WBCs/ uL in CSF with morphological evidence of blasts or biopsy proven recurrence in the eye or brain

‣ Or Extramedullary relapse as defined by morphological evidence of blasts in the testis or any other extramedullary sites

⁃ Induction failure as defined by:

‣ MRD = or \> 1% by flow cytometry at the end of induction on day 33

‣ Or Failure to achieve morphological remission defined as \> 5% blasts after standard induction chemotherapy

⁃ Refractory disease as defined by:

‣ MRD = or \> 0.01% by flow cytometry or molecular methods during 2 or more timepoints after induction therapy

• Minimum level of pulmonary reserve defined as Grade ≤ 1 dyspnoea and oxygen saturation (SpO2) of \> 95% on room air

• Left ventricular systolic function (LVSF) ≥ 28% confirmed by echocardiogram, or left ventricular ejection fraction (LVEF) ≥ 45% confirmed by echocardiogram within 3 months of screening

• Karnofsky (age ≥ 16 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening

• Normal Age-adjusted eGFR Creatinine Clearance within 3 months of screening

• Alanine aminotransferase ≤ 5 times the upper limit of normal for age

• Patients with \> 99% CD7 expression on blast cells will be eligible for anti-CD7 PEBL-CAR-T cell infusion.

Locations
Other Locations
Singapore
Allen Yeoh Eng Juh
RECRUITING
Singapore
Contact Information
Primary
Allen Yeoh, M.D
paeyej@nus.edu.sg
+65 6772 2002
Time Frame
Start Date: 2021-09-08
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 20
Treatments
Experimental: Single arm
Single arm Phase I Clinical Trial
Sponsors
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov