CARTALL: Chimeric-Antigen Receptor (CAR) T-Cell Therapy for Relapsed/ Refractory T-Lineage Acute Lymphoblastic Leukaemia

NCT05043571 | Recruiting Phase 1 DMC

• 1 other identifier: 2020/01325
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lymphoblastic Leukemia, Acute, Childhood; Lymphoblastic Leukemia; Lymphoblastic Leukemia, Acute Adult; Lymphoblastic Leukemia in Children; CAR; CAR T-Cell-Related Encephalopathy Syndrome; Refractory Leukemia

Keywords

T-ALL; CAR-T cell therapy; CAR T-cell therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of participant who are flow cytometry minimal residual disease (MRD) negativity at 1 month after Anti-CD7 PEBL CAR T-cell infusion.

  MRD levels will be determined by flow cytometry. The target sensitivity of flow MRD is \<0.01% when available.

  30 days

Secondary Outcomes (2)

• Proportion of participant who are minimal residual disease (MRD) negative with molecular base assay at the end of 1 month after Anti-CD7 PEBL CAR T-cell infusion.

  30 days

• Proportion of patient who shows CAR T-cell persistence by immunophenotyping using flow cytometry in bone marrow, peripheral blood and CSF samples at multiple study time points following CAR T cell infusion

  1 month to 5 years

Study Arms (1)

Single arm

EXPERIMENTAL

Single arm Phase I Clinical Trial

Biological: CAR T-cell therapy

Interventions

CAR T-cell therapy BIOLOGICAL

This is a single-centre, phase I study to determine the efficacy and safety of CAR T-cell therapy in patients with high-risk T-ALL, refractory or relapsed T-ALL.

Single arm

Eligibility Criteria

• Age: 6 Months - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who test positive on urine pregnancy testing and are pregnant or are lactating
• Concomitant genetic syndromes associated with bone marrow failure states, such as Fanconi anaemia, Kostmann syndrome, Schwachman syndrome, or any other bone marrow failure syndrome with the exception of Down syndrome
• Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and no evidence of active disease
• Active or latent hepatitis B or hepatitis C infections within 8 weeks of screening, or any uncontrolled infection at screening
• Positive Human Immunodeficiency Virus (HIV) test within 8 weeks of screening
• Grade 2 to 4 acute graft-vs-host disease (GVHD) or extensive chronic GVHD
• Received an investigational medicinal product within 30 days of screening
• Central nervous system : Uncontrolled seizures or status epilepticus; increased intra-cranial pressure as evidenced by papilledema and CSF opening pressure \> 20 cm water; decreased conscious state (any cause)

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

Allen Yeoh Eng Juh

Singapore, 119228, Singapore

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Allen Yeoh, M.D

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

• Dario Campana, M.D, PhD

  National University of Singapore

  STUDY DIRECTOR

Central Study Contacts

Allen Yeoh, M.D

CONTACT

+65 6772 2002; paeyej@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2021
• First Posted: September 14, 2021
• Study Start: September 8, 2021
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 14, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)