Health TrialsbyHealthPanel

Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

ConditionsRelapsed B Acute Lymphoblastic LeukaemiaRefractory B Acute Lymphoblastic Leukaemia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age13-65
SponsorNational University of Malaysia

About this trial

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with relapsed/refractory B-ALL in accordance with World Health Organization (WHO) classification by virtue of BM morphology, flow cytometry, cytogenetics and molecular genetics

Age between ≥13 to ≤ 65 years

No detectable leukaemia in the CSF (CNS-1)

CNS leukaemia without clinically evident neurological symptoms (CNS-2; with <5 WBC per μL and cytology positive for blasts)

Disqualifiers

Patients with CNS-3 leukaemia.

Active cancer (other than B-ALL).

Evidence of severe lung, heart (NYHA class III/IV, arrhythmia, AV block, uncontrolled hypertension), liver, or renal failure or severe neurologic disorder.

Presence of active autoimmune disease or atopic allergy.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19 CAR-T CELLS

    Biological/Vaccine

    CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.

  • Cyclophosphamide

    Drug

    Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).

  • Fludarabine

    Drug

    Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: CD19 CAR-T CELLSExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall response rate (ORR)

Overall Response Rate (ORR) defined as Complete Response (CR) and CR with incomplete blood recovery (CRi) according to WHO criteria.

Time frame
Participants will be followed for the duration of the treatment, with an expected average of 3 months.
2

Complete response (CR)

Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.

Time frame
12 Months
3

CR with incomplete blood recovery (CRi).

Duration of response defined from the time when criteria for response (CR or CRi) are met to the first documentation of relapse or progression.

Time frame
12 Months

Secondary outcomes

1

Overall survival (OS)

Overall Survival (OS) defined as the time from treatment to the date of death due to any cause.

Time frame
12 Months, 24 Months
2

Progression free survival (PFS)

Progression Free Survival (PFS) defined as the time from treatment to first documentation of objective leukemic progression (date of leukaemia assessment documenting progressive disease) or to death due to any cause. Progression is assessed by BM biopsy or CSF analysis according to NCCN criteria. It is assessed at Day 30 and monthly thereafter, or earlier if clinically indicated.

Time frame
12 Months, 24 Months
3

Time to next treatment (TTNT)

Time To Next Treatment (TTNT) defined as the end of study treatment until the institution of the next therapy.

Time frame
12 Months, 24 Months
4

Percentage of adverse events

Percentage of participants with adverse events

Time frame
30 days

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

UKM Medical CentreRecruiting56000, Bandar Tun Razak, Kuala LumpurMalaysiaMalaysia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National University of Malaysia

Lead sponsor

Gaia Science

Collaborator

Source ClinicalTrials.gov
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