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

NCT03937544 | Recruiting Phase 2 DMC

• 2 other identifiers: JEP-2019-003FF-2019-138
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed B Acute Lymphoblastic Leukaemia; Refractory B Acute Lymphoblastic Leukaemia

Outcome Measures

Primary Outcomes (3)

• Overall response rate (ORR)

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

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

• 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.

  12 Months

• 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.

  12 Months

Secondary Outcomes (4)

• Overall survival (OS)

  12 Months, 24 Months

• Progression free survival (PFS)

  12 Months, 24 Months

• Time to next treatment (TTNT)

  12 Months, 24 Months

• Percentage of adverse events

  30 days

Study Arms (1)

CD19 CAR-T CELLS

EXPERIMENTAL

A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.

Biological: CD19 CAR-T CELLS; Drug: Cyclophosphamide; Drug: Fludarabine

Interventions

CD19 CAR-T CELLS BIOLOGICAL

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

CD19 CAR-T CELLS

Cyclophosphamide DRUG

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

CD19 CAR-T CELLS

Fludarabine DRUG

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

CD19 CAR-T CELLS

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Adequate organ function as defined by a creatinine clearance \> 50 ml/min, serum total bilirubin \< 5 times the normal value, left ventricular ejection fraction \> 40%
• ECOG performance status ≤ 2
• Life expectancy \> 3 months
• Post allogeneic HSCT must be ≥ Day +100 with no evidence of active GVHD and not receiving immunosuppression
• Female patients of child bearing age must have negative pregnancy test and is on highly effective contraception methods
• Male patients must use highly effective contraception methods

You may not qualify if:

• 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.
• HIV serology positivity.
• Active Hepatitis B or C infection as evidenced by quantitative viral PCR assay.
• Uncontrolled sepsis
• Pregnant / nursing female.
• Ongoing prednisolone \> 1mg/kg daily or equivalent.
• Chemotherapy immunotherapy in the recent 4 weeks such as allogeneic cellular therapy weeks, anti-GVHD therapy.

Sponsors & Collaborators

• National University of Malaysia: lead
• Gaia Science: collaborator

Study Sites (1)

UKM Medical Centre

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Precursor B-Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Cyclophosphamide; fludarabine

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

S Fadilah Abdul Wahid, MD, DrIntMed, PhD

CONTACT

+60391456450; sfadilah@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Pusat Terapi Sel / Principal Investigator

Study Record Dates

• First Submitted: April 22, 2019
• First Posted: May 3, 2019
• Study Start: March 19, 2019
• Primary Completion (Estimated): January 18, 2027
• Study Completion (Estimated): March 18, 2027
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

MY (1)