Using patients' own modified immune cells to treat relapsed B-ALL

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

This study is testing if using patients' own modified immune cells can help people with relapsed B-ALL feel better and improve their chances of recovery.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 13 Years to 65 Years
• Sex: All
• Sponsor: National University of Malaysia (Academic / other)
• Drugs / interventions: Chemotherapy, immunotherapy, CAR-T
• Locations: 1 site (Bandar Tun Razak, Kuala Lumpur)
• Trial ID: NCT03937544 on ClinicalTrials.gov

What this trial studies

This Phase II/III clinical trial evaluates the safety and efficacy of intravenous autologous CD19 CAR-T cells in patients with relapsed or refractory B-Acute Lymphoblastic Leukaemia (B-ALL). The study involves a single-arm, open-label design where patients receive their own modified T cells, which are engineered to target and eliminate cancer cells. Participants will also receive chemotherapy agents, Cyclophosphamide and Fludarabine, to prepare their immune systems for the CAR-T cell infusion. The trial aims to assess how well this treatment can improve outcomes for patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are patients aged 13 to 65 with relapsed or refractory B-ALL and adequate organ function.

Not a fit: Patients with advanced CNS leukaemia or those with active graft-versus-host disease (GVHD) may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective option for patients with difficult-to-treat B-ALL.

How similar studies have performed: Other studies using CAR-T cell therapy for B-ALL have shown promising results, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Where this trial is running

Bandar Tun Razak, Kuala Lumpur

• UKM Medical Centre — Bandar Tun Razak, Kuala Lumpur, Malaysia (Recruiting)

Study contacts

• Study coordinator: S Fadilah Abdul Wahid, MD, DrIntMed, PhD

Conditions Relapsed B Acute Lymphoblastic Leukaemia; Refractory B Acute Lymphoblastic Leukaemia