NCT03937544 Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
| NCT ID | NCT03937544 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | National University of Malaysia |
| Condition | Relapsed B Acute Lymphoblastic Leukaemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2019-03-19 |
| Primary Completion | 2027-01-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 10 participants in total. It began in 2019-03-19 with a primary completion date of 2027-01-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT03937544 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 65 Years, studying Relapsed B Acute Lymphoblastic Leukaemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03937544 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT03937544 currently recruiting?
Yes, NCT03937544 is actively recruiting participants. Contact the research team at sfadilah@ppukm.ukm.edu.my for enrollment information.
Where is the NCT03937544 trial being conducted?
This trial is being conducted at Bandar Tun Razak, Malaysia.
Who is sponsoring the NCT03937544 clinical trial?
NCT03937544 is sponsored by National University of Malaysia. The trial plans to enroll 10 participants.