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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: S Fadilah Abdul Wahid, MD, DrIntMed, PhD
• Email: sfadilah@ppukm.ukm.edu.my
• Phone: +60391456450

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Glofitamab plus obinutuzumab for mantle cell lymphoma after CAR‑T

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• CD7 CAR T-Cell Therapy for T-Cell Lymphomas

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• Using golcadomide and rituximab to prepare patients for CAR T-cell therapy in aggressive B-cell lymphoma

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  Recruiting at 7 sites Phase 2 Mayo Clinic · Scottsdale, Arizona and 6 other locations · NCT06834373

• Loncastuximab tesirine plus rituximab as bridging therapy before CAR-T for relapsed or refractory large B‑cell lymphoma

  This trial tries loncastuximab tesirine with rituximab as a bridge before commercial CD19 CAR‑T therapy for adults with relapsed or refractory large B‑cell lymphoma to see if it is safe and helps control disease before CAR‑T.

  Recruiting at 2 sites Phase 2 University of Utah · Chapel Hill, North Carolina and 1 other locations · NCT06788964

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.