OncoMatch/Clinical Trials/NCT07695012
CAR-T Cell Therapy for ALL
Is NCT07695012 recruiting? Yes, currently enrolling (Jul 2026). This Early Phase 1 trial studies CAR-T cell infusion for relapsed acute lymphoblastic leukemia (all).
Treatment: CAR-T cell infusion — Acute lymphoblastic leukemia (ALL) is the most common malignancy in children and the second most frequent acute leukemia in adults. B-cell ALL constitutes approximately 85% of all ALL diagnoses. In Pakistan, ALL represents the most prevalent haematological malignancy presenting to tertiary centres, with AFBMTC receiving the largest national referral volume for haematological malignancies and transplantation. First-line combination chemotherapy achieves complete remission (CR) in \>95% of paediatric patients; however, 15-20% relapse. Outcomes following first relapse are substantially inferior: second-line salvage chemotherapy achieves CR2 in 30-50% of patients, and long-term event-free survival (EFS) after conventional chemotherapy alone is \<10%. Outcomes in adult ALL are even more dismal, with OS at 5 years below 40% even in first CR without allogeneic transplant. Patients with primary refractory ALL or multiply relapsed ALL have an unmet medical need for novel therapeutic approaches. The classical paradigm of chemotherapy followed by allogeneic haematopoietic stem cell transplantation (allo-HSCT) is limited by donor availability, conditioning-related mortality, and inability to achieve remission before transplant.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Lymphoblastic Leukemia
Biomarker criteria
Required: CD19 expression (≥20% CD19-positive blasts)
CD19 expression on tumour cells confirmed by multi-parameter flow cytometry within 3 months of enrolment (≥20% CD19-positive blasts required)
Excluded: CD19 antigen-loss
confirmed CD19-negative (antigen-loss) relapse on anti-CD19-based therapy
Demographics
Prior therapy
Cannot have received: CAR-T cell therapy
Prior treatment with any CAR-T or adoptive T-cell product
Cannot have received: gene therapy with viral vector (non-CAR gene therapy)
Prior gene therapy with a viral vector (non-CAR gene therapy); or prior receipt of a gene-edited cellular product
Lab requirements
Blood counts
ALC ≥100/µL and CD3+ count ≥100/µL at time of apheresis, or acceptable stored product available
Kidney function
Age-adjusted serum creatinine within normal limits per CTCAE paediatric reference tables, or GFR ≥30 mL/min/1.73m² (MDRD/CKD-EPI)
Liver function
ALT/AST ≤5× ULN; Total bilirubin <2.0 mg/dL
Cardiac function
LVEF ≥45% or LVSF ≥28% on echocardiogram (performed within 28 days of screening)
Adequate organ function at screening: Renal, Hepatic, Cardiac, Pulmonary
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07695012 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, gene therapy with viral vector (non-CAR gene therapy) disqualifies patients from enrollment.
Does this trial require CD19?
Yes, CD19 expression is a required biomarker for enrollment.
Are patients with CD19 alterations eligible?
No. CD19 antigen-loss is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 50 years or younger and at least 5 years old.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages