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CAR-T Cell Therapy for ALL

NCT07695012 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-10

No results posted yet for this study

Summary

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.

Conditions

  • Relapsed Acute Lymphoblastic Leukemia (ALL)

Interventions

BIOLOGICAL

CAR-T cell infusion

CAR-T Cell infusion therapy will be given

Sponsors & Collaborators

  • Dr. Zaineb Akram

    lead OTHER_GOV

Principal Investigators

  • Maryam Khan, MBBS, MRCP (UK), FCPS(Cl Haem) · National University of Medical Sciences

  • Tariq Ghafoor · National University of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07695012 on ClinicalTrials.gov