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CD19 Targeted CAR T Cell Therapy in Patients With Relapsed/ Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)

NCT04653493 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2021-03-19

No results posted yet for this study

Summary

This is a single-arm, open-label, phase I study (safety and dose escalation) of autologous Chimeric Antigen Receptor (CAR) T-cells targeting CD19 in patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL).

Conditions

  • Relapsed B Cell Acute Lymphoblastic Leukemia (ALL)
  • Refractory B Cell Acute Lymphoblastic Leukemia (ALL)

Interventions

BIOLOGICAL

CD19 CAR engineered autologous T-cells

Given IV Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities.

DRUG

Cyclophosphamide

Given IV

DRUG

Fludarabine

Given IV

DRUG

Mesna

Given IV

Sponsors & Collaborators

  • Gene Therapy Research Center, Shariati Hospital, Tehran University of Medical Sciences, Iran

    collaborator UNKNOWN

  • Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences, Iran

    collaborator UNKNOWN

  • Sabz Biomedicals

    lead INDUSTRY

Principal Investigators

  • Tahereh Rostami, M.D · Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences, Tehran, Iran

  • Naser Ahmadbeigi, PhD · Gene Therapy Research Center, Shariati hospital, Tehran University of Medical Sciences, Tehran, Iran

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-31
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

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 NCT04653493 on ClinicalTrials.gov