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Cell Therapy with Anti-CD19 CAR-NK Cells in Patients with Relapsed or Resistant B-ALL

ConditionAcute Lymphocytic Leukemia in Relapse
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age3+
SponsorShahid Beheshti University of Medical Sciences

About this trial

Immunotherapy has shown promise in treating hematological malignancies, including resistant B-ALL. One approach is CAR-NK cell therapy, which involves genetically modifying natural killer (NK) cells to target specific cancer antigens. While CAR-NK therapy offers advantages over CAR-T therapy, such as reduced immune system reactions and lower production time and cost, challenges remain regarding antitumor efficacy and the tumor microenvironment. Preclinical and early clinical studies have targeted various antigens, including CD19, with CAR-NK cells in resistant B-ALL. To further investigate the potential of anti-CD19 CAR-NK cell therapy, this study aims to evaluate its safety and determine the maximum tolerated dose (MTD) in patients who have not responded to standard treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • anti CD19 CAR NK cells

    Biological/Vaccine

    Ten eligible patients with relapsed Acute Lymphoblastic Leukemia will be enrolled based on inclusion criteria and informed consent. After conditioning with Fludarabine and Cyclophosphamide, patients will receive a single infusion of anti-CD19 CAR NK cells with close monitoring using one of the following dose levels: • Dose Level 1: 1×10\^7/Kg • Dose Level 2: 5×10\^7/Kg • Dose Level 3: 1×10\^8/Kg Safety Assessment: Adverse events will be recorded and graded. Laboratory parameters and cytokine release syndrome (CRS) markers will be closely monitored. Efficacy Evaluation: Response assessments will follow International Lymphoma Party (LWP) Group guidelines, including complete response (CR), partial response (PR), stable disease (SD), and progressive disease.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Acute lymphocytic leukemia, in relapseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of dose-limiting toxicity (DLTs)

Incidence of dose-limiting toxicity (DLTs) within 4 weeks after infusion, characterized by \>= Grade 3 signs/symptoms according to CTCAE v4.03, to assess safety and tolerability.

Time frame
4 weeks
2

Assessment of Maximum Tolerated Dose (MTD)

Time frame
4 weeks
3

Overall Remission Rate (ORR)

Overall Remission Rate (ORR) two months after infusion, assessed using International lymphoma party (LWP) Group

Time frame
8 weeks

Secondary outcomes

1

Progression-free survival (PFS)

Assessed using International Lymphoma Working Party (LWP) criteria

Time frame
48 weeks
2

Duration of Response (DOR)

Duration of Response (DOR) for up to 12 months, Assessed using International Lymphoma Working Party (LWP) criteria

Time frame
48 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shahid Beheshti University of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: