Phase I Study of Adoptive Immunotherapy With Enriched and Expanded Autologous Natural Killer (NK) Cells for Patients With Ph+ Acute Lymphoblastic Leukemia (ALL)
Last updated on April 2022Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- WHO score 0-1.
- Hematopoietic, liver and renal normal functions defined as follows:
- Adult subjects with Ph+ ALL in CHR (1st or 2nd) with MRD positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-CHR treatment modalities.
- WHO score 0-1.
- Hematopoietic, liver and renal normal functions defined as follows:
- Adult subjects with Ph+ ALL in CHR (1st or 2nd) with MRD positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-CHR treatment modalities.
Exclusion Criteria
- Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
- Simultaneous participation in another clinical trial.
- Pregnant or lactating females.
- ...
- Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
- Simultaneous participation in another clinical trial.
- Pregnant or lactating females.
- Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
- Any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
- Presence of autoimmune symptoms.
- Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
Summary
- Conditions
- Acute Lymphoblastic Leukemia
- Complete Hematologic Remission (CHR)
- Persistent/Recurrent Minimal Residual Disease (MRD)
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 60 years and 125 years
- Gender
- Both males and females
Description
This is an open label, multicenter, phase I study of adoptive immunotherapy with enriched and expanded autologous natural killer (NK) cells for patients with Ph+ acute lymphoblastic leukemia (ALL) in complete hematologic remission (CHR) but with persistent/recurrent minimal residual disease (MRD) ≥6...
This is an open label, multicenter, phase I study of adoptive immunotherapy with enriched and expanded autologous natural killer (NK) cells for patients with Ph+ acute lymphoblastic leukemia (ALL) in complete hematologic remission (CHR) but with persistent/recurrent minimal residual disease (MRD) ≥60 years or not eligible for other post-CHR treatment modalities. The study will investigate the safety and tolerability of a new type of NK-based immunotherapy based on the infusion of escalating doses of ex-vivo expanded autologous NK cells in Ph+ ALL patients. A maximum of 6 patients will be enrolled in two different steps. No conditioning therapies will be administered before the infusion of the expanded NK cells. Patients may receive tyrosine kinase inhibitor (TKI) maintenance.
Inclusion Criteria
- WHO score 0-1.
- Hematopoietic, liver and renal normal functions defined as follows:
- Adult subjects with Ph+ ALL in CHR (1st or 2nd) with MRD positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-CHR treatment modalities.
- WHO score 0-1.
- Hematopoietic, liver and renal normal functions defined as follows:
- Adult subjects with Ph+ ALL in CHR (1st or 2nd) with MRD positivity confirmed at baseline, older or equal to 60 years or not eligible for other post-CHR treatment modalities.
Exclusion Criteria
- Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
- Simultaneous participation in another clinical trial.
- Pregnant or lactating females.
- ...
- Any physical or psychological impediment in a patient that could lead the investigator to suspect his/her poor compliance to the protocol.
- Simultaneous participation in another clinical trial.
- Pregnant or lactating females.
- Active or chronic infection, including Treponema, HIV, HBV and/or HCV unless antigen/PCR negative.
- Any contraindications to perform a leukapheretic procedure for mononuclear cell collection.
- Presence of autoimmune symptoms.
- Concurrent chemotherapy or immunotherapy (TKI maintenance is permitted).
Locations
- Roma
- Roma
- Roma
- Roma
- Roma
- ...
- Roma
- Roma
- Roma
- Roma
- Roma
Tracking Information
- NCT #
- NCT02185781
- Collaborators
- Not Provided
- Investigators
- Study Chair: Roberto Foà Policlinico Umberto I di Roma Study Director: Giovanni Torelli Policlinico Umberto I di Roma
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