CTRI/2022/03/041162
Active, Not Recruiting
Phase 2
A phase 2 study to determine the safety and efficacy of IMN-003A cell therapy in patients with relapsed and refractory CD19 positive B cell malignancies - IMAGINE
Immuneel Therapeutics Private Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C859- Non-Hodgkin lymphoma, unspecified
- Sponsor
- Immuneel Therapeutics Private Limited
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Relapsed / Refractory B\-Acute Lymphoblastic Leukaemia
- •1\.Age 3 years to 45 years at the time of screening
- •2\.Beyond first relapse
- •3\.Any relapse 6 months after hematopoietic stem cell transplant (HSCT)
- •4\.Primary refractory disease
- •5\.Philadelphia positive ALL intolerant of TKI
- •6\.Ineligible for allogeneic HSCT
- •7\.Declines allogeneic HSCT
- •Relapsed / Refractory B\-cell Non\-Hodgkin’s Lymphoma
- •1\.Age 18 years or older
Exclusion Criteria
- •Relapsed / Refractory B\-Acute Lymphoblastic Leukemia
- •1\.Presence of Grade 2 to 4 acute or extensive chronic graft\-versus\-host disease (GVHD) or ongoing immunosuppressants
- •Relapsed / Refractory B\-cell Non\-Hodgkin’s Lymphoma
- •1\.History of Richter’s transformation of CLL
- •2\.History of allogeneic stem cell transplantation
- •Applicable to all patients
- •1\.Previous treatment with CD19 targeted monoclonal antibody or gene therapy
- •2\.Clinically significant active infection
- •3\.Current CNS disease or other CNS pathology
Outcomes
Primary Outcomes
Not specified
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