A study to test a new type of treatment for blood cancer. In this new treatment the blood cells ofpatients are modified to kill cancer cell on their own.
- Conditions
- Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]Health Condition 2: C859- Non-Hodgkin lymphoma, unspecified
- Registration Number
- CTRI/2022/03/041162
- Lead Sponsor
- Immuneel Therapeutics Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
2.Beyond first relapse
3.Primary refractory disease
4.Post autologous HSCT
5.Previous treatment with CD20 monoclonal antibody & anthracycline
6.At least one positive lesion on CT/PET scan
7.Biopsy proven disease
Applicable to all patients
1.Documentation of CD19 tumour expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry or on lymph node by immunohistochemistry
2.Adequate bone marrow, renal, hepatic, pulmonary & cardiac function
3.ECOG performance status of 0 or 1 or Lansky (age <16 years) performance status = 70 at screening
Other inclusion criteria apply as per clinical trial protocol.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Adverse events (AEs), specifically cytokine release syndrome (CRS) and Immune Effector cell associated Neurotoxicity Syndrome (ICANS) and Treatment Related Mortality (TRM) after IMN-003A cell infusion as a competitive event up to 3 months. <br/ ><br>2.Disease-specific response criteria including, but not limited to: <br/ ><br>•B-ALL: CR, CRi, MRD at 3 months <br/ ><br>•B-NHL: CR, PR at 3 months <br/ ><br>Timepoint: Baseline, 3 months and 12 months <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Disease response assessment of Minimal Residual Disease MRD, Progression Free Survival PFS, Overall Survival OS and Duration of Response DOR at 12m. <br/ ><br>2.Safety of IMN-003A as determined by Incidence of adverse events (AEs) and abnormal laboratory test results for duration of study. <br/ ><br>Timepoint: 12m