Health Condition 1: C910- Acute lymphoblastic leukemia [ALL] Health Condition 2: C859- Non-Hodgkin lymphoma, unspecified
Conditions
Interventions
Intervention1: antiCD19 CAR positive T cells: Dose is 0.1 million to 5 million CAR positive T cells per Kg Body Weight.
Route of administration is
Intravenous
Frequency-The treatment is given over a
Sponsors
Immuneel Therapeutics Private Limited
Eligibility
Inclusion 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-Hodgkinâ??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 = 70 at screening Other inclusion criteria apply as per clinical trial protocol.
Exclusion criteria
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-Hodgkinâ??s Lymphoma 1.History of Richterâ??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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2.Disease-specific response criteria including, but not limited to: â?¢B-ALL: CR, CRi, MRD at 3 months â?¢B-NHL: CR, PR at 3 months Timepoint: Baseline, 3 months and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease response assessment of Minimal Residual Disease MRD, Progression Free Survival PFS, Overall Survival OS & Duration of Response DOR at 6 m & 12mTimepoint: 6m & 12m | — |
Countries
India
Contacts
Public ContactDr. Anand Eswaraiah
Immuneel Therapeutics
Outcome results
None listed