Health Condition 1: C851- Unspecified B-cell lymphoma
Conditions
Interventions
Intervention1: Mycabtagene autoleucel (MyCART-01): MyCART-01 is a CD19-directed T cell immunotherapy.
A single dose of MyCART-01 contains 0.2 to 5.0 x 106 CAR-positive viable T cells per kg of body we
Sponsors
Micro CRISPR Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Non Hodgkinâ??s Lymphoma: 1)Non Hodgkins Lymphoma Patients with age greater than or equal to 18 years. 2)Patients with relapsed or refractory B Cell NHL with histologically confirmed diagnosis of one of the following a)DLBCL NOS b)high grade B Cell lymphoma with MYC and BCL2 and or BCL6 rearrangements c) transformed FL d)mantle cell lymphoma e)grade 3b FL f)Richters transformation of CLL g)Other forms of B cell NHL Note: i)For refractory disease patients must have progressive disease on last therapy, or have stable disease following at least 2 lines of therapy with duration of stable disease of less than or equal to 6 months ii)For patients with transformed FL, patients must have received at least one line of chemotherapy for disease after transformation to DLBCL and have progressed or relapsed within 12 months 3) Refractory or relapsed disease, to prior first line therapy, including an anti CD20 monoclonal antibody and an anthracycline containing regimen 4) Patients with prior autologous hematopoietic stem cell transplant must not have traces of related toxicities. 5) At least 1 measurable lesion that is fluorodeoxy glucose positron emission tomography positive, as defined by Lugano criteria Note: Previously irradiated lesions will be considered measurable only if progression is documented following g completion of radiation therapy. Acute Lymphoblastic leukemia Acute Lymphoblastic Leukemia: 1)Adult patients of age greater than or equal to 18 years and children of age greater than or equal to 3 years 2)Diagnosed with the histologically confirmed CD19 positive relapsed or refractory adult or pediatric B Cell ALL a)Refractory disease is defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or after completion of induction phase of pediatric regimens or b)Relapsed disease as defined by bone marrow relapse at any point of time after achieving CR 1 3)Philadelphia chromosome positive Ph positive ALL patients 4)Confirmation from central pathology lab i)Documentation of CD19 tumor expression in bone marrow by flow cytometryII ii)Bone marrow with greater than or equal to 5 percent lymphoblasts For all patients: 1)Eastern Cooperative Oncology Group performance status 0 to 1 2)Life expectancy greater than or equal to 12 weeks 3)Patients with absolute lymphocyte count of greater than or equal to 0.2 into 109 per L 4)Female patients of childbearing potential post menarcheal with an intact uterus and at least 1 ovary, who are less than 1 year postmenopausal must agree to use acceptable method of contraception from enrollment through at least 12 months after CAR T infusion. Male patients must agree to use effective contraception from enrollment through at least 12 months after CAR T infusion 5)Adequate organ function based on investigators discretion but not limited to the following points: i)Renal: Estimated glomerular filtration rate greater than 50 ml min 1.73 m2 ii)Liver: Aspartate transaminase or alanine transaminase less than 3 upper limit of normal total bilirubin less than 1.5 ULN for patients with Gilberts syndrome total bilirubin less than 3 mg dL iii)Cardiac: Hemodynamically stable and left ventricle ejection fraction greater than or equal to 45percent
Exclusion criteria
Exclusion criteria: 1)Eligible for and agrees to allogeneic HSCT 2)Treatment with the following therapies as described below a) Prior treatment with any gene therapy or genetically modified cell therapy, including CAR-T Cells b) Prior treatment with a CD19-directed antibody, bispecific T Cell engager, or antibody drug conjugate, unless there is confirmed CD19 expression by immunohistochemistry or flow cytometry after progression or relapse following most recent CD19 directed treatment. 3) Prior allogenic HSCT 4)Prior anaphylactic reaction to Cyclophosphamide, Fludarabine or any of the excipients of CART product 5) History of a seizure disorder, cerebrovascular ischemia or hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement 6)Unstable angina, clinically significant arrhythmia, or myocardial infarction within 12 months of enrollment 7) Presence of active bacterial, viral, or fungal infection 8)Positive for presence of human immunodeficiency virus type 1 or 2, or active hepatitis B virus orhepatitis C virus infection or other viral infections. Patients with prior history of hepatitis B or C infection who have documented undetectable viral load by quantitative polymerase chain reaction or nucleic acid testing may be permitted 9) Patients have active SARS COV-2 positive RT PCR test infection at the time of screening. 10) Any condition leading to T Cell depletion, rendering patient unsuitable for CAR T Cell therapy 11) Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely treated and has been in remission for greater than or equal to 5 years 12) Patient underwent radiation therapy before 14 days of enrollment 13) Use of systemic anti tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment. An exception is made for prior inhibitory or stimulatory immune checkpoint molecule therapy, which is prohibited within 3 half lives of enrollment 14) Primary immunodeficiency disorder or active autoimmune disease requiring steroids and or other immunosuppressive therapy 15) Diagnosis of significant psychiatric disorder or other medical condition that, in the opinion of the investigator, could impede the patientâ??s ability to participate in the study 16) Women who are pregnant or breastfeeding 17) Any condition, in opinion of the Investigator or Screening committee, would preclude safe participation of patient in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events, defined as safety evaluation Evaluating the objective response rate (complete response (CR) + partial response(PR)) per the Lugano Response Criteria for malignant lymphoma Evaluating the objective response rate in pediatric and young adult CD19+ relapsed or refractory B cell ALL, based on CR and complete remission with incomplete count recovery (CRi)Timepoint: 30 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluating the objective response rate (complete response (CR) + partial response(PR)) per the Lugano Response Criteria for malignant lymphomaTimepoint: 3 Months;Duration of response Progression-free survival (central read) Disease control rate [CR+PR+ stable disease (SD)] Only for ALL patient: Overall survival Frequency and severity of adverse events and clinically significant laboratory abnormalities Timepoint: 2 Years | — |
Countries
India
Contacts
Public ContactMukesh Kumar Saroj
Meril Life Science Pvt. Ltd
Outcome results
None listed