An Adaptive Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of Axicabtagene Ciloleucel versus Standard of Care Therapy as First-Line Therapy in Subjects with High-Risk Large B-Cell Lymphoma (ZUMA-23)

IRB Number: STU00219827
ClinicalTrials.gov Identifier: NCT05605899
PI Name: Reem Karmali, MD
Eligibility Criteria:
Histologically confirmed LBCL, High-risk disease (IPI of 4 or 5), Ann Arbor III or IV, ECOG 0-2, measurable disease, has received only 1 cycle of R-chemotherapy, no prior treatment for LBCL other than 1 cycle of R-chemotherapy.

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Reem Karmali, MD

Reem Karmali, MD

Primary Specialty: Hematology and Medical Oncology


A Multicenter Phase 1 Study of AIC100 CAR T Cells in Relapsed and/or Refractory Advanced Thyroid Cancer and Anaplastic Thyroid Cancer (Drug 19-12021154)

IRB Number: STU00218807
ClinicalTrials.gov Identifier: NCT04420754
PI Name: Dr. Jochen Lorch
Eligibility Criteria:

  • Patients must have thyroid cancer that expresses ICAM-1 gene
  • Measurable disease by PET/CT or CT
  • ECOG performance status of 0-2
  • Life expectancy greater than 8 weeks
  • Cannot have prior treatment with investigational gene therapy or CAR T cell therapy
  • Cannot have evidence of another malignancy within 2 years prior to Screening

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Jochen H. Lorch, MD

Jochen H. Lorch, MD

Primary Specialty: Hematology and Medical Oncology


Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL

IRB Number: STU00215546
ClinicalTrials.gov Identifier: NCT03960840
PI Name:  Shira Dinner, MD
Eligibility Criteria:

  • ALL: r/r CD19-positive ALL with morphologic disease in the bone marrow (≥ 5% blasts) and including at least 1 of the following: After allogeneic HSCT, After 2 or more lines of treatment, primary refractory disease, first relapse occurring within 12 months from first remission, or Patients with Philadelphia chromosome-positive ALL must have failed at least 2 different tyrosine kinase inhibitors
  • Cannot have an allogeneic HSCT within 12 weeks prior to screening Prior CD19-directed therapy (with the exception of blinatumomab for patients with ALL)
  • Cannot have a prior administration of a genetically modified cellular product

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Shira N. Dinner, MD

Shira N. Dinner, MD

Primary Specialty: Hematology and Medical Oncology


A multi-center single arm Phase II study to evaluate the safety and efficacy of genetically engineered autologous cells expressing anti-CD20 and anti-CD19 specific chimeric antigen receptor in subjects with relapsed and/or refractory diffuse large B cell lymphoma

IRB Number: STU00214654
ClinicalTrials.gov Identifier: NCT04792489
PI Name:  Reem Karmali, MD
Eligibility Criteria:

  • Histologically confirmed DLBCL or associated subtype
  • Relapsed or refractory disease after 2 or more lines of chemotherapy including rituximab and anthracycline and either having failed autologous stem cell transplant (ASCT), or being ineligible for or not consenting to ASCT
  • ECOG performance status of 0 or 1
  • Measurable disease according to Lugano criteria
  • No clinical suspicion of central nervous system lymphoma

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Reem Karmali, MD

Reem Karmali, MD

Primary Specialty: Hematology and Medical Oncology


TAK-007-2001: A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

IRB Number: STU00216463
ClinicalTrials.gov Identifier: NCT05020015
PI Name: Reem Karmali
Eligibility Criteria:

  • Patients with a diagnosis of previously treated r/r histologically proven CD19-expressing disease of the following types:
    • a) LBCL, including the following: Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS); High-grade B-cell lymphoma (HGBL) with MYC and BCL2 and/or BCL6 rearrangement; HGBL NOS without translocations; DLBCL arising from iNHL including FL or MZL; T-cell/histiocyte-rich large B-cell lymphoma; DLBCL associated with chronic inflammation; Epstein-Barr virus–positive DLBCL-NOS; Primary cutaneous DLBCL, leg type; Primary mediastinal large B-cell lymphoma; FL Grade 3B.
    • b) iNHL, including the following: FL Grade 1, 2, 3A; MZL (nodal, extranodal, and splenic).
  • Patients who have measurable disease, defined as at least 1 lesion per the Lugano classification.
  • Patients who have an Eastern Cooperative Oncology Group performance status of 0 or 1
  • Patients who have r/r disease after at least 2 prior lines of systemic therapy
  • Patients who have adequate bone marrow function
  • Patients aged ≥18 years or meeting country definition of adult, whichever is older, at the time of signing the informed consent.

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Reem Karmali, MD

Reem Karmali, MD

Primary Specialty: Hematology and Medical Oncology


Phase II, Single-arm, Open-label, Multicenter study Evaluating the Efficacy of Adjunctive Zanubrutinib and CAR T-cell therapy in Aggressive B-cell Non-Hodgkin’s Lymphoma

IRB Number: STU00215064
ClinicalTrials.gov Identifier: NCT05202782
PI Name: Reem Karmali
Eligibility Criteria:

  • Inclusion Criteria
    • Patients must have a histo-pathologically confirmed diagnosis of an aggressive B-cell non-Hodgkin lymphoma or transformed indolent B-cell lymphoma that is recurrent or refractory to standard therapy with plan to proceed with standard of care (SOC) CAR Tcell therapy.
    • Patients must have measurable disease per Lugano Criteria (2014) (Appendix E)
    • Patients must exhibit an ECOG performance status of 0-2.
    • Patients must have a life expectancy of greater than 12 weeks.
  • Exclusion Criteria
    • Patients with evidence of active disease in the central nervous system (CNS)
    • Patients with HIV
    • Pregnant and nursing mothers
    • Patients unable to swallow oral medication

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Reem Karmali, MD

Reem Karmali, MD

Primary Specialty: Hematology and Medical Oncology


Transcend FL: A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL) 

IRB Number: STU00212069
ClinicalTrials.gov Identifier: NCT04245839
PI Name: Reem Karmalil
Eligibility Criteria: Age of at least 18 years. Diagnosis of Follicular or Marginal Zone Lymphoma, which has either returned or is not responding to your current treatment. Follicular Lymphoma and Marginal Zone Lymphoma are two types of non-Hodgkin lymphoma (NHL). Note: This is only a partial list of eligibility criteria. Please contact the Robert H. Lurie Comprehensive Cancer Center of Northwestern University for complete screening information if you are interested in this clinical trial.

For more information, read the study details on clinicaltrials.gov.

Principal Investigator

Reem Karmali, MD

Reem Karmali, MD

Primary Specialty: Hematology and Medical Oncology