IRB Number: STU00220439
ClinicalTrials.gov Identifier: NCT05878184
PI Name: Reem Karmali, MD
Eligibility Criteria:
Diagnosis of NHL (WHO 2016 criteria) or CLL (iwCLL criteria), including: Large B cell lymphoma, including diffuse large B cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), primary mediastinal large B cell lymphoma, high-grade B cell lymphoma, follicular lymphoma Grade 3B, Follicular lymphoma, Marginal zone lymphoma, Mantle cell lymphoma, CLL or small lymphocytic lymphoma (SLL).

• Relapsed/refractory disease after at least 2 regimens per standard of care or after autologous stem cell transplant (ASCT).
• Subjects with bulky disease will be allowed in dose expansion but not dose escalation.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Exclusion: Prior CD19-directed therapy including CD19-directed CAR T cell treatment or other CD19-directed antibody or cell therapy (e.g., NK cell). (Part 2 dose expansion only – prior approved CD19-directed CAR T cell therapy required).

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

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.

IRB Number: STU00218807
ClinicalTrials.gov Identifier: NCT04420754
PI Name: Jochen Lorch, MD
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.

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.

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.

IRB Number: STU00215064
ClinicalTrials.gov Identifier: NCT05202782
PI Name: Reem Karmali, MD
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.