IRB Number: STU00220351
ClinicalTrials.gov Identifier: NCT06242834
PI Name: Reem Karmali, MD
Eligibility Criteria:

• Patients must have a histo-pathologically confirmed aggressive B-cell NHL intended for or currently undergoing standard of care ASCT or CAR T-cell therapy. For the purpose of this study, aggressive B-cell NHL histologies should conform to the label indications for the respective CAR-T being utilized.
• For CAR T-cell therapy, patients must have metabolically active disease on PET/CT prior to therapy; For ASCT therapy, patients must be in complete remission.
• ECOG 0-1
• Exclusion: Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137) or prior exposure to EZH2 inhibitors

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

IRB Number: STU00221437
ClinicalTrials.gov Identifier: NCT05972720
PI Name: Reem Karmali, MD
Eligibility Criteria:

• Diagnosis of one of the following: DLBCL not otherwise specified (NOS), including germinal center B-cell (GCB) type or active B-cell (ABC) type, double-hit or triple-hit lymphoma, DLBCL arising from follicular lymphoma, DLBCL arising from marginal zone lymphoma, primary mediastinal (thymic) large B-cell lymphoma, FL Grade 3B.
• Patients must have previously received a CD19-directed CAR T-cell therapy.
• Relapsed/refractory disease defined by PD or SD after last therapy OR relapsed disease following a CR or progressive disease following a PR after the last therapy.
• Patients must have measurable disease.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Exclusion: Patients with a history of CD22-directed therapy for lymphoma.

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

IRB Number: STU00212069
ClinicalTrials.gov Identifier: NCT04245839
PI Name: Reem Karmali, MD
Eligibility Criteria:

• Cohort 3 Extension (2L r/r FL subjects) is open
• Cohort 3 Extension (2L r/r FL): patients must have received no more than 1 prior line of combination systemic therapy, which included an anti-CD20 antibody (eg, rituximab, obinutuzumab) and an alkylating agent, and has relapsed or refractory disease that has progressed within 24 months of initiation of first-line chemoimmunotherapy (POD24) OR must meet at least one of the modified GELF criteria (NCCN, 2019)

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IRB Number: STU00208648
ClinicalTrials.gov Identifier: NCT03331198
PI Name: Shuo, Ma MD PhD
Eligibility Criteria:

• Double-Exposed Monotherapy Expansion (DEME) Cohort - Phase 2
• CLL with an indication for treatment based on the Investigator’s opinion and measurable disease (any of the following: bone marrow involvement by ≥ 30% lymphocytes, peripheral blood lymphocytosis > 5×10^9/L, and/or measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly), OR
• SLL (lymphadenopathy and/or splenomegaly and < 5×10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease defined as at least one lesion ≥ 1.5 cm in the greatest transverse diameter that is biopsy proven SLL).
• DEME cohort ONLY: Subjects with R/R CLL or SLL, irrespective of cytogenetic risk features, must have received at least 2 lines of prior therapy including a BTKi and a BCL2i

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

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.

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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:

• Currently available for R/R ALL, first line (1L) HR LBCL, 3L+ DLBCL
• R/R ALL and 3L+ DLBCL: ECOG 0-1
• 1L HR LBCL ECOG 0-2
• R/R ALL Cohort: R/R or relapsed CD19+ ALL including at least 1 of the following: After ALLO HSCT, after 2 or more lines, primary refractory disease, first relapse within 12 months from first remission. AND morphologic disease in the bone marrow (> 5% blasts).
• 1L HR LBCL Cohort: Histologically confirmed large B-cell non-Hodgkin lymphoma. And
• High risk based on either IPI score of 3-5 or MCY and BCL2 and/or BCL6 rearrangement (DH/TH lymphoma) assessed locally.
• Must have received 2 cycles of frontline therapy with RCHOP or Pola-R-CHP or DA-EPOCH-R. Participants with DH/TH lymphoma must have received at least one cycle (the most recent cycle) of DA-EPOCH-R.
• Participants must have a positive PET per Lugano classification (Deauville PET score of 4 or 5 and overall response of PR/SD) after 2 cycles of frontline CIT.
• 3L+ DLBCL Cohort: Confirmed DLBCL as per local histopath assessment. R/R disease after receiving 2 or more lines of therapy, including anti-CD20 and anthracycline-based chemo, and having progressed or relapsed after auto HSCT (or being ineligible for or not consenting to the procedure).
• Patients who are not in a complete response and have measurable disease at time of enrollment must have nodal lesions > 15 mm in the long axis and/or extranodal lesions.

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

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

• Currently available for DLBCL (NOS, High-grade B cell lymphoma, transformed lymphoma), PCNSL or SCNSL, Mantle Cell Lymphoma (MCL), Richter's Transformation (RT)
• R/R for DLBCL is defined as failure of 2 or more lines of chemo, including rituximab or equivalent, and either having failed ASCT or ineligible.
• CNS cohort: subjects with R/R PCNSL or have failed at least first-line therapy (high dose methotrexate-based therapy) or unable to tolerate therapy. Patients with SCNSL must have relapse or refractory disease after having received at least on prior line (including an anti-CD20 monoclonal antibody).
• MCL cohort: Cohort: Subjects with relapsed/refractory disease after at least one prior systemic treatment (including cytoxic rituximab-based chemo regimen) AND a BTK inhibitor.
• RT cohort: Subject must have relapsed/refractory disease after at least one prior systemic treatment following Richter’s Transformation
• ECOG 0-1 or 2 if decrease is due to lymphoma
• Measurable disease assessed by PET/CT

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.