CAR T-Cell Clinical Trials
An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-Directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-Directed CAR T-cell Therapy
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.
Principal Investigator
Reem Karmali, MD
Primary Specialty: Hematology and Medical Oncology
A Phase 2, Open-Label, Single-Arm, Multicohort, Multicenter Trial to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects with Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphoma (NHL) (Transcend FL) - JCAR017-FOL-001
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)
For more information, read the study details on clinicaltrials.gov.
Principal Investigator
Reem Karmali, MD
Primary Specialty: Hematology and Medical Oncology
An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)
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.
Principal Investigator
Shuo Ma, MD, PhD
Primary Specialty: Hematology and Medical Oncology
A Phase 1 study evaluating SC291, a hypoimmune allogeneic CD19-directed CAR T cell therapy, in relapsed and/or refractory B-cell malignancies (ARDENT)
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.
Principal Investigator
Reem Karmali, MD
Primary Specialty: Hematology and Medical Oncology
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
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: 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.
Principal Investigator
Jochen H. Lorch, MD
Primary Specialty: Hematology and Medical Oncology
Phase I/II, open label, multicenter study of Rapcabtagene autoleucel in adult patients with 3L+ DLBCL, r/r ALL and 1L HR LBCL
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.
Principal Investigator
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:
- 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.
Principal Investigator
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, 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.