CA0881000 (A Phase 2, Open-Label, Multicenter Study of Arlocabtagene Autoleucel (BMS-986393), a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL))

IRB Number: STU00221233
ClinicalTrials.gov Identifier: NCT06297226
PI Name: Seema Singhal, MD
Eligibility Criteria:

  • Participant must have documented diagnosis of MM as per IMWG criteria.
  • Participant must have received at least 3 prior LOT.
  • Participant must have received at least 3 prior classes of MM treatment.
  • Participant must have undergone at least 2 consecutive cycles of treatment for each treatment class (except for CAR T cell therapy), unless PD was the best response to the regimen or in the event of unacceptable toxicity.
  • Participant must have documented disease progression (as per IMWG 2016 criteria) during or after their last antimyeloma regimen.

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

Principal Investigator

Seema Singhal, MD

Seema Singhal, MD

Primary Specialty: Hematology
View Full Profile

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
View Full Profile

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), 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: 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

Reem Karmali, MD

Primary Specialty: Hematology and Medical Oncology
View Full Profile