Study of CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell
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|ClinicalTrials.gov Identifier: NCT03019055|
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|CLL/SLL Lymphomas Non-Hodgkin's B-Cell||Biological: CAR-20/19-T||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||
The study is divided into two phases. Phase 1 and Phase 1b. Phase 1: consists of 2 cohorts; dose escalation and dose expansion. The CAR-T cells were given over 2 days.
In the phase 1 portion, there will be a dose escalation cohort to determine the safe CAR-20/19-T cell dose in patients with CLL/SLL and NHL. Once the desired dose has been identified there will be a 6 patient dose expansion phase at the specified dose level.
Phase 1b: Consists of 2 cohorts; dose expansion and the exploratory dose given as a single dose.
In the Phase 1b portion of the study, we will test the safety of unfractionated CAR-T cells utilizing the safe dose identified in the phase 1 portion (2.5 x 10^6 cells/kg). We will also add an exploratory dose level at 5 x 10^6 cells/kg.
|Masking:||None (Open Label)|
|Official Title:||Phase 1/1b Study of Redirected Autologous T Cells Engineered to Contain an Anti CD19 and Anti CD20 scFv Coupled to CD3ζ and 4-1BB Signaling Domains in Patients With Relapsed and/or Refractory CD19 or CD20 Positive B Cell Malignancies|
|Actual Study Start Date :||October 16, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2021|
Experimental: CAR-20/19-T cells
Dose Escalation Phase: CAR-20/19-T transduced with a lentiviral vector to express an anti CD19 and anti CD20 tandem receptor coupled to CD3ζ and 4-1BB signaling domains will be administered by IV injection. Patients will receive one of four dose levels based the study protocol. Cells will be given over 2 days, 30% of cells infused on Day 0 and 70% of cells infused on Day 1
CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
Dose Level -1: 1 x 10^5 CAR-20/19-T cells/kg
Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)
Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg
Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)
Expansion Dose Level: 2.5 x 10^6 cells/kg
Exploratory Dose Level: 5 x 10^6 cells/kg
- Number of Adverse Events after CAR 20/19-T cell infusion [ Time Frame: Within the first 28 days after infusion ]Determine the toxicity profile of CAR 20/19-T cell therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019055
|Contact: Nirav Shah, MDemail@example.com|
|Contact: Debra Pastorek, RNfirstname.lastname@example.org|
|United States, Wisconsin|
|Froedtert Hospital & Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Nirav Shah, MD|
|Principal Investigator:||Nirav Shah, MD||Medical College of Wisconsin|