Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04029038|
Recruitment Status : Not yet recruiting
First Posted : July 23, 2019
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|CD19 Positive CD22 Positive Minimal Residual Disease Progressive Disease Recurrent B Acute Lymphoblastic Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Non-Hodgkin Lymphoma Refractory B Acute Lymphoblastic Leukemia Refractory Chronic Lymphocytic Leukemia Refractory Non-Hodgkin Lymphoma||Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells Drug: Cyclophosphamide Drug: Fludarabine||Phase 1 Phase 2|
I. To determine the safety of infusion with chimeric antigen receptor T cells targeting CD19 and CD22.
II. To find the recommended phase II dose for recurrent/refractory CD19+CD22+ B cell malignancies.
I. To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19 and CD22.
II. To assess other response variables including minimal residual disease (MRD) negative remission, overall survival (OS), and event free survival (EFS).
I. To evaluate the immune reconstitution and persistence of CAR T cells for one year post infusion.
OUTLINE: This is a phase I, dose escalation study of autologous CD19/CD22 chimeric antigen receptor T-cells (CD19-CD22 CAR T cells) followed by a phase II study.
Patients receive standard of care cyclophosphamide intravenously (IV) over 30 minutes and fludarabine IV over 30 minutes on days -5, -4, and -3, and then receive CD19-CD22 CAR T cells IV on day 0. Patients with relapsed or persistent disease after a protocol assessment may receive a second infusion of CD19-CD22 CAR T cells.
After completion of study treatment, patients are followed up at 1, 2, 3, 6, and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies|
|Estimated Study Start Date :||November 30, 2019|
|Estimated Primary Completion Date :||August 31, 2022|
|Estimated Study Completion Date :||August 31, 2023|
Experimental: Treatment (CD19-CD22 CAR T cells)
Patients receive standard of care cyclophosphamide IV over 30 minutes and fludarabine IV over 30 minutes on days -5, -4, and -3, and then receive CD19-CD22 CAR T cells IV on day 0. Patients with relapsed or persistent disease after a protocol assessment may receive a second infusion of CD19-CD22 CAR T cells.
Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells
Other Name: Fluradosa
- Optimal chimeric antigen receptor (CAR) T cell dose level [ Time Frame: Up to 30 days ]Dose-finding will be done using the sequentially adaptive phase I-II EffTox method.
- Incidence of adverse events (adverse events) [ Time Frame: Up to 30 days ]Toxicity is defined as a grade 3, 4, or 5 cytokine release syndrome, neurotoxicity, or National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 with onset within 30 days of cell infusion. Adverse events that are considered disease-related (not suspected of relationship to CD19-CD22 -CAR T cells) will not be considered dose-limiting toxicities. Only those AEs that occur during the first 30 days after infusion, which are suspected to be related to conditioning lymphodepletion chemotherapy regimen and/or CD19 -CD22-CAR T cells (any component of the treatment regimen), and meet the following criteria, will be used in the definition of toxicity. Hematologic toxicities will not be considered in the definition of toxicity, as pancytopenia is a common toxicity with this regimen.
- Efficacy in complete response (CR) or partial response [ Time Frame: Day 30 post cell infusion ]Efficacy is defined as the patient being alive and in complete response (CR) or partial response (PR) at day 30 post cell infusion.
- Progression-free survival [ Time Frame: Up to 1 year post T-cell infusion ]Unadjusted distributions of the time-to-event outcomes will be estimated using the method of Kaplan and Meier and their relationship to prognostic covariates and T-cell dose level will be evaluated by Bayesian piecewise exponential survival regression.
- Overall survival [ Time Frame: Up to 1 year post T-cell infusion ]Unadjusted distributions of the time-to-event outcomes will be estimated using the method of Kaplan and Meier and their relationship to prognostic covariates and T-cell dose level will be evaluated by Bayesian piecewise exponential survival regression.
- Immune reconstitution [ Time Frame: Up to 1 year post T-cell infusion ]These longitudinal values will be evaluated graphically and cross-tabulated with dose.
- Persistence of CAR T-cells [ Time Frame: Up to 1 year post T-cell infusion ]These longitudinal values will be evaluated graphically and cross-tabulated with dose.
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): NCT04029038
|Contact: Jin Seon Imemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Not yet recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jin Seon Im 832-750-1502 firstname.lastname@example.org|
|Principal Investigator: Jin Seon Im|
|Principal Investigator:||Jin S Im||M.D. Anderson Cancer Center|