Condition or disease | Intervention/treatment | Phase |
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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 |
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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).
EXPLORATORY OBJECTIVES:
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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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, 2020 |
Estimated Primary Completion Date : | August 31, 2022 |
Estimated Study Completion Date : | August 31, 2023 |
Arm | Intervention/treatment |
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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.
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Biological: Autologous CD19/CD22 Chimeric Antigen Receptor T-cells
Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Fludarabine Given IV
Other Name: Fluradosa
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Ages Eligible for Study: | 6 Months to 70 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
For patients with history of allogenic stem cell transplantation
Exclusion Criteria:
Contact: Jin Seon Im | 832-750-1502 | jim@mdanderson.org |
United States, Texas | |
M D Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Contact: Jin Seon Im 832-750-1502 jim@mdanderson.org | |
Principal Investigator: Jin Seon Im |
Principal Investigator: | Jin S Im | M.D. Anderson Cancer Center |
Tracking Information | |||||
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First Submitted Date ICMJE | July 19, 2019 | ||||
First Posted Date ICMJE | July 23, 2019 | ||||
Last Update Posted Date | June 19, 2020 | ||||
Estimated Study Start Date ICMJE | November 30, 2020 | ||||
Estimated Primary Completion Date | August 31, 2022 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||
Descriptive Information | |||||
Brief Title ICMJE | Modified Immune Cells (CD19-CD22 CAR T Cells) in Treating Patients With Recurrent or Refractory CD19 Positive, CD22 Positive Leukemia or Lymphoma | ||||
Official Title ICMJE | Phase I/II Study of Dual CD19-CD22 Chimeric Antigen Receptor (CAR) T Cells in Patients With Advanced CD19+ CD22+ Lymphoid Malignancies | ||||
Brief Summary | This phase I/II trial studies the side effects and best dose of modified immune cells called CD19-CD22 chimeric antigen receptor (CAR) T cells in treating patients with CD19 positive(+), CD22+ B-acute lymphoblastic leukemia, chronic lymphocytic leukemia, or non-Hodgkin's lymphoma that has come back (recurrent) or does not respond to treatment (refractory). T-cells are collected from the patient and genetic materials called "chimeric antigen receptors (CAR)" are transferred to the collected T-cells. The CAR T-cells are then infused back to the patient's body. Giving CD19- CD22 CAR T cells after chemotherapy may help to control the disease. | ||||
Detailed Description |
PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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). EXPLORATORY OBJECTIVES: 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE | 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.
Interventions:
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Not yet recruiting | ||||
Estimated Enrollment ICMJE |
30 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | August 31, 2023 | ||||
Estimated Primary Completion Date | August 31, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Months to 70 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04029038 | ||||
Other Study ID Numbers ICMJE | 2019-0042 NCI-2019-04229 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2019-0042 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | M.D. Anderson Cancer Center | ||||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Collaborators ICMJE | National Cancer Institute (NCI) | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | June 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |