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Clinical Trial NCT03407859 for Therapy Related Leukemia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL Early Phase 1 100

Recruiting
Clinical Trial NCT03407859 is designed to study Treatment for Therapy Related Leukemia. It is a Early Phase 1 interventional study that is recruiting, having started on 18 January 2016, with plans to enroll 100 participants. Led by Zhujiang Hospital, it is expected to complete by 31 March 2025. The latest data from ClinicalTrials.gov was last updated on 15 March 2024.
Brief Summary
CD19-negative B-ALL relapses after CD19 CAR T-cell treatment have occurred in some patients. CD20/CD22/CD10 is still expressed in CD19 negative B-ALL cells which means these CD molecules may become new targets in treatment of CD19-negative relapse of B-ALL. Thus sequential treatment with CD20/CD22/CD10-CART after CD19-CART treatment in relapsed/refractory B-ALL will kill and eliminate CD19 negative B-ALL cells and pr...Show More
Detailed Description
B-cell acute lymphoblastic leukemia is the most common type of leukemia and the prognosis of relapsed/refractory B-ALL is poor. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. CD19 CAR-T is the most commonly used engineered T cell in B-ALL. The treatment effect is significant and far more than traditional therapy in relapsed/refractory B-ALL. However, the re...Show More
Official Title

Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment Base on MRD in Relapsed/Refractory B-ALL

Conditions
Therapy Related Leukemia
Other Study IDs
  • 2016-XYNK-002
NCT ID Number
NCT03407859
Start Date (Actual)
2016-01-18
Last Update Posted
2024-03-15
Completion Date (Estimated)
2025-03-31
Enrollment (Estimated)
100
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
CD19-CART
CD20-CART
CD10-CART
CD22-CART
Relapsed/Refractory B-ALL
MRD
CD70-CART
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Sequential
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalSequential therapy with different CART
Sequential therapy With different CART including one kind of CD20/CD22/CD10-CART After CD19-CART therapy in CD19-negative relapse ALL patients, subjects will receive 1-5 x 10\^6/Kg transduced CAR T cells at one time.
Sequential Treatment With different CART
Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Adverse events that Are related to treatment
Determine the toxicity profile of the CD19-targeted and CD20/CD22/CD10-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
2 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Estimate 2 year overall survival(OS) after infusion of CD19-CART and sequential treatment
To estimate 2 year overall survival(OS) after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
2 years
Estimate relapse rate after infusion of CD19-CART and sequential treatment
To estimate relapse rate after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
4 years
Estimate 2 year progression free survival after infusion of CD19-CART and sequential treatment
To estimate 2 year progression free survival (PFS) after CD19-CART infusion and sequential treatment with Relapsed/Refractory B-ALL
2 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Relapsed/Refractory B-ALL patients
  2. Did not achieve complete remission after 2 times of standard plan chemotherapy
  3. Relapsed after first induction chemotherapy
  4. Did not response to chemotherapy before HSCT or relapsed after HSCT
  5. Cannot receive allo-HSCT or refuse to receive allo-HSCT
  6. Cell phenotype is CD19 and CD20/CD22/CD10/CD70 positive (single or combined)
  7. Estimated survival time is more than 3 months in leukemia
  8. Volunteered for this clinical trail and signed a consent form

  1. MRD was negative while the cell phenotype was CD19 expressed
  2. Patients with severe insufficient cardiac, pulmonary and hepatorenal functions
  3. Patients with severe mental illness, neurological disease or infectious disease
  4. Patients with GVHD was taking immunosuppressants
  5. Pregnant or lactating women
  6. Patients have received other genetic therapy products
  7. Transfection efficiency was less than 30%
  8. Any situation may do harm to the subjects or interfere the results
Zhujiang Hospital logoZhujiang Hospital
Nanfang Hospital, Southern Medical University logoNanfang Hospital, Southern Medical University
Study Central Contact
Contact: Yuhua Li, Ph.D, 86-20-61643188, [email protected]
Contact: Sanfang Tu, Ph.D, 86-20-62782322, [email protected]
1 Study Locations in 1 Countries

Guangdong

Southern Medical University Zhujiang Hospital, Guangdong, Guangdong, 510000, China
Yuhua Li, PhD, Contact
Recruiting