Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia

• Sponsor: Chinese PLA General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04012879
• Collaborator: Shenzhen University General Hospital (Other)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 26
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory acute lymphoblasic leukemia.

Condition or Disease	Intervention/Treatment	Phase
Relapsed Acute Lymphoblastic Leukemia; Refractory Acute Lymphoblastic Leukemia	Combination Product: CD19 CART	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Acute Lymphoblastic Leukemia
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: Apr 30, 2021
• Anticipated Study Completion Date: Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: study group After 6 days of pre-chemotherapy, patients in study group will be injected with CD19CART cell at the dose of 5×10^4 cells/kg in 36-96 hours	Combination Product: CD19 CART; CD19 CART

Outcome Measures

Primary Outcome Measures

1. recovery rate of patients being treated with CD19CAR-T [6 months]

   the recovery rate of patients consists of complete recovery rate and partial recovery rate of patients being treated with CD19 CAR-T

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Diagnosis with Relapsed or refractory acute lymphocyte leukemia with CD19 positive

2. Age 18 to 65 years old, both male and female;

3. Is expected to survive more than 12 weeks;

4. Physical condition is good: 0-1 score ECOG score;

5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;

6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;

2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;

3. Pregnancy and lactation women;

4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;

5. The Investigator believe the patients should not participate in this experiment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shenzhen University General Hospital	Shenzhen		China	518000

Sponsors and Collaborators

• Chinese PLA General Hospital
• Shenzhen University General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Yu, Professor, Chinese PLA General Hospital
• ClinicalTrials.gov Identifier: NCT04012879
• Other Study ID Numbers: HEM-ALL001-CART
• First Posted: Jul 9, 2019
• Last Update Posted: Jul 9, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid

Study Results

No Results Posted as of Jul 9, 2019