Clinical trial NCT04196205: Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
Official title: Study Evaluating the Safety and Efficacy With Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lymphoblastic Leukemia ,Lymphomas
Keywords: acute lymphoblastic leukemia ;Lymphomas
Lead sponsor: The First Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with relapsed or refractory acute lymphoblastic leukemia and Lymphomas.

Detailed description: CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory B cell malignancy by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to determine the safety and efficacy of Anti-CD19 CAR-T cells in patients with refractory acute lymphoblastic leukemia and Lymphomas.

Eligibility criteria: Inclusion Criteria: Subjects diagnosed as Relapsed or Refractory acute lymphoblastic leukemia and Lymphomas ，and have no effective treatment option (such as autograft or allogeneic stem cell transplantation) and estimated survival time of the current treatment \< 2 years, The specific requirements are as follows:

1. Male or female aged 18-70 years old ;
2. Estimated Survival time \> 12 weeks;
3. Relapsed and refractory acute lymphoblastic leukemia and lymphoma were confirmed by physical examination, pathological examination, laboratory examination and imaging;
4. Chemotherapy failure or recurrent acute lymphoblastic leukemia and Lymphomas;
5. Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level;
6. Bilirubin\<2.0mg/dl;
7. Karnofsky Performance Status\>50% at the time of screening;
8. Adequate pulmonary, renal, hepatic, and cardiac function;
9. Fail in autologous or allogenic haemopoietic stem cell transplantation;
10. Not suitable for stem cell transplantation conditions or abandoned due to conditions;
11. Free of leukocytes removal contraindications;
12. Voluntarily join CAR-T clinical trial ,Understand and sign written informed consent.

Exclusion Criteria:

1. The patient is a pregnant or breastfeeding woman, or is a woman with a pregnancy plan within six months;
2. Patients have infectious diseases (such as HIV, active tuberculosis, etc.);
3. The patient is an active hepatitis B or hepatitis C infection;
4. Feasibility assessment proves that the efficiency of transduction of lymphocyte is below 10% or the lymphocyte cannot be propagated ;
5. Abnormal vital signs;
6. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation;
7. Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2;
8. General infection or local severe infection, or other infection that is not controlled;
9. Dysfunction in lung, heart, kidney and brain;
10. Severe autoimmune diseases;
11. Other symptoms that are not applicable for CAR-T.

Primary outcomes:
measure: Overall responce rate(ORR)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Progression-free survival (PFS)
timeFrame: 2 years
measure: minimal residual disease（MRD）
timeFrame: 2 years
Secondary outcomes:
measure: Safety (incidence of adverse events defined as dose-limited toxicity)
timeFrame: Study treatment until Week 24
measure: Expression of CD19 CART cells
timeFrame: 2 years
measure: Detection of CD19 CART cells
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nangchang University
state: Jiangxi
Study officials:
References: