Anti-CD19 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphomas

Phase 1

• Conditions: Acute Lymphoblastic Leukemia ,Lymphomas
• Interventions: Biological: Anti-CD19 CAR-T

• Registration Number: NCT04196205
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

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.

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12
• Primary Completion: 2020-08-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anti-CD19 CAR-T	Anti-CD19 CAR-T	Anti-CD19 CAR-T

Primary Outcome Measures

Name	Time	Method
Overall responce rate(ORR)	2 years	Assessment of ORR (ORR = CR+PR ) at 2 months of treatment
Overall survival (OS)	2 years	Assessment of OS(Overall survival) at 6 months of treatment
Progression-free survival (PFS)	2 years	Assessment of PFS(Progression-free survival ) at 6 months of treatment
minimal residual disease（MRD）	2 years	Assessment of MRD negative overall response rate at 3 months of treatment

Secondary Outcome Measures

Name	Time	Method
Safety (incidence of adverse events defined as dose-limited toxicity)	Study treatment until Week 24	Occurrence of study related adverse events defined as NCI CTCAE 4.0 \> grade 3 possibly, probably, or definitely related to study treatment.
Expression of CD19 CART cells	2 years	Expression of CD19 CART cells detected by flow cytometry in blood and bone marrow.
Detection of CD19 CART cells	2 years	Detection of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).

Trial Locations

Locations (1)

The First Affiliated Hospital of Nangchang University; 🇨🇳 Nanchang, Jiangxi, China