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

NCT04196205 | Unknown Phase 1 DMC

• 1 other identifier: 2018027
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Lymphoblastic Leukemia ,Lymphomas

Keywords

acute lymphoblastic leukemia ;Lymphomas

Outcome Measures

Primary Outcomes (4)

• Overall responce rate(ORR)

  Assessment of ORR (ORR = CR+PR ) at 2 months of treatment

  2 years

• Overall survival (OS)

  Assessment of OS(Overall survival) at 6 months of treatment

  2 years

• Progression-free survival (PFS)

  Assessment of PFS(Progression-free survival ) at 6 months of treatment

  2 years

• minimal residual disease（MRD）

  Assessment of MRD negative overall response rate at 3 months of treatment

  2 years

Secondary Outcomes (3)

• Safety (incidence of adverse events defined as dose-limited toxicity)

  Study treatment until Week 24

• Expression of CD19 CART cells

  2 years

• Detection of CD19 CART cells

  2 years

Study Arms (1)

Anti-CD19 CAR-T

EXPERIMENTAL

Anti-CD19 CAR-T

Biological: Anti-CD19 CAR-T

Interventions

Anti-CD19 CAR-T BIOLOGICAL

1 - 2×10\^6 Anti-CD19 CAR-T cells/kg body weigh

Anti-CD19 CAR-T

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Affiliated Hospital of Nanchang University: lead

Study Sites (1)

The First Affiliated Hospital of Nangchang University

Nanchang, Jiangxi, 330006, China

RECRUITING

Central Study Contacts

Fei Li, M.D., Ph.D.

CONTACT

+86-139-7003-8386; yx021021@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.,Ph.D.

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: December 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: December 12, 2019

Record last verified: 2019-12

Locations

CN (1)