Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

Relapsed or Refractory Multiple Myeloma Clinical Trial

Official title:

Study Evaluating the Safety and Efficacy With Sequential Infusion of Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04194931
• Other study ID #: 2018028
• Status: Recruiting
• Phase: Phase 1
• Start date: December 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: The First Affiliated Hospital of Nanchang University
• Contact: Fei LI, M.D.;Ph.D.
• Phone: +86-139-7003-8386
• Email: yx021021[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.

Description:

CD19 has been extensively evaluated as a therapeutic target for relapsed or refractory multiple myeloma by chimeric antigen receptor T cell therapy,this is a single arm, open-label, single center study to preliminary explore the safety, tolerability and cellular pharmacokinetics of Anti-BCMA and Anti-CD19 CAR-T cells in the treatment of relapsed or refractory multiple myeloma.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female aged 18-70 years old

2. Estimated Survival time > 12 weeks

3. Relapsed and refractory multiple myeloma were confirmed by physical examination, pathological examination, laboratory examination and imaging

4. Chemotherapy failure or recurrent multiple myeloma

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 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Biological:
• Autologous BCMA CAR-T cells and CD19 CAR-T cells
Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nangchang University	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Nanchang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR)	Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment	2 year
Primary	minimal residual disease(MRD)	Assessment of MRD negative overall response rate at 3 months of treatment	2 year
Primary	Progression-free survival (PFS)	Assessment of Progression-free survival (PFS) at 6 months of treatment	2 year
Primary	Overall survival (OS)	Assessment of overall survival (OS) at 6 months of treatment	2 year
Secondary	Safety (incidence of adverse events defined as dose-limited toxicity)	Occurrence of study related adverse events defined as NCI CTCAE 4.0 > grade 3 possibly, probably, or definitely related to study treatment.	Study treatment until Week 24
Secondary	Expression of CD19 CART cells	Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.	2 year