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

Phase 1

• Conditions: Relapsed or Refractory Multiple Myeloma
• Interventions: Biological: Autologous BCMA CAR-T cells and CD19 CAR-T cells

• Registration Number: NCT04194931
• Lead Sponsor: The First Affiliated Hospital of Nanchang University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2019-12
• Study Start: 2019-12-01
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mixed BCMA/CD19 CAR-T Transfer	Autologous BCMA CAR-T cells and CD19 CAR-T cells	Subjects with BCMA/CD19+ multiple myeloma will be infused with CD19-targeting CAR T Cells and BCMA-targeting CAR T Cells in one time or in parts

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	2 year	Assessment of Progression-free survival (PFS) at 6 months of treatment
Overall survival (OS)	2 year	Assessment of overall survival (OS) at 6 months of treatment
minimal residual disease（MRD）	2 year	Assessment of MRD negative overall response rate at 3 months of treatment
Overall response rate (ORR)	2 year	Assessment of ORR (ORR = sCR+CR+VGPR+PR ) at 1 months of treatment

Secondary Outcome Measures

Name	Time	Method
Expression of CD19 CART cells	2 year	Expression of CD19 CART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR) and by flow cytometry.
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.

Trial Locations

Locations (1)

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