A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:

Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Multiple Myeloma With Dual CAR-T Cells Targeting CD38 and BCMA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03767751
• Other study ID #: CHN-PLAGH-BT-037
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: December 5, 2018
• Est. completion date: December 5, 2022

Study information

• Verified date: December 2018
• Source: Chinese PLA General Hospital
• Contact: YaJing Zhang
• Phone: 86-10-55499341
• Email: plagh[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.

Description:

1. PRIMARY OBJECTIVES:

1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.

2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.

2. SECONDARY OBJECTIVES:

1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.

2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0:

1-5x10e6/kg total dose on day 0.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 5, 2022
• Est. primary completion date: December 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Male or female participant

2. 12 Years to 70 Years (Child, Adult, Senior)

3. Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%)

4. Estimated life expectancy = 12 weeks (according to investigator's judgement)

5. Eastern Cooperative Oncology Group (ECOG) performance status = 1

6. Adequate organ function

Exclusion Criteria:

1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease

2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis

3. Richter's syndrome

4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening

5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy

6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible

7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening

8. Patient has an investigational medicinal product within the last 30 days prior to screening

9. Previous treatment with investigational gene or cell therapy medicine products

10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary

11. Pregnant or nursing women

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Biological:
• Dual Specificity CD38 and bcma CAR-T Cells
1) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg

Locations

Country	Name	City	State
China	Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability		24weeks
Primary	MTD of dual specificity CD38 and BCMA CAR-T cells	The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells	4 weeks
Primary	Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes		24 weeks
Secondary	Six-month Objective response rate of complete remission and partial remission		24 weeks
Secondary	Six-month Overall survival		24 weeks
Secondary	Six-month Progression free survival		24 weeks