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Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma | Clinical Trials | Clareo Health

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Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple Myeloma

Clinical Study of Redirected Autologous T Cells With a BCMA-targeted Chimeric Antigen Receptor in Patients With Refractory or Relapsed Multiple Myeloma

NCT03716856•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

A single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.

Detailed Description

This study is designed to determine the safety, tolerability and engraftment potential of anti-BCMA lentivirus-transduced autologous T cells in patients with refractory or relapsed multiple myeloma. Primary objectives: 1. Determine the safety and tolerability of CAR-BCMA T cells (autologous T cells transduced with chimeric antigen receptors recognizing BCMA) in patients with refractory or relapsed multiple myeloma. 2. Observe the cytokinetics of CAR-BCMA T cells. Secondary objectives: 1. Observe the anti-tumor response of CAR-BCMA T cells to refractory or relapsed multiple myeloma (evaluated by diagnostic criteria International Myeloma Working Group (IMWG2014 version) as CR, sCR, ICR, MCR or VGPR). 2. Make an evaluation on the distribution and in vivo survival of CAR-BCMA T cells in peripheral blood, lymph node, and bone marrow. 3. Observe the immunogenicity of CAR-BCMA T cells, and determine if there is anti-BCMA scFv cellular immune response and anti-BCMA scFv humoral immune response. 4. Observe the change of T cell subsets relative to CAR-BCMA T。 (Tcm, central memory T lymphocytes; Tem, effector memory T lymphocytes; Treg, regulatory T lymphocytes).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients aged between 18 \~ 70 with relapsed or refractory multiple myeloma.
•Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination.
•Patients with relapsed or refractory multiple myeloma who meet the following conditions:
•1. Curative efficacy is little or disease progressed after 2 courses of standard treatment regimen;
•2. Disease relapsed after chemotherapy or HSCT. Curative efficacy is little or disease progressed after 2 courses of original treatment regimen;
•3. More than 60 days between last treatment and disease progression;
•4. Autologous or allogeneic SCT is not available at present, or patient refuses to receive SCT;
•5. No response to treatment is defined according to International Myeloma Working Group 2014 version as not achieving CR (including CR, sCR, ICR, MCR) or PR (including VGPR, PR, MR) after 2 consecutive cycles of treatment with current therapy, and the interval between the 2 cycles is no more than 60 days. Disease progression is defined as per 《Chinese Guidelines for Diagnosis and Treatment of Multiple Myeloma》 (Revision in 2015). At least one of the following conditions should be met:Serum M-protein increases ≥ 25% (absolute increase should be ≥ 5 g/L); If serum M protein is ≥ 50 g/L at baseline, increase of serum M protein can be ≥ 10 g/L; Urine M-protein increases ≥ 25% (absolute increase should be ≥ 200 mg/24 h); If the serum and urine M-protein are not detectable, a ≥ 25% increase in the difference between involved and uninvolved FLC levels is required (absolute increase should be ≥ 100 mg/L); Bone marrow plasma cell percentage increases ≥ 25% (absolute increase should be ≥ 10%); Size of existing bone lesions or soft tissue plasmacytomas increases by ≥ 25%, or development of new lytic bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed to plasma cell proliferative disorder (corrected calcium is \> 2.8 mmol/L or 11.5 mg/dL); Disease progression must be confirmed by 2 sequential assessments.
•Expected survival \> 12 weeks.
•Disease is measurable, and at least one of the following conditions should be satisfied:
+10 more criteria

Exclusion Criteria

•Pregnant or lactating women.
•HIV positive, or HCV positive
•Uncontrolled active infection, including active tuberculosis and HBV DNA copies ≥ 1×10\^3 copies/mL.
•Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
•Allergic to immunotherapies and related drugs.
•Patients with heart disease for which treatment is needed or with poorly controlled hypertension.
•Hyponatremia: serum sodium level \< 125 mmol/L.
•Baseline serum potassium \< 3.5 mmol/L (taking potassium supplements before participating in the study to raise potassium level is acceptable).
•Previous treatment with chemoradiotherapy, local treatment ,immunotherapy and tumor-targeting drug conducted 2 weeks prior to participation in this study or blood collection.
•Patients have undertaken immunosuppressor for graft-versus-host disease (GVHD) within 4 weeks before participation in this study or blood collection, or the patient is diagnosed with acute or chronic GVHD.
+1 more criteria

Locations (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

March 23, 2018

Primary Completion Date

June 23, 2020

Completion Date

June 23, 2023

Last Updated

October 8, 2020

Enrollment

ACTUAL participants

Conditions

Refractory or Relapsed Multiple Myeloma

Interventions

CAR-BCMA T cells

GENETIC

Fludarabine

DRUG

Cyclophosphamide

DRUG

A Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination With Lenalidomide and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma

NCT06952478

Refractory or Relapsed Multiple Myeloma

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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