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BCMA-CS1 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-BCMA and CS1 CARs

BCMA-CS1 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

BCMA-CS1 cCAR T cells

Kevin Pinz

Fang Liu, MD, PhD

Hongyu Zhang, MD, PhD

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CS1 cCAR in patients with relapsed and/or refractory multiple myeloma.

BCMA-CS1 cCAR (Compound CAR BCMA-CS1) is a chimeric antigen receptor immunotherapy treatment designed to treat multiple myeloma using two different antigen targets, BCMA (CD269) and CS1 (SLAMF7).

The use of two different targets widely expressed on plasma cells, BCMA and CS1, intends to increase coverage and eradicate cancerous cells before resistance develops in surviving cancer cells that have undergone selective pressures or antigen escape. BCMA-CS1 cCAR bears two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins BCMA and CS1.

BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/Refractory Multiple Myeloma

Phase I, Interventional, Single Arm, Open Label, Treatment Study to Evaluate the Safety and Tolerability of BCMA-CS1 cCAR in Patients With Relapsed and/or Refractory Multiple Myeloma

Assessment of morphologic complete remission (CR), complete remission with incomplete recovery of counts (CR1), no residual disease as analyzed by flow cytometry analysis, and molecular remission by molecular studies

Peking University Shenzhen Hospital

Chengdu Military General Hospital

iCAR Bio Therapeutics Ltd.

iCell Gene Therapeutics

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

* Undergo apheresis procedure for WS-CART-CS1 manufacturing.
* Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician.
* Lymphodepleting chemotherapy on days -5, -4, and -3.
* Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused.
* Part A is the dose escalation portion of the study with the starting dose of 0.5 x 10\^6 cells/kg of WS-CART-CS1.

* Undergo apheresis procedure for WS-CART-CS1 manufacturing.
* Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician.
* Lymphodepleting chemotherapy on days -5, -4, and -3.
* Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused.
* Part B is the dose expansion portion of the study. The dose of WS-CART-CS1 will be determined in Part A of the study.

WS-CART-CS1

* Cyclophosphamide 500 mg/m\^2 IV on Days -5, -4, and -3
* Fludarabine 30 mg/m\^2 IV on Days -5, -4, and -3

Lymphodepleting chemotherapy

Armin Ghobadi, M.D.

John F DiPersio, M.D., Ph.D.

Ravi Vij, M.D.

Keith Stockerl-Goldstein, M.D.

Mark A Schroeder, M.D.

Matthew J Christopher, M.D., Ph.D.

Zachary D Crees, M.D.

Ramzi Abboud, M.D.

Mark A Fiala, MSW, Ph.D.

Feng Gao, M.D., Ph.D.

Despite recent therapeutic advances, multiple myeloma (MM) remains an incurable disease. Although survival has improved, there are nevertheless diminishing durations of response to each subsequent line of therapy. This highlights the need for further therapeutic innovation. BCMA-targeting CAR-T cells show impressive response rates; however, their median duration of response is disappointing. The investigators propose that CS1(SLAMF7)-targeting CAR-T cells will fill a gap in the MM armamentarium.

CS1 is an attractive target in MM because it is expressed in most patients. Elotuzumab (Empliciti®), an approved anti-CS1 antibody, has proven the clinical efficacy of this target. CAR-T cells are an ideal modality to target CS1, given that two approved treatments, ide-cel (idecabtagene vicleucel, AbecmaTM) and cilta-cel (ciltacabtagene autoleucel, Carvykti™), have proven the potential for cellular immunotherapy in MM.

The investigators are testing the safety and preliminary anti-myeloma efficacy of WS-CART-CS1, a CAR-T cell therapy targeting CS1.

Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma

Phase 1 Dose-Escalation and Dose-Expansion Study of the Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma

DLTs are defined as any Grade 3 to 5 toxicity occurring within the 28 days post infusion of WS-CART-CS1 determined to be at least possibly related to WS-CART-CS1. There are some exceptions to this and there are listed in the study protocol.

-Defined as stringent complete response (sCR), plus complete response (CR), plus very good partial response (VGPR), plus partial response (PR), plus minimal response (MR) in MM within 3 months of infusion using the International Myeloma Working Group (IMWG) response criteria in MM.

-Based on next-generation flow (NGF), next-generation sequencing (NGS), or both

-DoR for subjects who respond to treatment is measured from the time measurement criteria are met for response (whichever is first recorded) until the first date that relapse or progression is objectively documented.

-PFS is measured from Day 0 to time of relapse, progression or death, whichever occurs first.

-OS is defined as the time from start of treatment (Day 0) to time of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
BCMA-CS1 Compound CAR (cCAR) T Cells for Relapsed/Refractory Multiple Myeloma	NCT04156269	Multiple Myelom...	BCMA-CS1 cCAR T...	-	iCell Gene Therapeutics
Safety and Efficacy of CS1 CAR-T (WS-CART-CS1) in Subjects With Multiple Myeloma	NCT06185751	Multiple Myelom...	WS-CART-CS1 Lymphodepleting...	18 Years -	Washington University School of Medicine

Spots Global Cancer Trial Database for cs1

Every month we try and update this database with for cs1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cs1

Every month we try and update this database with for cs1 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cs1 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.