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Table 3 Clinical advances with promising published results in other BiTE and T-cell engaging bsAbs

From: The landscape of bispecific T cell engager in cancer treatment

NCT identifier

Phase

Indications

Number of patients

Drug

Format

Target

Results

Reference

NCT03625037

1/2

R/R B-NHL

67

Epcoritamab

Fully human IgG1-based bsAb

CD20/CD3

In DLBCL ≥12 mg (n = 18),

ORR: 66.7% (6CRs)

In FL ≥ 0.76 mg (n = 8),

ORR:100% (2CRs)

In MCL (n = 4)

ORR: 50% (1 CR, 1 PR)

[65]

NCT02290951

1

R/R B-NHL

127

Odronextamab

Fully human IgG4-based bsAb

CD20/CD3

In FL ≥ 5 mg (n = 28),

ORR: 92.9% (CR rate: 75.0%) In DLBCL without prior CAR T therapy ≥80 mg (n = 10),

ORR: 60% (CR rate: 60%)

In DLBCL with prior CAR T therapy ≥80 mg (n = 21),

ORR: 33.3% (CR rate: 23.8%)

[66]

NCT02500407

1

R/R FL

62

Mosunetuzumab

Fully humanized IgG1-based bsAb

CD20/CD3

ORR: 68% (CR rate: 50%, PR rate: 18%)

[67]

NCT02924402

1

R/R NHL and CLL

44

XmAb13676

Fully humanized bsAb

CD20/CD3

In NHL 80–125 μg/kg (n = 18),

ORR: 33.3%.

In CLL 20 μg/kg (n = 5):

ORR: 25%

[68]

NCT03075696

1

R/R NHL

38

Glofitamab

Fully humanized IgG1-based bsAb with a 2:1 molecular format

CD20/CD3

ORR:62.5%, CMR rate: 40.6% In aNHL (n = 24),

ORR: 50.0%, CMR rate: 29.2%. In iNHL (n = 8),

ORR: 100.0%, CMR rate: 75.0%

[69]

NCT04082936

1

R/R NHL

14

IGM-2323

Fully humanized IgM-based bsAb

CD20/CD3

Tumor size reduction rate: 64% (2 PRs)

[70]

NCT02520427

1

R/R AML

55

AMG 330

Two tandem scFvs

CD33/CD3

ORR: 19% (CR rate: 7%, CRi rate: 10%)

[52]

NCT03224819

1

R/R AML

30

AMG 673

Two tandem scFvs with Fc region

CD33/CD3

Decrease in blasts in bome marrow rate: 44%

[53]

NCT02514239

1

R/R MM

42

AMG 420

Two tandem scFvs

BCMA/CD3

ORR: 31%

At dose of 400 mg/d (n = 10),

ORR: 70% (5 MRD-negative CRs, 1 PR, and 1 VGPR)

[58]

NCT03287908

1

R/R MM

75

AMG 701

Two tandem scFvs with Fc region

BCMA/CD3

At the dose of 3–12 mg (n = 45),

ORR: 36%;

At the dose of the 9 mg (n = 6),

ORR: 83% (3PRs, 2VGPRs)

[59]

NCT03145181

1

R/R MM

128

Teclistamab

Fully humanized IgG1-based bsAb

BCMA/CD3

At the dose of 1500 μg/kg sc (n = 22),

ORR: 73% (≥ CR rate: 23% and ≥ VGPR rate: 55%)

[71]

NCT03761108

1

R/R MM

49

REGN5458

Fully humanized IgG1-based bsAb

BCMA/CD3

At the dose of 96 mg

ORR: 63% (≥ VGPR rate: 95%)

[61]

NCT03269136

1

R/R MM

30

PF-06863135

Fully humanized IgG1-based bsAb

BCMA/CD3

At the dose of 215 to 1000 μg/kg SC (n = 20),

ORR: 80% (6CRs, 3 VGPRs,6 PRs)

[72]

NCT03933735

1

R/R MM

38

TNB-383B

Fully humanized IgG1-based bsAb

BCMA/CD3

At the dose of ≥40 mg,

ORR: 80% (VGPR rate: 75%)

[64]

NCT03275103

1

R/R MM

51

Cevostamab

Fully humanized IgG1-based bsAb

FcRH5/CD3

At the dose of ≥3.6-20 mg (n = 29),

ORR: 51.7% (6 CRs, 4 VGPRs, and 5 PRs)

[73]

NCT03399799

1

R/R MM

137

Talquetamab

Fully humanized IgG4-based bsAb

GPRC5D/CD3

At the dose of 20–180 μg/kg IV (n = 18),

ORR: 78% (6/6 responded at the 60 μg/kg)

At the dose of 135–405 μg/kg SC (n = 12)

ORR: 67% (3/4 responded at the 405 μg/kg)

[74]

NCT02152956

1/2

PIF and ER AML

38

Flotetuzumab

Two inter-exchange of Fv domains

CD123/CD3

CRR: 42.1% (7 CR, 4 CRh, 4 CRi, and 1 MLFS)

In PIF AML (n = 24),

CRR: 45.8% (5 CR, 3 CRh, and 3 CRi)

In ER AML (n = 14),

CRR: 35.7% (2 CR, 1 CRh, 1CRi and 1 MLFS)

[75]

  1. R/R Refractory/relapsed, IG Immunoglobin, bsAb Bispecific antibody, NHL Non- Hodgkin lymphoma, DLBCL Diffuse large B cell lymphoma, FL Follicular lymphoma, MCL Mantle cell lymphoma, ORR Objective response rate, CR Complete remission, CRh Complete remission with partial hematologic recovery, CRi Complete remission with incomplete hematological recovery, PR Partial response, VGPR Very good partial response, CMR Complete metabolic response, CAR Chimeric antigen receptor, CLL Chronic lymphocytic leukemia, aNHL aggressive NHL, iNHL indolent NHL, scFv Single-chain fragment variable, MRD Minimal residual disease, AML Acute Myeloid Leukemia, MM Multiple myeloma, Fc Fragment crystallizable, IV Intravenous, SC Subcutaneous, Fv Fragment variable, PIF Primary induction failure, LR Late relapse, MLFS Morphologic leukemia-free state