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Table 2 CAR-T clinical trials for solid tumors with published results

From: Chimeric antigen receptor T cell (CAR-T) immunotherapy for solid tumors: lessons learned and strategies for moving forward

Antigen

Identifier

Patients n

Age (median; range)

Dosage

Persistence

Outcome n (median; range) in month

Adverse events

Ref

FR-a

NCT00019136

14 (33–60)

0.3–5 × 1010 T cells

Up to > 1 year

NE: 14

Grade 3/4 toxicities including hypotension and dyspnea as well as less frequently fatigue, leukopenia, rigors, sinus tachycardia, and diarrhea, in some patients receiving IL-2

[35]

CAIX

DDHK9729/P00.0040C

12

62,5 (46–74)

0.2–2.1 × 109

(split dose over 2 × 5 days)

Up to 4 weeks

NE: 12

Transient liver enzyme disturbances (grade 3/4) observed in 4 patients, caused by attack of CAR-T cells to CAIX-expressing bile duct epithelial cells

[36, 115,116,117]

L1-CAM

NCT00006480

6

9,5 (7–16)

1 × 108–1.1 × 109/m2

(split dose; 2–3 times of infusions 14 days apart)

Up to 42 days

CR: 1 (1,5)

SD: 1 (1)

PD: 4

Grade 3 lymphopenia, neutropenia, low hemoglobin and bacteremia caused by 108/m2 CAR-T cells infusion

grade 3 pneumonitis for one patient, which was associated with 109/m2 CAR-T cells infusion

[38]

MSLN

NCT01355965

2

78 (75–81)

3 infusions with 0.1–1 × 109 cells or 8 infusions with 3 × 108 cells and 2 infusions with 2 × 108 cells

Transient (mRNA CAR)

PR: 1 (6)

SD: 1

Anaphylactic reaction in one patient, leading to grade 4 cardiac arrest, respiratory failure, disseminated intravenous coagulation, and CRS

grade 4 jejunal obstruction, grade 3 abdominal pain, and grade 2 lymphcytosis for another patient

[39, 40]

 

NCT01897415

NA

3 times per week for 3 weeks

Transient (mRNA CAR)

SD: 2

Grade > 3 toxicities included abdominal pain (1) and back pain (1)

[41]

HER2

NCT00924287

1

39

1 × 1010 total

NA

Death: 1

Respiratory distress and dramatic pulmonary infiltrate on chest X-ray were observed soon after CAR-T cell administration.

Severe hypotension, bradycardia, gastrointestinal bleeding, resulting in a cardiac arrest.

The patient died 5 days after the CAR-T infusion.

[119]

 

NCT01109095

17

49 (11–79)

1 × 106-1 × 108/m2

Up to 12 weeks

SD: 7

PD: 8

PR: 1

NA

[43]

 

NCT00902044

19

16 (7–29)

1 × 104-1 × 108/m2

(up to 9 infusions)

Up to 18 month

SD: 4 (0,5; 0,5–14)

PD: 13

NE: 2

Fever observed in 1 patient

[28]

 

NCT01935843

11

61 (50–75)

2.1 × 106/kg (range 1.4–3.8 × 106/kg), 1 to 2 cycles

Up to 80 days

PR: 1 (4.5)

SD: 5 (4.8; 1.5–8.3)

Mild-to-moderate fatigue, nausea, vomiting, myalgia, arthralgia, and lymphopenia, Except one grade 3 acute febrile syndrome and one abnormal elevation of transaminase

[42]

EGFR

NCT01869166

11

58 (40–66)

4 × 105–2.54 × 107/kg

Up to 37 weeks

PR: 2 (3; 2–3,5)

SD: 5 (5,5; 2–8+)

PD: 4

Mild skin toxicity, nausea, vomiting, dyspnea, and hypotension; one patient suffered from a transient grade 3/4 increase in serum lipase

[44]

EGFR and CD133

NCT01869166 NCT02541370

1

52

EGFR: 2.2 × 106/kg first cycle, 2.1 × 106/kg second cycle,

CD133: 1.22 × 106/kg

NA

EGDR: PR (8.5)

CD133: PR (2.5)

EGFR: mild chills, fever, fatigue, vomiting and muscle soreness, and a 9-day duration of delayed lower fever

CD133: an intermittent upper abdominal dull pain, chills, fever, and rapidly deteriorative grade 3 systemic subcutaneous hemorrhages and congestive rashes together with serum cytokine release

[45]

IL-13Ra2

NCT00730613

3

57 (36–57)

1.6 × 108 for first cycle + 3 × 108 for second to fourth cycle

(split dose in each cycle; 3 infusions 2 days apart)

Up to 14 weeks

PR: 2 (12; 10–14)

PD: 1

Grade 3 headache in two patients receiving 108 CAR-T cells infusion

grade 3 neurologic adverse events observed in 1 patient

[30]

 

NCT02208362

1

50

Intracavitary infusions (cycles 1 through 6) and intraventricular infusions (cycles 7 through 16), maximum dose: 10 × 106 cells

Detectable at 149 days after enrollment

CR:7.5

No CAR-T cell infusion related toxic effects of grade 3 or higher were observed

[33]

CEA

NCT01373047

7

53,5 (51–66)

1 × 108–1 × 1010 cells

(single hepatic artery infusion)

NA

SD: 1 (23)

PD: 5

NE: 1

Grade 3 fever and tachycardia (1 patient), associated to high-dose IL-2 administration.

grade 1/2 transient elevations of alkaline phosphatase, total bilirubin and aspartate aminotransferase levels observed in all patients

[31]

GD2

NCT00085930

19

7 (3–29)

1.2 × 107-1 × 108/m2 (single infusion)

Up to 192 weeks for ATC and 96 weeks for CTLs

CR: 11

PR: 1

SD: 1

PD: 6

Mild to moderate local pain at the site of tumor necrosis in two patients

[46, 124]

MUC1

NCT02587689

1

5 × 105 cells per lesion

NA

PR: 1

Mild headache, muscle pain, nasal congestion, and abdominal bloating discomfort, and a transient CRS was experienced

[29]

PSMA

BB-IND 12084

5

61 (51–75)

1 × 109–1 × 1010 cells

Up to 4 week

PR: 3

NE: 2

Grade 3/4 hematologic toxicities including neutropenia, neutropenic fever, and thrombocytopenia in all the patients; anemia, hypocalcemia, hypophosphatemia, and appendicitis in one patient.

Grade 1/2 skin rash, fatigue, intermittent low-grade fevers, and muscle pain in some patients

[48]

VEGFR-II

NCT01218867

23

1 × 106–3 × 1010 cells

NA

PR: 1

SD: 1

PD: 21

Grade 3/4 toxicity include nausea, vomiting, hypoxia, and elevated levels of aspartate transaminase, alanine transaminase, and bilirubin

Results available at www.ClinicalTrials.gov

  1. The patient characteristics, CAR-T treatment dosage, CAR-T cell persistence, clinical outcomes, and adverse events of CAR-T clinical trials with published results are listed
  2. Abbreviations: NE no response, CR clinical response, PR partial response, SD stable disease, PD progress disease, NA not available